Top 10 Clinical Trials Service Providers in 2021

JANUARY 2021

www.swiftnlift.in

Top 10 Clinical Trials Service Providers in 2021

Clinical Trials

industry in India

COVID 19

Statistics, testing and clinical trials

Dr Upendra k. Jain.

CEO

Clinical Pathology

its importance and advancement

Indivirtus

Perfect Blend of Quality and Economy

Swiftnlift Media And Tech SwiftNLift is the Best Business Magazine across the globe for enterprises.

JANUARY 2021

www.swiftnlift.in

Top 10 Clinical Trials Service Providers in 2021

Clinical Trials

industry in India

COVID 19

Statistics, testing and clinical trials

Dr. Upendra K. Jain.

CEO

Clinical Pathology

its importance and advancement

Indivirtus

Perfect Blend of Quality and Economy

E d itor ’ s N ote

I

’ve wanted to be there not just by virtue of being the editor but because I had something to say something that might join us for a moment in that miraculous way words can.

There seems to be an increasing level of confidence displayed by our team in practice, as they realise that the market demand for their skills is growing at an almost exponential rate. Many thanks to my team for the work undertaken.

I am really encouraged by the feedback received from the readers and the institutions/companies which are in association with our magazine.

Some print pieces have complementary components such as additional coverage, advertisements and still photography.

There are regular columns by the editors with reflective articles onto Clinicals Trails and Health Care service providers.

The cover story has featured a very innovative personality DR. UPENDRA K. JAIN (CEO) of INDIVIRTUS. Indivirtus is a CRO that renders real-time cost-effective solutions to the healthcare industry.

SwiftNLift magazine is not just a print or digital anymore but everything we do derives from its long-standing character, approach and quality - while we continue to produce the print publication with as much dedication as ever.

- Nilesh Sabe Nilesh Sabe Chief Editor

INDIVIRTUS

ARTICLE 26 Clinical Pathology: Its Advanced Techniques

36 COVID 19 – Statistics, testing and clinical trials

42 Clinical Trial Industries in India

Cover Story 10

C O N T E N T S 16

ASIATIC CLINICAL RESEARCH

20

ASSAY CLINICAL RESEARCH

22

BIOSPHERE CLINICAL RESEARCH

30

CATALYST CLINICAL SERVICES

32

ETHICARE

34

INDORIV CLINICAL

38

MILAGRO CLINICAL RESEARCH

40

SIRO CLINPHARM

44

MEDONE

READ IT FIRST

SUBSCRIBE

NOW

Yes I would like to subscribe to SwiftNLift Magazine.

Subscription Charges 1 Year . . . . . . . . . (12 Issues) . . . . rs 4200

6 Months . . . . . . (06 Issues) . . . . rs 2100

3 Months . . . . . . . (03 Issues) . . . . rs 1050

1 Month . . . . . . . (01 Issues) . . . . rs 350

Name : Address : Date : City :

Telephone :

State :

Email :

Zip :

Country :

Corporate Office Swiftnlift Media And Tech LLP Office No.101, Nirmal Building, Near Bhumika Medical, Ambedkar Square, NDA Road, Warje, Pune 411058 Phone - +91 7776067659 Email - support@swiftnlift.in For Subscription - www.swiftnlift.in

Cheque should be drawn in favour of : SWIFTNLIFT MEDIA AND TECH LLP

Copyright © 2019 Swiftnlift Media and Tech LLP, All right reserved.

Chief Editor

Managing Editor

Nilesh Sabe

Ravi Borse

Executive Editor

Amar Rathod

Business Developement Manager

Aarti Gandlewar

Graphic design team Art & Design Director

Assistant Designer

Kalyani Patil

Somesh Junavne

Marketing and sales Advertising & Promotions Manager

Vaishnavi Sabe

Digital Marketing

Vishakha Khadse

Marketing Manager

Snehal Bandekar Sales Executives

Pranav Raundale Diksha Purohit

SME-SMO Executives

Arjun Suthar

Contributors

Shiva Borse

Technical team Technical Head

Technical Specialist

Amit Itkhede

Ankush Katre

Technology Consultant

Circulation Manager

Pallavi Surwase

Ashvini Mahajan

JANUARY 2021 For Marketing & Advertising Reach us at: sales@swiftnlift.in Follow us on

Top 10 Clinical Trials Service Providers in 2021

“To be among the top ten globally competent healthcare consultants, capable of providing time-efficient and accurate solutions with highest integrity, as well as a challenging and growth-oriented environment around our team members so that they have a great sense of pride and achievement.”

Dr. Upendra Jain

Top 10 Clinical Trials Service Providers in 2021

Indivir tus

Introduction  Indivirtus is a CRO that renders real-time cost-effective solutions to the healthcare industry. Indivirtus aids the healthcare professionals and industry to maximize efficiencies in their core competencies while taking care of support services and help the organizations in their commercial development.  The vision of the company is “To be among the top ten globally competent healthcare consultants, capable of providing timeefficient and accurate solutions with highest integrity, as well as a challenging and growth-oriented environment around our team members so that they have a great sense of pride and achievement.”  With the enthusiastic aspiration of reaching onto the top position in the days to come, the company believes to expand the business and approach of providing the best service in this sector. Their mission is to facilitate the customers with high quality outcomes and financial prudence by creating and nurturing a team of highly competent and innovative professionals and state of art technology to deliver complete satisfaction with precise finesse and excellence.

History of the company and its backbone  Indivirtus was founded in the year 2018 and is a self-financed company located at Chandigarh and Mohali. The company was launched by extremely talented and innovative Dr Upendra k. Jain. He is currently the CEO of the company. He has served pharma companies for 15 years in

Sales and Marketing department and educational sector for more than 12 years before starting Indivirtus Healthcare Services Private Limited. An experienced and dedicated team of 28 employees are the backbone of Indivirtus for providing end to end and speedy solutions using high end hardware and software in clinical trials, pharmacovigilance and calculation of PDE & OEL values.  As the name suggests, Indivirtus is an Indian company with Virtuousness (honest, trustworthy, truthful with moral ethics) and was incorporated in March 2018 with an aim to target growing sector of pharmacovigilance. This was the time when domestic companies were gearing up to initiate pharmacovigilance activities which included the detection, assessment, understanding and prevention of adverse effects or any other problem pertaining to the drugs. Pharmacovigilance (PV) collects the safety related information to determine the benefit or risk impact. PV aims to support public health programs by providing reliable, balanced information and to enhance patient care and its safety.  As the domestic companies were preparing themselves for PV activities, Indivirtus had to struggle for about 6 months to actually start the operations. During this period Dr. Jain was building relations with industry experts and seeking their opinions about

industry requirements. During one such discussion with Mr. Manoj Sharma (An Industry with more than 35 years of experience) an idea emerged to start calculation of PDE (Permitted Daily Exposure) values as this was an immediate requirement of pharma companies who supply their products to Europe and US. Even though Dr. Jain was novice to this business but his determination, dedication, intelligence, the cordial relationship with clients and colleagues helped him to flourish in this business and reached at zenith of success ladder. This is how Indivirtus had its first ever sponsor on board and thus the ever-growing journey of Indivirtus begun.

Therefore, “the credit of starting this enterprise goes to Mr. Manoj Sharma,” Dr Upendra K. added.

Complete information about Indivirtus can be accessed at: https://indivirtus.com

Characteristic Features Indivirtus is committed to integrity, world class quality and excellent customer service. It endeavors to achieve this niche position through constant innovation, up-gradation and customer satisfaction while operating under an effective quality management system.

Indivirtus Healthcare is the only company with:  End to end pharmacovigilance and clinical trial services by team of professionals with global exposure  6 Certified Toxicologists Average output of 40 PDE/OEL reports per week in EMA format  Experience of preparing more than 2500 PDE/OEL reports  Served more than 100 Clients in just 24 months  GxP services offered by highly experienced and competitive person

Transformation and upgradation  As rightly said, change is the only constant.

Similarly, there are constant changes and updates in the regulatory guidelines. Team Indivirtus keeps itself updated with the newer guidelines of different regulatory authorities’ i.e. MHAR, USFDA, WHO, PICS, APIC etc. and accordingly it makes necessary updates in its services. The company is always on toes to align day to day introduction of updated regulatory guidelines.  One such example is calculation of health-based

exposure limit (PDE/ADE/OEL calculation) based on NOAEL values and Indivirtus was quick enough to introduce this service and help the pharma industry. At the same time, it has grabbed the opportunity to become the market leader. Today due to the remarkable quality of the service that too at an economical price, the company has served more than 100 international and domestic companies for calculation of PDE values. The European Medicines Agency’s (EMA) scientific guidelines are followed for calculation of PDE values. Guidelines of International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) are also referred while preparing these reports. ICH guidelines provide guidelines on quality, safety, efficacy, multidisciplinary considerations.

Clients Satisfaction with Indivirtus With Indivirtus clients do get a perfect blend of quality and economy. After outsourcing their

work to Indivirtus, clients are rest assured that the task will be done with best quality as per regulatory guidelines that too at an economical price.

Outreach and Credibility Due to the excellent and hardworking team, Indivirtus has served more than 100 clients in just 2 years. The positive and trustworthy approach towards the clients and employees as well as the quality of the work has built the name and fame for Indivirtus company all over.  The satisfactorily service by the company led to the word-of-mouth recommendations from one client to another. Every company grows only when they build a sense of trust and belonging with its employees. For Indivirtus its employees are family members.  Indivirtus Provides a dynamic innovative and challenging environment to the employees and as a result, they become more confident in their field. Indivirtus employees also do have plethora of opportunities for vertical growth in their career.  Indivirtus conducts time to time training sessions for the all the employees which helps them to enhance their knowledge.  BD team of Indivirtus gets benefit by interacting the overseas clients which aids them to increase their oratory prowess.

New strategies and its implementation Pharma industry is an ever-growing industry with introduction of new drugs to treat various ailments in a better, safer and quicker manner. Safety of patients at each stage is very important.

In the ever-growing market of pharmaceuticals, new plans and strategies plays a vital role in improving quality of life of the patients. Indivirtus has strategies to help the pharma industry in order to ensure patients safety at three important stages: ■ Establish safety of new drug introduction during clinical trials.

■ Lessening cross contamination during manufacturing of the drugs by calculating permitted daily exposure limits (PDE).

■ Processing the adverse drug reactions encountered by patients under pharmacovigilance program.

Upcoming facilities and enhancements Indivirtus and Patients Safety are the synonyms in pharmaceutical industry. Similar type of service i.e. bio-equivalence studies and medical scribing services are the new services which industry may expect from Indivirtus in days to come.

Medical scribing will be a very generous facility provided to the patients.

Bioequivalence studies are imperative for the development of a pharmaceutical preparation in the pharmaceutical industry. It will monitor the pharmacokinetic and pharmacodynamic parameters after the administration of tested drugs.

ASIATIC CLINICAL RESEARCH

A

siatic Clinical Research is a full-service clinical research organization (CRO) headquartered in Bangalore, India. We focus on Phase II - IV clinical trial support to pharmaceutical, biotechnology and medical device companies. Our strength is in strategizing what is exactly needed for your clinical trial by conducting a good literature search, providing world class facilities, KOL in specific indications treatment naïve patient pools. Asiatic has access to ICH-GCP trained sites in metros and tier II cities. Mr. Bindhu Aravapalli is the Managing Director of Asiatic is based in Atlanta GA. He has a flair and deep interest for life-science ventures.

He is the founder and one of the principal investors of Asiatic. Prior to this, he was a co-founder of FAST Inc. NY. Bindhu worked as CEO of FAST from 1993 to 1999 and achieved revenue of 20 million USD. Previously, he had worked at IBM in Rochester, MN.

Vision: To become a Global CRO by integrating technology and nurturing captive sites from tier II cities to bring a larger pool of investigators and patients into the clinical research world that would enable quicker new drug development.

Mission: We adhere to the best international practices in clinical research while maintaining the highest ethical standards in our services.

Investors Mumbai Angels are a unique forum where its members 16

may interact and exchange ideas and knowledge. Mumbai Angels provides a unique platform to start up and very early-stage companies by bringing them face to face with successful entrepreneurs, professionals and executives who are interested in and have the funds available to invest in start-up companies.

Services Asiatic understands the importance of the highest quality regulatory submissions. We have a full-time employee who works out of New Delhi to ensure regular coordination with the DCGI officials. Asiatic supports in the design and planning of your clinical Protocol.

Drawing on our experience across various therapeutics areas we work with sponsors to define the trial objective, methodology and design of the specific trial.

Expertise Literature survey, review and meta-analysis and Complete Protocol Development considering the Sample Size Estimation, Blinding, Randomization and the power calculation needed for the specific trail.

It is Asiatic’s constant endeavours to exceed sponsor expectation in achieving the objective for their rapid clinical development program.

Project Management: Projects are competently handled by the experienced Project Managers at Asiatic. Project Managers help in planning and management of the clinical trials from beginning to end with periodic communication. Our main focus is on providing quality deliverables, within timelines and budget JANUARY 2021

SwiftNLift

Top 10 Clinical Trials Service Providers in 2021

MR. BINDHU ARAVAPALLI Managing Director

Clinical Monitoring: Each CRA at Asiatic brings a wealth of monitoring experience. Our lead CRAs develop and manage highly functional sites across India. Our CRAs help in communication between the sponsor and principal investigators throughout the clinical study. Our CRAs conduct continuous on-site monitoring, training for the CRCs and the co-investigator.

Clinical trial supply management: Asiatic capabilities include warehousing and distribution of investigational drugs and clinical supplies. These services are often provided as a part of a full clinical services contract but can also be availed of on a standalone basis.

Asiatic has a walk-in cold storage room with automatic alarm system. This facility has a commercial license issued by the Assistant Drug Controller of India.

Asiatic has worked largely with global clients in providing CTS management for their clinical trials, the majority being multi-centric Phase III trials. Our facility has been audited by all our sponsors.

JANUARY 2021

SwiftNLift

Site Management: Clinical Operations team works with the sponsor to prepare a feasibility report based on the inclusion / exclusion criteria as per the protocol. Sites are selected based on various parameters like access to specific patient population, previous experience in specified indication and therapeutic area. Sites are also selected based on the infrastructural requirements which are useful to govern the trials. The project manager will work closely with each site and the principal investigator to develop successful recruitment and retention strategies for the subject’s participating in the clinical trial.

Quality Assurance: Quality Assurance (QA) is an independent function that reports to the top management. The goal of QA is to promote excellence by ensuring adherence to ICH – GCP and SOPs. The team ensures that the ethical conduct of the clinical study, documentation and reporting of the data is in compliance with ICH-GCP and regulatory guide lines.

17

The documentation is facilitated by use of checklists and forms for reporting observations and deviations. The QA team also prepares audit reports and compliance reports.

within the stipulated time frame Medical writing is a very important facet in the clinical research to prepare the final clinical report.

The team assures that all observations and findings are verified for the credibility of the data and that the conclusions presented are correctly derived from the raw data generated. The verification process is specified and justified with the in-house systems, procedures and applicable regulatory guidelines.

At Asiatic our medical writers work collaboratively with our experts in clinical operations, regulatory affairs, biostatistics and clinical data management departments to report accurate data and the results generated during the course of the clinical trial

Medical Monitoring, writing and data management: Our medical monitors come from experienced medical background. They are able to apply their practical knowledge and clinical experience to present solutions for the issues occurred during the conduct of the clinical trial. Medical Monitors work as per the ethical guidelines for the safety of the subjects and document and communicate the AE and the SAE occurred during the trial to the regulatory agencies, sponsor and the IEC

18

Asiatic Clinical Research offers Data Management services as part of the full-service package. During project execution, Asiatic focuses on full team involvement and communication with the sponsor so that the end result is a clean database delivered on time. Along with Clinical Data Management Services, Asiatic offers Bio stats as part of the full-service package. We work with experienced statisticians to offer an array of statistical services.

Asiatic Clinical Research offers excellent career growth opportunities. We are looking for professionals who can contribute their best potential in a rapidly growing and dynamic environment

JANUARY 2021

SwiftNLift

ASSAY CLINICAL RESEARCH

A

SSAY is a technology driven company, focusing on developing innovative tools and software solutions for running clinical trials. It believes in efficiency through technology and expertise. With a competent IT team based in India, ASSAY builds robust and customized solutions based on the project needs to increase the efficiency and quality of the outcome. Its software systems are innovative, intuitive, customized and in-line with the latest technology.

Top 10 Clinical Trials Service Providers in 2021

ASSAY started off in 2012 with a group of clinical research professionals providing project management and clinical trial management services.

ASSAY brings you innovative clinical trial management solutions based on the latest emerging technology. It does develop strategies for running a clinical trial effectively and efficiently. The services are offered to pharmaceutical, biotech and medical device companies, as well as other CROs, vendors and healthcare professionals who would benefit from its tailored approach.

Its Mission Patient Safety and Quality Data are of utmost importance for ASSAY. We achieve these through implementing the right resources and technologies for managing trials, ensuring that our collective experiences make the maximum contribution to the success of a clinical trial.

Its Vision ASSAY aims to become global leaders and pioneers in in delivering our services of clinical trial management together with technology and be the first to become a futuristic clinical research organisation ASSAY employs a great deal of time and efforts to ensure that milestones are met with quality data. The dedicate is more towards planning and implementation of risk 20

management strategies and measures to check and improve quality as deemed by the study or scenario. In countries with increased risks and concerns, ASSAY by default includes additional site and CRA quality assessment visits throughout the study duration to ensure the risk factors are addressed and a strong CAPA is in place. ASSAY will also provide consultation, customized systems and strategies of highest quality standards for any challenging project/country.

It assists in every possible way with the experience in a wide range of therapy areas and the ability to handle challenges and complications in any clinical trial.

The modern world is replete with technological solutions for every activity you can imagine. Clinical research is no exception. But the need for tailored intuitive solutions continues to exist. It can take many years for a molecule to travel from laboratory concept to marketed product.

It is important that the molecule is given the utmost attention and support at every phase of its clinical trial journey.

ASSAY’s experts assist the clients with the best experienced team of talented, trained individuals in trial management and delivery. It also did spread its wings into West African region, which includes the JANUARY 2021

SwiftNLift

joint training initiative to run clinical trials.

The key to Client satisfaction is understanding the project needs and delivering accordingly.

At the outset ASSAY works hard to agree on what is best for the project. Its expert advisors carefully analyse the customer’s requirements.

Successfully assessing feasibility is a vital step before embarking on an expensive clinical trial.

Making the right choices during site selection is key to the positive conduct of the trial. ASSAY aims to complete this phase quickly and effortlessly with quality results. e-Feasibility provides the ability to create study specific questionnaires and share it with potential investigators and track the progress of completion.

With robust reports, the project management team will find e-feasibility the perfect solution to recruit potential investigators to the study in the shortest possible time. Good management is bringing the right people and right ideas together at the right time and transforming thoughts into action and output. The team of expert managers and their associates bring the best management practices to provide a quality outcome, efficiently and cost-effectively. Be it project management, data management or safety management, its dedicated team handles and deliver every task within the stipulated timeframe and helping to achieve every project milestone.

In clinical research, being organised is a prerequisite of success. Bringing the right resources to bear at the right time is a challenge. This is particularly applicable for document management for a clinical trial. GRAVITY is the long-time solution for site file and trial master file management. ASSAY has converted both files into easy to manage, co-ordinated electronic format. This integrated package facilitates logical and convenient document management.

SUDHARSHAN M. CHANDRAN Managing Director

clinical research environment can be stressful and could eventually drain the energy of even the most committed employees. Successful training should energise and enhance the learner’s abilities. When the process of training and tracking is simplified, the result is usually enhanced engagement. ASSAY Academy is the unique single window training management system for project team and site team to train and track project specific trainings with ease. ASSAY has a team expertise in regulatory consultation and process evaluation. Every clinical trial application submitted by it to the regulatory authorities and ethics committees is rigorously scrutinised. That way the customers can be sure that the appropriate permissions are granted as early as possible.

Along with other services it also submits the drug information for marketing licenses.

The constant ongoing training requirements of the JANUARY 2021

SwiftNLift

21

BIOSPHERE CLINICAL RESEARCH

B

iosphere Clinical Research is a venture founded by top-level industry professionals.

The bouquet of high-quality services delivered by Biosphere includes Clinical Operations, Remote Monitoring, IWRS (e-Prudent), Data Management, Statistical Analysis, Regulatory Affairs, Medical Writing, Pharmacovigilance and Quality Assurance.

Founded in 2012, Biosphere Clinical Research Private Limited offers world-class expertise and technology to ensure successful Clinical trial management, data collection and documentation for clinical trials spread across the globe.

The experts at Biosphere anticipated the benefits of incorporating latest technologies in the activities of clinical research and came up with e-Prudent; its unique solutions for IWRS and Remote monitoring. Also, it serves clients by recruiting the best project resources, bringing in the latest technology and utilising expert consultation.

Biosphere offers tailor-made solutions with a personalised approach for specialised clinical research projects. With cost-efficient operations, backed by its global support team which delivers effective and accurate results for client projects.

These results help the clients to bring key medical remedies sooner to the patients in the market.

Vision To change lives of thousands of people worldwide, by bringing in safe, advantageous remedies and supplements to the market.

Biosphere is a reliable firm delivering clinical 22

research services in India and globally. The services provided includes clinical operations, remote monitoring, data management, statistical analysis, regulatory affairs, medical writing, pharmacovigilance and Quality Assurance. As an experienced clinical research consultant, it helps clients with clinical research management and regulatory management expertise. Right from evaluating a project proposal to closure of the clinical trial with necessary clearances and documentation, Biosphere handholds the clients at every stage of the project. It has created e-Prudent, a revolutionary online platform for remote monitoring that includes an Interactive Web Response System (IWRS). The e-Prudent system supports Project Managers and Clinical Research Associates (CRAs) to quickly mitigate risks. It also offers training programmes for project coordinators, sponsors and monitor the usage across India and globally.

Quality Biosphere’s endeavour is to bring in the highest quality data for successful clinical trials. To do so, the company follows Standard Operating Procedures (SOPs). The clients get the assurance that the project management practices and outcomes are as per global quality standards and in compliance with the prevailing laws.

Promptness Timely acquisition of data and recruitment of patients as per project requirement is essential for JANUARY 2021

SwiftNLift

Top 10 Clinical Trials Service Providers in 2021 meeting deadlines. It is channelized to connect all the ends for preventing delays and delivering a cost-effective project.

Ethics Biosphere makes every effort for carrying out tasks at each stage of a clinical trial project as per the industry-defined ethical standards. With its strong ethics, it does win the trust of the esteemed clients and also of the governing bodies locally and globally.

Safety and Confidentiality Biosphere follow stringent safety and confidentiality guidelines for the safety and protection of patients who are part of clinical trial projects managed by it.

Pharmacovigilance Safety is a key component of any clinical trial. The pharmacovigilance services team at Biosphere helps project sponsors to create safety JANUARY 2021

SwiftNLift

DR. NEETA NARGUNDKAR Managing Director

management plans to avoid unfortunate trial outcomes. Maintaining safety standards adds to trial integrity, patient safety and reputation of the project sponsor. Additionally, the safety standards followed by the project sponsor determines the outlook of the regulatory authorities towards the project sponsor.

Clinical trial projects test drug variants to discover a solution to a problem. Every effort is taken care by the trial team to understand the safety concerns in the procedure in a clinical trial project.

Since every project has a different scope, Biosphere creates a safety management plan by studying all ends of the project that it works on. Biosphere can efficiently deliver the safety reports at a faster pace so that necessary steps can be taken to tackle issues on time.

Remote Monitoring A clinical trial is complex in nature. Earlier, traditional methods of monitoring clinical trials were used by sponsors for clinical trial projects.

The data was captured on paper and then updated 23

in to machines for further processing. These procedures were time-consuming and usually led to project delays. Tracking the progress of the trial was difficult for sponsors due to distance and processes. But today with modern technologies a lot has changed.

Now, remote monitoring for clinical trials has become more efficient. Saving time while retaining the quality standards for optimum results is essential in clinical trial management. Based on these grounds, we have developed a reliable system for offering remote monitoring clinical trials services. Checking trial status by multiple team members can also affect the trial. Patient remote monitoring data can now be easily accessed with centralised systems that provide all the data points at your fingertips. Biosphere have developed a welldesigned system for delivering intelligent clinical monitoring services that are in alignment with the international compliance standards.

Medical Writing

Be it academic writing, regulatory writing, clinical writing or medical writing for specific projects, its medical writing services can plan and deliver the content as required. The writing team works in co-ordination with its pharmacovigilance team, QA team, data management team and other team’s part of a project to create the necessary documentation for clinical trial projects.

It provides a well-written documentation for the product development efforts by delivering high-quality services globally. Its qualified team of writers and editors has vast experience in managing medical content. With their expertise, Biosphere helps clients to compile, organize, write, edit and produce a wide range of medical scientific documents. Based on the document needs of the clients, Biosphere creates documents that demonstrate excellent language usage, clear communication and adherence to scientific writing standards. It also provides cost-effective clinical writing consultation services for projects of various scope and scale.

One of the specialities biosphere has is in Medical content writing!!!

24

JANUARY 2021

SwiftNLift

CRAFTSFAIR

Clinical Pathology: Its Advanced Techniques Clinical Pathology Clinical pathology is a subspecialty of pathology that deals with the use of laboratory methods (clinical chemistry, microbiology, haematology and emerging subspecialties such as molecular diagnostics) for the diagnosis and treatment of disease. Haematology studies the blood and blood-forming tissues to evaluate presence of disease and assist in therapeutic interventions as clinically indicated.

Clinical pathology is one of the two major divisions of pathology, the other being anatomical pathology. Clinical pathology is itself divided in to subspecialties, the main ones being clinical hematology/blood banking, clinical chemistry, 26

hematopathology and clinical microbiology and emerging subspecialties such as molecular diagnostics. Hematology studies the blood and blood-forming tissues to evaluate presence of disease and assist in therapeutic interventions as clinically indicated. Clinical chemistry (also known as chemical pathology and clinical biochemistry) is the area of clinical pathology that is generally concerned with analysis of bodily uids.

Blood parameters play a critical role in diagnosis, assessing progression, and in the characterization of disease and phenotypes in clinical and research situations. e accuracy and reliability of the whole blood parameter analysis depends on identication JANUARY 2021

SwiftNLift

and control or elimination of variables that may aect these results. Dierent blood collection and handling strategies represent source of variability that can be controlled in many instances.

Basic hematological procedures such as the complete blood count are frequently conducted to help physicians and veterinarians arrive at a diagnosis and prognosis, also to evaluate treatment. Hematology testing includes, but is not limited to: Hematology Sample Processing, Hematology Research Services, Hematology Automated Testing, Lamellar Body Counts, Microscopic Cellular Analysis, Body Fluid Analysis and Specialized Stains. e outline of this laboratory manual deals with the basic hematological procedures and clinical chemistry analysis which is meant for students use. e study of hematology begins with proper sample collection and handling. Part one deals with hematology containing dierent sections.

Part two covers clinical chemistry including functional tests. All of the procedures described in this manual are classical methods that are routinely performed in a standard clinical pathology laboratory. Detail procedures including preparation of reagents, solutions, stains and buers are given. Calculations of blood indices and chemical analysis are also discussed in part one and part two respectively Clinical pathology is one of the two major divisions of pathology, the other being anatomical pathology. Haematology studies the blood and blood-forming tissues to evaluate presence of disease and assist in therapeutic interventions as clinically indicated. Clinical chemistry (also known as chemical pathology and clinical biochemistry) is the area of clinical pathology that is generally concerned with analysis of bodily fluids.

Blood parameters play a critical role in diagnosis, assessing progression, and in the characterization of disease and phenotypes in clinical and research situations. The accuracy and reliability of the whole blood parameter analysis depends on identification and control or elimination of variables that may affect these results. Different blood collection and handling strategies represent JANUARY 2021

SwiftNLift

source of variability that can be controlled in many instances. Basic haematological procedures such as the complete blood count are frequently conducted to help physicians and veterinarians arrive at a diagnosis and prognosis, also to evaluate treatment. Haematology testing includes, but is not limited to: Haematology Sample Processing, Haematology Research Services, Haematology Automated Testing, Lamellar Body Counts, Microscopic Cellular Analysis, Body Fluid Analysis and Specialized Stains.

Advanced Clinical Pathology Techniques for Detecting Emerging Infectious Disease Pathogens Advancements in medicine have prolonged the life expectancy of individuals all over the world. Once life-threatening conditions have become significantly easier to treat and even cure in many cases. Continued research in the medical field will further improve the quality of life, longevity, and wellbeing of individuals.

The more commonly used advanced techniques include immunohistochemistry (IHC), in situ hybridization (ISH), polymerase chain reaction assay (PCR), and tissue microarrays.

Immunohistochemistry Immunohistochemistry (IHC) is the most common application of immunostaining. It involves the process of selectively identifying antigens (proteins) in cells of a tissue section by exploiting the principle of antibodies binding specifically to antigens in biological tissues. A large number of IHC is available that can be helpful in the identification of microorganisms. By using a variety of antibodies, IHC can detect the presence of microbial antigens in tissue specimens, whether they represent the intact or degraded pathogens, and whether they are intracellular or extracellular.

Therefore, IHC has become a powerful technique used by pathologists for tissue diagnosis of infectious diseases.

Another advantage of using IHC is its capability of detecting well-preserved microbial antigens in archived formalin-fixed, paraffin-embedded (FFPE) tissues, which allows retrospective studies of many emerging pathogens even after decades of archive.

27

In Situ Hybridization In situ hybridization (ISH) is a type of hybridization that uses a labelled complementary DNA, RNA or modified nucleic acids strand (i.e., probe) to localize a specific DNA or RNA sequence in a portion or section of tissue or if the tissue is small enough (e.g., plant seeds, Drosophila embryos), in the entire tissue (whole mount ISH), in cells, and in circulating tumour cells (CTCs). This is distinct from immunohistochemistry, which usually localizes proteins in tissue sections. ISH is a technique that uses fluorescent or radiolabelled nucleic acid probes comprising complementary DNA or RNA strand to localize specific sequences in tissue sections.

PCR assays can be performed directly on genomic DNA samples to detect translocation-specific malignant cells at a sensitivity that is at least 10,000-fold higher than that of other methods.

PCR is very useful in the medical field since it allows for the isolation and amplification of tumour suppressors.

PCR amplification undoubtedly is the most sensitive method available to detect microbial organisms in tissue specimens and has become a common practice in many pathology laboratories.

PCR can be performed on FFPE samples therefore, diagnoses can be made even if cultures were not obtained initially from biopsy or autopsy at the time of processing

Microarrays Polymerase Chain Reaction Assay 28

A microarray is a laboratory tool used to detect JANUARY 2021

SwiftNLift

the expression of thousands of genes at the same time. DNA microarrays are microscope slides that are printed with thousands of tiny spots in defined positions, with each spot containing a known DNA sequence or gene.

Microarrays can be performed on frozen tissue samples and may be helpful when multiplex PCR or other nucleic acid methods fail. However, the sensitivity is generally lower than those multiplex PCR methods. Viral microarrays can be roughly divided into those targeting 10–100 agents and those designed for detection of thousands of agents, including unknown pathogens.

Other Advanced Techniques Other advanced pathology techniques such as confocal microscopy, proteomics, laser capture microdissection (LCM), and in situ PCR have been JANUARY 2021

SwiftNLift

used sparingly for detecting novel pathogens in a few specialized laboratories. Although they can become potentially powerful tools for diagnosis of emerging infections, most of them remain as pilot utilities and need further optimization to gain wide acceptance as mainstream techniques in practice of infectious diseases pathology.

Diagnosis with pathologic techniques provides histomorphology correlation for a specific infectious agent with the disease it causes and is essential for identifying the cause of death. There are limitations of using pathologic techniques despite the advantages. Because immune mechanisms can greatly amplify the host response, the actual numbers of pathogens present in tissues can be relatively small. This means that many sections may need to be examined before a pathogen is identified.

29

CATALYST CLINICAL SERVICES

C

atalyst Clinical Services Private Limited is a Contract Research Organization that acts as a strategic partner to the healthcare organizations (Pharma/Biotech companies, Research and Academic Institutions) making them winner by building on their core competence and empowering them to counter threats. The primary focus area is Clinical Trials Management and Execution, Medical Writing, Independent Auditing and Clinical Research Training.

With regards to clinical research and pharmacovigilance training, Catalyst has made pioneering initiatives and has established itself as India's largest clinical research and pharmacovigilance training providers both in terms of numbers as well as geographical reach. The contract clinical research services of Catalyst have been widely appreciated by the key stakeholders at National as well as International level. Its key strengths include service excellence, total quality management, strict adherence and compliance to GCP guidelines, cost effectiveness and thorough understanding of local and global regulatory policies and processes.

Mission To meet the ever-growing knowledge and compliance need of clinical research profession, thereby making Indian clinical research industry a benchmark to the global clinical research''

Values Catalyst values to firmly maintain the professionalism, service excellence, quality, dedication, flexibility and work ethics.

30

Top 10 Clinical Trials Service Providers in 2021

Strengths  Service Excellence  Total Quality Management  Adherence and Compliance to GCP and applicable Regulatory Guidelines  Cost-Effectiveness  Thorough understanding of local and global regulatory policies and processes

Therapeutic Area Expertise The company has hands on experience of working on various phase II, III and IV clinical trials in the therapeutic areas of Oncology, Endocrinology, Critical care, Cardiology, Andrology, CNS, Ophthalmology, Infectious Diseases and Medical Devices with various Indian as well as multinational pharmaceutical companies.

Services  Feasibility

Assessment,

Project

Milestone

JANUARY 2021

SwiftNLift

Planning and Forecasting  Cost Estimate and Financial Planning  Logistics Planning, Vendor Selection and Management  Investigator Selection

Site

Assessment

and

 Management of the Dossier Submission to Ethics Committee and Regulatory Authorities  Management of Import/Export logistics  Co-ordination Activities

for

Individual

Site

Set-up

 Inventory Planning and Tracking  Organization of Investigator Training Meeting

Director

 Study Initiation and Conduct  Tracking of Enrolments and Payment of Study Grants  Quality

JANUARY 2021

Control,

SwiftNLift

Quality

SANJAY GUPTA

Assurance

Regulatory Compliance

and

31

ETHICARE E

thicare is a pharmaceutical company in India which focuses in dermatology and cosmetology. It was founded in 2003 by a young and enthusiastic entrepreneur, Ilesh Khakkhar. The organization has been dedicated to innovation through new regimen, new medicine, new technologies and new ways to beautify the world. It is a market & customer driven company and regularly launch innovative and quality products for skin, hair & body, in response to genuine requirements expressed by the customers & also to make new trends in cosmetology.

Since inception, the organization has been working to bring significant change in the quality of life and the quality of beauty. Constant research and development help us to deliver products with newer features and enhanced applications. Ethicare strives to invent products that stand apart in their uncompromising quality. Its products make the skin and hair feel awesome, they restore and brighten an individual’s outlook.

Ethicare promotes the products in ethical way to dermatologists, cosmetologists and plastic surgeons.

Working closely with dermatologists and cosmetologists means that Ethicare offers revolutionary ingredients, breakthrough formulas and advanced technology. It is designed not only to deliver exceptional results but to enhance the integrity of any individual’s skin. Its solely focus is on dermatology and cosmetology that has helped them to get high regards in the eyes of all leading dermatologists and cosmetologists across the countries that it represented in.

MISSION Ethicarians are always in the transition mode to empower its clients through better products and 32

constant upgradation & transformation of knowledge at all levels in fun way.

VISION l Empowering individuals l Building a better and healthier world l Becoming the most disruptive, innovative & indispensable healthcare company.

Achievements and Revolutions With its best efforts and experience that the team had in the field over the years & love the company had got from the clients had helped them to introduce its new division. In 2010, a new firm was introduced Ethinext Pharma, with the vision to cover clinical dermatology through pharma products. And in the beginning of 2015, it came up with premium product segment through its new project called Ethiall to cover the niche area of cosmetology.

Ethicare’s highly experienced team enables them to respond in most flexible manner to the individual needs of its customers.

Ethicare takes pride in being pioneer of most of its products which is result of their mantra: "Creativity & innovation are our fuel."

Ethicare’s commitment to quality, value and innovation has led to highly visible, category-leading brands in Indian market. After successful establishment in India, it has started exporting its products in countries like Mauritius, UAE, Bangladesh, Yemen, Nepal and Afghanistan. The company is aiming to expand globally.

It is satisfied with its excellent relationship with the JANUARY 2021

SwiftNLift

Top 10 Clinical Trials Service Providers in 2021 distributors, built day after day in several years of hard work. Ethicare stands high will determination and never stops to dare and to grow, driven by its passion for what it does.

Ethicare believes in the thing to be a life-long-learner and keep evolving. It does provide value to everyone whoever connects with it. It also does help colleagues and clients and do whatever it takes to support them.

Innovation always led to progression and development; thus, it provides world-class quality in work, service and products. It challenges the status quo and approach its business with creativity, fresh ideas and commitment to do things in a new and meaningful way.

MILAN SATIA

President & CEO trends into the industry. It thinks forward and build the next generation solution for clients and employees.

It believes in risk taking and developing more leaders.

Ethicare strives to be the magnet to attract good quality people to work with, including customers and employees. It works proactively with determination and perseverance. The company is like solution driven.

Ethicare is owned by its key people and their valued contribution helps Ethicare grow & shine.

Integrity always stands at the top for any organisation or company. Ethicare does the right things at all times.

It acts with honesty, accountability & transparency. It is committed to being open, transparent & honest in all the activities. Any company grows only when it gets the strength of its team. Determined teamwork creates work with more quality. It does accomplish everything together. It does believe in delivering above and beyond the expectation by delegation, empowerment and accountability.

The company always keeps itself updated to the recent JANUARY 2021

SwiftNLift

33

Indoriv Clinical Private Limited

I

ndoriv Clinical Private Limited started in Health Point Hospital, Kolkata as a clinical research consultancy in 2012. It does study on stem cells in patients with critical limb ischaemia – A rare heart disease which is a result of excessive smoking and unhygienic conditions.

It all started with a generous idea of serving the patients who could not afford basic necessities such as fruits or milk. It kept hammering the thought of dealing with the patients below the poverty line and to compose a healthy lifestyle for them. Though it was a challenging task, but Indoriv didn’t give up.

The team researched on what was locally available to them that they could afford and advised them on the same and helped several patients throughout the country.

Top 10 Clinical Trials Service Providers in 2021

help them correct their composition and nutritional habits without the use of medicines.

Until now Indoriv has completed several clinical trials from hard core cancer drugs to pain drugs to skin products, food products & many more. It has helped more than 2000 patients get their life on track by helping them both medically and plan their nutrition & lifestyle. While the drugs and medicines remain the same their nutrition & lifestyle are miles apart.

Key Processes

Every patient is unique in its own way and as a company that fascinates it. Indoriv completely understands how to maintain a balance between stereotype and personal nutrition because of the experience across the spectrum with patients having virtually all the diseases that anyone could think off.

IP Management: The test product/investigational product/main medicine needs be maintained, and their storage conditions have to be perfect.

While moving on with all these activities the company finally decided to do this on a one-to-one basis with real patients and Infinite Health was born.

It developed themselves into nutrition and lifestyle consultation company with an aim of preventing lifestyle and mobility disorders. The company got thoroughly into the science of every person and 34

■ Ethics Committee (EC) Management: All studies/ clinical trials have to be approved by the Ethics Committee in the hospital. The EC is usually established by Indoriv and their paper work is maintained by them. Before the start of any study their approval is required.

■ Source Documents: Clinical trials is like being a story teller. From the moment a patient enters to when he leaves everything, they do in the hospital from doctor prescriptions, their treatment and medicines have to be recorded.

■ Source Transcription in their medical database: All these source documents and data have to be transcribed in the medical data base for safety monitoring and data analysis which forms the main crux of the study.

JANUARY 2021

SwiftNLift

■ SAE recording: In case of any serious adverse event everything has to be recorded and sent to the sponsor and DCGI within 24 hours.

■ Monitoring Visits and Audits: These are a regular affair. The Sponsor/CRO/DCGI does regular audits and monitoring. The site needs to be prepared with all of these documents continuously.

Standards & SOP Having worked with scores of clients across the world, Indoriv’s processes are matured and compliant with international standards. For each client, it defines the process and documentation standards / SOPs. It includes things like: ■ Drug Storage at the optimum temperature and maintaining a daily log for same using Data Logger.

■ Periodic (6 monthly) calibration of equipment and maintaining of relevant records.

■ Upkeep of infrastructure including AC, Fire

ANANT AGARWAL Founder

Safety, Water Proofing, Lock/Key ■ Signature of stakeholders (e.g., Doctors) on all the relevant documents.

■ Maintaining all master file and trial documents.

■ Medical Archival and storage of all documents.

■ Ethics Committee SOP ■ Clinical Trial Site SOP In future, Indoriv plans to develop and deploy a centralized web based multi-site management software platform to manage its operations. Some of the key audits that it has to face are - DCGI audit, US FDA audit, Internal audits by PHARMA cos conducted proactively and Signature of stakeholders (e.g., Doctors) on all the relevant documents.

JANUARY 2021

SwiftNLift

35

COVID 19 – Statistics, testing and clinical trials What is COVID- 19? How it is spread?

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. It is a contagious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Most people infected with the COVID-19 virus will experience mild to moderate respiratory illness and recover without requiring special treatment. Older people, and those with underlying medical problems like cardiovascular disease, diabetes, chronic respiratory disease, and cancer are more likely to develop serious illness.

of confirmed cases in Asia and has the second-highest number of confirmed cases in the world after the United States with more than 10.3 million reported cases of COVID-19 infection and more than 150,000 deaths as of JANUARY 06, 2021. The per day cases peaked midSeptember in India with over 90,000 cases reported per day and have since come down to below 40,000 in December. In India till the date there were 10,395,938 active Coronavirus Cases out of which 10,016,859 have been recovered and 150,372 had died.

The best way to prevent and slow down transmission is to be well informed about the COVID-19 virus, the disease it causes and how it spreads. Protect yourself and others from infection by washing your hands or using an alcohol-based rub frequently and not touching your face. You have to always use mask to cover your nose and mouth.

In July 2020, India's Ministry of Information and Broadcasting claimed the country's case fatality rate was among the lowest in the world at 2.41% and "steadily declining". By mid-May 2020, six cities accounted for around half of all reported cases in the country – Mumbai, Delhi, Ahmedabad, Chennai, Pune and Kolkata. As of 10 September 2020, Lakshadweep is the only region which has not reported a case. On 10 June, India's recoveries exceeded active cases for the first time. Infection rates started to drop significantly in September, and the number of daily new cases and active cases started to decline rapidly. A Government panel on COVID-19 announced in October that the pandemic had peaked in India, and may come under control by JANUARY 2021.

India has over 30 anti-COVID vaccines in various stages of development and the first of these is expected to be introduced in early 2021.

COVID-19 pandemic in India

Testing of the virus

The COVID-19 virus spreads primarily through droplets of saliva or discharge from the nose when an infected person coughs or sneezes, so it’s important that you also practice respiratory etiquette (for example, by coughing into a flexed elbow).

Prevention

The COVID-19 pandemic in India is part of the worldwide pandemic of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first case of COVID-19 in India, which originated from China, was reported on 30 JANUARY 2020. India currently has the largest number 36

The standard method of testing for presence of SARSCoV-2 is real-time reverse transcription polymerase chain reaction (rRT-PCR), which detects the presence of viral RNA fragments. As this test detects RNA but not infectious virus, its ability to determine duration of JANUARY 2021

SwiftNLift

infectivity of patients is limited. The test is typically done on respiratory samples obtained by a nasopharyngeal swab; however, a nasal swab or sputum sample may also be used. Results are generally available within a few hours to two days. Blood tests can be used, but these require two blood samples taken two weeks apart, and the results have little immediate value. The WHO has published several testing protocols for the disease.

A number of laboratories and companies have developed serological tests, which detect antibodies produced by the body in response to infection.

Clinical trials by various institutions in India The ICMR has selected 12 institutes, including one from Odisha, for clinical trial of the country's first indigenous COVID-19 vaccine. Bhubaneswar-based Institute of Medical Sciences and SUM Hospital under the SOA Deemed to be University has been chosen by the Indian Council for Medical Research (ICMR) for undertaking human clinical trials of India's first coronavirus vaccine.

ICMR has developed the indigenous COVID-19 vaccine (BBV152 COVID vaccine) partnered with Bharat Biotech International Limited (BBIL).

The 12 institutes have been asked by the ICMR to fast track clinical trials of the vaccine as it is being considered as one of the top priority projects which are being monitored at the topmost level of the government.

The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune.

JANUARY 2021

SwiftNLift

ICMR and BBIL are jointly working for the pre-clinical as well as clinical development of this vaccine. BBIL is working expeditiously to meet the target, however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project, the ICMR told the selected institutes.

In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, the selected institutes are strictly advised to fast track all approvals related to the initiation of the clinical trial and ensure that the subject enrolment is initiated.

Serum Institute of India, which is the world's largest vaccine maker by volume, is trying to expand its capacity for manufacturing the vaccine to around 10 crore doses from around 5-6 crore doses now. So far, Serum Institute has signed a bilateral pact for vaccine supply with Bangladesh. And, the Pune-based institute is not planning to sign a pact with other countries because it may not be able to provide vaccines.

Serum Institute is currently conducting the phase-3 trial of Oxford-AstraZeneca's COVID-19 vaccine candidate in India. It is anticipated that Covishield will be one of the first to secure regulatory approval, along with vaccine candidates from US-based Pfizer and Moderna Inc, as scientists across the world try to find a vaccine against novel coronavirus.

Serum Institute has also signed pacts with the Bill and Melinda Gates Foundation and Gavi, the Vaccine Alliance, for the manufacturing and delivery of as many as 20 crore doses of COVID-19 vaccines from Oxford and Novavax.

37

MILAGRO CLINICAL RESEARCH

M

ilagro Clinical Research (MCR) is Mumbai, India based Clinical Research Organization (CRO), committed for the conduct and execution of ethical and high-quality Clinical Trials. It not only conducts the Phase IPhase IV Clinical Trials but has proven the capacities in Biotechnology, Medical device, Nutraceuticals, Cosmetic and academic Clinical Trials. MCR is a proven lead administrant of AYUSH Clinical Trials.

The team of domain knowledge experts, SMEs, experience and qualified professionals adds value to its strengths. Milagro Clinical Research = Ultimate Perfection

Pharmacovigilance Collection, Evaluation, Analysis and Reporting of Safety Information from All Sources Including Spontaneous Reports of Adverse Events of Marketed Drugs.

Top 10 Clinical Trials Service Providers in 2021

■ Data Entry & Validation ■ Electronic Data Entry/ Remote Data Entry Log & tracking ■ Data Cleaning/ Correction Processes

Why Milagro?

■ On time project delivery

Patient Recruitment and Retention

■ Single point of contact

Milagro ensures that site will reach enrolment goals in a timely and cost-effective manner with its customized patient recruitment services.

■ One solution requirements

for

your

all-Clinical

Trial

■ Accurate, comprehensive, and reliable data ■ Cost effective without compromising on quality

Regulatory Affairs Submission Ready: Preparation Ready for Sponsor to complete Full Publishing for Submission to Health Authority.

Clinical Data Management ■ Database design 38

■ Client focused. Customizing project design as per the Client’s need ■ Conveniently located and Easily accessible ■ State of the art infrastructure

Milagro’s Strengths ■ Understand the expectation and emerging needs JANUARY 2021

SwiftNLift

of clients ■ Flexible and adaptive policies accommodate client needs

to

■ Experienced, trained professionals’ team ■ Distinguished investigator’s throughout India

network

■ High performance, uncompromising compliance, ethics, and quality data ■ Capability to conduct Phase II to IV of clinical trial and every therapeutic area ■ Experience of Biotechnology, Cosmetics, Nutraceuticals and AYUSH Clinical Trials

DR. ANJALI SABLE Founder & Director

JANUARY 2021

SwiftNLift

39

SIRO CLINPHARM I

ncorporated in 1996, SIRO Clinpharm Private Limited is a Clinical Research Organisation supporting trials from Phase II to Phase IV and beyond post-launch of products. SIRO offers a range of services, from clinical operations to data services, data analytics and medical writing in compliance with international standards.

The values that define SIRO

SIRO has been an industry pioneer over two decades, sharing an incontestable record of excellence in the pharmaceutical, FMCG and medical device industry.

Its global delivery centre in Thane has a seasoned team of more than 200 professionals hailing from science and medical backgrounds.

At the end of it, we are all scientists. And a scientific bent of mind means that they are always curious.

The world today faces multiple health challenges, and in order to address all those challenges, there’s a constant need for drug development, medical innovations and breakthroughs.

From the time SIRO flagged off operations in 1996 till date, this has been our quest at SIRO – To empower lifesavers through high-quality research.

Considered one of India’s leading clinical research organizations, SIRO has always been passionate about this commitment. SIRO’s research services and solutions help lifesavers save lives. An obsessive zeal breathes life into the impossible.

A never-give-up attitude to work conceives superior life-enhancing healthcare solutions in the speediest time frame possible. Not to forget the wonderful chemistry share with all its clients or the immense respect they have for its dependability. Through it all, SIRO strives to remain ethical, value-driven, competent, progressive and uncompromising on quality standards.

40

■ Authentic True. Honest. By the book. Also are known for being ethical, uncompromisingly so.

■ Curious

■ Open SIRO is great at what it does, but it is always open to possibilities and innovations.

■ Sharp Its work is always subject to exacting standards of quality and excellence.

■ Humane Steadfast to its ethics and values and protecting the interests of the participants.

■ Courageous Willingness to go above and beyond, cross frontiers in its vision to help empower lifesavers.

Driven by a global need for more precise medicine and healthcare, SIRO remains steadfast in its pursuit: to ease the burden of research and innovation on the healthcare industry and to improve the quality of life and to provide a positive and healthy future for all.

JANUARY 2021

SwiftNLift

Top 10 Clinical Trials Service Providers in 2021

JANUARY 2021

SwiftNLift

DR. VATSAL SHAH CEO

41

Clinical Trial Industries in India

What is a clinical Trial?

Clinical trials are scientific studies conducted to find better ways to prevent, screen for, diagnose, or treat disease. These clinical trials may also show which medical approaches work best for certain illnesses or groups of people. Clinical trials produce high-quality data for healthcare decision making.

The purpose of clinical trials is to answer scientific questions. Therefore, these studies follow strict, scientific standards which protect patients and help produce reliable clinical trial results. Clinical trials are one of the final stages of a long and careful research and development process. The process often begins in a laboratory, where scientists first develop and test new ideas.

Every clinical trial has a protocol or study plan that describes what will be done during the clinical trial, how the clinical trial will be conducted, and why each part of the clinical trial is necessary. The protocol or study plan also includes guidelines called eligibility criteria for who can and cannot participate in the clinical trial.

42

Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice that is evidence based.

Unfortunately, the data and reports of various trials are often difficult to find and, in some cases, do not even exist as many trials abandoned or are not published due to "negative" or equivocal results. However, this tendency for availability of only selective information from the myriad clinical trials conducted is not commensurate with the practice of "evidence-based medicine". Today, world over, a need has been felt on the imperative for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data.

And this would be feasible only if all clinical trials conducted are registered in a centralized clinical trials registry. Registration of trials will ensure transparency, accountability and accessibility of clinical trials.

The Clinical Trials Registry- India The Clinical Trials Registry- India (CTRI), hosted at JANUARY 2021

SwiftNLift

the ICMR’s National Institute of Medical Statistics (NIMS), is a free and online public record system for registration of clinical trials being conducted in India that was launched on 20th July 2007 (www.ctri.nic.in).

Initiated as a voluntary measure, since 15th June 2009, trial registration in the CTRI has been made mandatory by the Drugs Controller General (India) (DCGI) (www. cdsco.nic.in). Moreover, Editors of Biomedical Journals of 11 major journals of India declared that only registered trials would be considered for publication.

The mission of the Clinical Trials Registry-India (CTRI) is to encourage all clinical trials conducted in India to be prospectively registered, i.e., before the enrolment of the first participant.

While the mission of the CTRI is to encourage all clinical trials conducted in India to be prospectively registered before the enrolment of the first participant currently, trials where patient recruitment has started or even completed are also being registered. Post-marketing surveillance studies as well as BA/BE trials are also expected to be registered in the CTRI. The vision of the CTRI is to ensure that every clinical trial conducted in the region is prospectively registered with full disclosure of the trial data set items. While this register is meant primarily for trials conducted in India, the CTRI will also accept registration of trials conducted in other countries in the region, which do not have a Primary Registry of its own.

Trials registered in CTRI will be monitored to ensure increasing voluntary disclosure of all items in the register.

These items have been selected in order to: Improve transparency and accountability Improve the internal validity of trials Conform to accepted ethical standards Reporting of all relevant results of registered trials

Fundamentals of clinical trials There are the following four types of clinical trials.

Phase 1 Trials: - These are carried out in a small group of healthy volunteers to test for the safe dose for the drug, its side effects, and pharmacokinetics (absorption, distribution within and excretion from the body).

Phase 2 Trials: - They are conducted to test the efficacy of a drug against the specific disease condition, to gather further information on the adverse effects, or to test the dose of maximum efficacy. These trials involve more JANUARY 2021

SwiftNLift

people than Phase 1 and they are designed to assess the safety and efficacy of an experimental treatment. This phase can last several years.

Phase 3 Trials: - These are much larger trials involving thousands of patients possibly at multiple treatment sites (hospitals). Such trials may test a different route of administration, different dose of the standard drug against the standard regimen, or they may test a new drug against the standard treatment for a given condition.

Phase 4 Trials: - It can also be called as Post marketing Trials. trials take place after a regulatory health authority These are conducted upon the drug having been found effective and after it is licensed for a given clinical condition. The usual objectives are to find out longterm risks or benefits of the drug, to find new clinical indications of the same drug, or to obtain additional information on its side effects and safety. A drug's effectiveness and safety are monitored in large, diverse populations.

Common eligibility criteria may include: • Having a certain type or stage of disease • Having received (or not having received) a certain kind of therapy in the past • Being in a certain age group • Medical history • Current health status Criteria such as these help to reduce the medical differences among people taking part in the clinical trial so that researchers can be more certain that the results are due to the treatment being tested and not to another reason.

It is wrong to assert that human well-being function of clinical trials can only be achieved if there are adequate monetary incentives built in for the researchers and the drug manufacturers for, that such a system has singularly undermined the interests of the patients.

Additionally, there is a need to recognize the power relationships that operate between countries, within countries between different social classes, and between the physicians and patients which have defined the manner in which clinical trials industry has grown in the developing world. These power relationships undermine all the regulations that may be put in place to ensure ethical conduct of clinical trials.

43