Advanced Certified Program in Clinical Research & Operations Management

Advanced Certified Program in Clinical Research & Operations Management

The pharmaceutical and biotech industry is experiencing a sea change worldwide with more impetus on innovation and personalized medicine. The business models are maturing to the next level of niche busters and towards a coexistence of novel and the age old blockbuster strategies.

With the economic drift and emerging economies like India, China, Brazil and Russia, the pharmaceutical and biotech industry is shifting research and development towards these regions especially in the phases of clinical development. Further, indigenous pharmaceutical and biotech companies in these regions are increasing their R&D efforts both for innovative molecules as well as the generic market.

Consequent to this scenario, a large number of clinical research organizations have recently developed which include a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management, clinical research consultancies, KPOs etc. This has created a demand for skilled workforce in the clinical research industry.

This course will provide extensive training in the niche domain of clinical research. It incorporates end-to-end theoretical & practical training.

Following Course Content will be covered during the training:

The focus of the lectures is mainly on:

• Drug discovery and development
• Preclinical studies
• Basics of Clinical Trials & Clinical Research
• Terminology & Definitions in Clinical Trials
• Types and Phases of Clinical Trials
• Good Clinical Practices (GCP)
• BA/BE Studies
• Research Methodology & Clinical Trial Design
• Clinical Trial Regulatory Affairs
• Preparations & Planning for Clinical Trials
• Essential Documentation in Clinical Trials & Regulatory Submissions
• Clinical Trial Operations and Monitoring
• Responsibilities of Clinical Research Professionals
• 21 CFR PART 11
• Informed Consent Document
• Schedule Y
• Protocol Development
• Intellectual property Rights (IPR) and Patent Laws
• SOP development for Clinical Trial Operations
• Compliance, Auditing & Quality Control in Clinical Research