Role of CRO’s in Medical Innovation and Drug Development Critical medical conditions such as new threats from chronic diseases and their debilitating conditions require quick responses and consistent attempts on a global level. Therefore, when the medical equipment and pharmaceutical biotechnology companies are in need to introduce efficient and effective drugs faster to the market, that is the time when they also need partners who are able to collaborate and assure them effortless development and service delivery. The intrinsic advantages of a diverse and huge target pool for trials, legal and regulatory frameworks, global infrastructure, and a competent IT have assured Indian’s predominance as apt outsourcing destination for medical causes all over the value chain. It is essential to mention here that the CRO’s have played an essential part of the process. Clinical Research Organization, also known as a CRO is a service organization that primarily assists the biotechnology and pharmaceutical industries by outsourcing resource services, mostly domestic on the basis of a contract. The services offered by a CRO can range from preclinical research, biopharmaceutical development to clinical trials management. An eminent branch of study that deserves mention here is the Phase 1 Study that is usually backed up by the experiences of clinical trials. Renowned CRO’s in India provide state-of-the-art architecture that helps in conducting the Phase 1 Studies by volunteers. Some of them include the following:
First-in-human Single Ascending Dose Studies Multiple Ascending Dose Studies New Chemical Entity (NCE) Studies Dose Escalating Studies
Regulatory services and QA too comprise an essential aspect of the service portfolio of popular CRO’s in India, having a dedicated group for audit compliance and regulatory services that is in turn supported by the expertise of regulatory processes and efficient association with numerous regulatory agencies that assures efficiency in approving medical trails and researches. The regulatory services provided comprise the following:
Formulation of regulatory strategies Compilation of the clinical trial application Submission and follow-up of the application Response to regulatory agency queries Procurement of drug import licenses Procurement of NOC for export of biological samples Tracking of applications and approvals Safety Reporting Submission of Clinical Safety Report (CSR) Renewal of Import License
These apart, other innovative service offerings by CRO’s in India would include Quality Assurance, Central Lab, Project Management, Biometrics (consisting of Pharmacokinetic (PK) analysis, Statistical analysis and Medical Writing), Bioanalytical studies and many more.
Critical medical conditions such as new threats from chronic diseases and their debilitating conditions require quick responses and consiste...