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Innovating Solutions for Pharma Research & Development

LOTUS

Centre of Excellence for Clinical Research

...to be the most admired clinical research organization from India


About Lotus

Lotus Labs Pvt Limited is a Clinical Research Organization based in Bangalore, operating since February 2001, engaged in the conduct of Bioequivalence, Phase I studies and Clinical Trials. Lotus has completed more than 1400 bio studies to date and several Phase I and Phase III trials. Lotus operates from 4 sites for its clinical operations (3 facilities in Bangalore and 1 in Chennai) with combined bed strength of 360. The centralized BIO ANALYTICAL lab located in Bangalore operates in more than 20,000 sq. ft. area with State-of-the-art equipments like LCMS/MS & HPLC. Lotus has 14 LCMS/MS instruments (13 from AB Sciex including 5 API 4000 and API 5500), one from Waters and 4 HPLC. More than 250 methods have been developed and validated. Lotus has a dedicated team to develop and validate new methods as required. We have a state-of-the-art, fully equipped Phase I unit in our Clinical Facility which is located inside the campus of St. John's National Academy of Health Sciences, Bangalore for conducting Phase I trials. St. John's is a 1200 bed hospital covering most of the important branches of medicine like Pediatrics, Cardiology, Oncology, Obstetrics etc. St. Johns Hospital its among the top 10 hospitals in India.

Lotus has a dedicated Clinical Development team for the conduct of Clinical Trials. The 30 strong team has been involved with submission studies for major regulatory bodies. The team offers end-to-end services for the clients. The Central Lab, located in Bangalore is CAP and NABL accredited. It offers the services for the examination of hematology, biochemistry, serology, urine analysis & ECG for screening and safety analysis of healthy volunteers and patients. It has won international accreditation from CAP and is now serving as Central Lab for Global Clinical Trials. Lotus has a data base of more than 35,000 healthy adult volunteers. Lotus employs more than 450 trained and skilled technical staff. Lotus has set up a central archival facility in Bangalore where all study documents are archived. The facility is spread over an area of 7350 sq.ft. The facility is well protected for any eventualities against fire and other natural calamities.


Services Offered Lotus offers an array of services to cater the pharmaceutical and biotech organizations.

These services involve: Study Design ? Protocol Writing ?

Pharmacokinetics ? (Healthy & patient population)

Human Bioavailability studies ?

Statistical services ?

Bio equivalence studies ?

Medical writing ?

Food effect studies ?

Special population studies ? Hepatic & Renal impairment etc.

First in man studies ? Phase I - Phase III clinical trials ?

Biogenerics/ Biosimilars ? Regulatory Services ?

Bioanalysis ? (>250 methods validated)

Pharmacy Services ?

Data management ?

Central Lab Services ?


Inspections Lotus has successfully completed more than 40 audits from Indian & International Regulatory Agencies Drugs Controller General of India ?

AGES, Austria ?

USFDA ?

ANVISA, Brazil ?

EMEA ?

MCC, South Africa ?

AFSSAPS, France ?

MOH, Turkey ?

WHO ?

MCC, Zimbabwe ?

Lotus has been approved for submission of studies to Sudan and Israel.

Recruitment and Volunteer Database The Recruitment Team and the Screening team manage the recruitment of the volunteers and maintain a database of all the volunteers registered and participated in the studies at Lotus. Screening and Enrolment of the volunteers is done through “biometric� finger print system that registers the basic information of the volunteer incase he/she had participated in studies earlier at Lotus Labs. After registration, all the volunteers are provided with the ID card that is to be presented by them every time they wish to participate in a study.

Ample explanation and time for signing the consent form in the vernacular as well as English is done to make sure of the volunteers right to information.

Currently Lotus maintains a population of: ? More than 35,000 normal healthy adult active volunteers in the database ? Non smokers ? Special population associated with renal & hepatic impairment, hypogonadal, obese & geriatric volunteers ? Female population including postmenopausal women


Bioequivalence and Bioavailability Studies Lotus has experience of handling more than 1400 bio studies for different indications including First in Man studies, Drug Drug Interaction, Food Effect Studies, complex studies, studies involving long days of housing, conducting studies in female volunteers and pediatric population. The studies involving patients and special populations are conducted in liaison with the specialists Investigators and GP’s. The availability and our good relationship with the hospitals enable better recruitment, compliance and conduct of these studies. Each of the Clinics have separate area for Screening, Change Room with Lockers, Housing, Entertainment, Phlebotomy, Sample Separation, Storage and Dining.

The experienced and friendly staff makes sure to maintain the safety and well being of the volunteers. There is a 24 Hrs Ambulance with a driver dedicated to all the clinics to manage any SAE. All the Lotus facilities have the advantage of being located near or in the vicinity of Super Specialty Hospitals and the maximum time to reach the nearby hospitals is not more than 5 minutes.


Central Lab Services Central Lab at Lotus is CAP (College of American Pathologists) and NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited in accordance with the international standards ISO 15189, to support the in house requirement as well as to cater as a stand alone service to the Pharmaceutical requirements. Located in Lotus House, the lab is spread over 1400 sq. ft and the infrastructure includes state-of-the-art equipment and experienced staff.

The services include the analysis of samples for the following parameters: Hematology, Coagulation, Biochemistry, Serology Clinical Pathology, Hormone Assays, Specialized Tests for clinical Trials. LIS (Laboratory Information System) ensures the security and integrity for online data transfer.

Biometrics Lotus has a full-fledged team for Protocol Writing, Report Writing and Statistical Analysis for Statistical analysis WinNonlin Version 5.0.1 is used, for SAS version 9.2 and SDMS (scientific Data Management System) 7.0 is used to manage the data generated. Lotus has experience of submitting the study reports in format as per the regulatory submissions i.e; for US (ICHE3 with eCTD format), Brazil (ANIVSA format), European (ICHE3), Canada, TGA and Swiss Regulatory specific formats. MedXview software is used for direct eCTD submission.

Regulatory Services Lotus has a dedicated team for regulatory and audit compliance to give the best solutions to our client’s requirement. The in-depth knowledge of local regulatory procedures and effective liaison with the regulatory agency, our regulatory team ensures efficiency in the clinical trial approval process. The range of services provided is as follows: Formulating regulatory strategies ? Compiling the clinical trial application ? Submitting and following-up the ? application Responding to regulatory agency ? queries Obtaining drug importation licenses ?

Obtaining NOC for export of ? biological samples Tracking of applications and approvals ? Safety Reporting ? Submission of Clinical Safety Report ? (CSR) Renewal of Import License ?


Phase 1- First in Man Studies A state-of-the-art, fully equipped Phase I unit is located inside the campus of St. John's Medical College and Research Institute, Bangalore, for conducting its Phase I - first in man studies. St. John's is a 1200 bed hospital and research institute. It is ranked among the top medical colleges in India.

Lotus' Phase I Facility 12 fully equipped beds

Equipment: Central Cardiac Monitoring Unit Defibrillator Central Nursing station Oxygen & suction lines Crash Cart

Lotus has conducted several Phase I - first in man studies ? Single Ascending Dose Studies ? Multiple Ascending Dose Studies ?

Ideal facility for conducting Phase I - First in Man Studies situated inside campus of a tertiary hospital.

Drug-Drug Interaction Studies ? Food Effect Studies ? Biogenerics Studies including Vaccines, ? Immunoglobulin & Erythropoietin Renal impairment studies ? Clinical end point studies for USFDA ? submission involving more than 84 sites & 2400 patients


Other Capabilities within Phase I / II ? Study design ? Protocol preparation Biostatistics ? Regulatory submissions ? Medical writing ? Monitoring services ? Medical & Safety Monitoring ?

Therapeutic Areas Phase I / II Oncology ? Vaccines ? Cardiovascular ? Respiratory ? Dermatology ?


Clinical Development Services ? Phases: I to III Clinical Trials including clinical end point studies

Comprehensive range of services to global pharmaceutical and biotech companies for managing Phase l to Phase lll clinical trials within the Indian sub-continent

230 sites (India, Bangladesh) ? Over 7400 subjects ? FDA submission studies ?

Lotus offers following benefits Excellent infrastructure to manage ? Clinical Trials Team with rich & varied professional ? experience Rapid recruitment rate ? Expertise in various therapeutic ? segments

State-of-the-Art Phase I Facility inside the ? campus of St. John's National Academy of Health Sciences, a leading multi-speciality hospital in Bangalore Access to patients in major ? therapeutic segments Fast turn around time ?

Feasibility Assessment Study Monitoring

Statistical Services

Regulatory Affairs

Service Offerings

Project Management

Site and Supplies Management

Central Lab Medical Writing


Clinical Facilities LOTUS HOUSE Corporate Office Bio Analytical Facility: 14 LCMS/MS, 4 HPLC More than 250 methods developed and validated. Clinical Facility: 74 Beds (3 wards) Central Laboratory Services (CAP & NABL accredited) Total area: 60,000 sq.ft St. John's Clinical Facility: Total Area: 25,000 sq. ft. Clinical Facility: 84 Beds (3 wards) State-of-the-Art Phase I Facility - 12 Beds Located in a separate building inside the campus of St. John's National Academy of Health Sciences, Bangalore Chennai Clinical Facility: Total Area: 11,000 sq.ft. Clinical Facility: 80 Beds (2 wards)

Jakkur Clinical Facility: Total Area: 30,000 sq.ft. Central Facility: 120 Beds (3 wards)

Key Contacts

LOTUS

Centre of Excellence for Clinical Research LOTUS LABS PRIVATE LIMITED Lotus House No. 07, Jasma Bhavan Road, Millers Tank Bed Area, Opp. Gurunanak Bhavan, Vasanthanagar, Bangalore - 560 052. INDIA Ph Nos.: +91-80-22370912/13/14/15 Fax No.: +91-80-22370911

P. Prasad Rao Sr. Manager - Business Development Email: prasad_rao@lotuslabs.com Tel: +91 080 65738922 Mob: +91 9945158884 Arvind Koul Assistant Manager Business Development Email: arvind_k@lotuslabs.com Mob: +91 9740799778 info@lotuslabs.com www.lotuslabs.com

LL/CB/0911/GDU

Dr. Yati Chugh Managing Director Email: ychugh@lotuslabs.com Tel: +91 080 65658452


Innovating Solutions for Pharma Research & Development