Medical Oversight
• Medical Overview of the clinical trials – Eligibility and Data review
• Training of Study Teams and sites
• Prepare presentations and attend meetings at DCGI and other regulatory agencies
• On-site monitoring
• Perform data analysis to identify patterns and trends
• Feasibility studies & reports, disease demographics from India and other regions
Medical Writing
• Protocol
• Clinical study report
• Informed consent document
• Assent form
• Subject diary
• Patient support aids (Thank you letter, Participant ID card, Study advertisement material, etc.)
Regulatory Writing
• Investigator’s Brochure (IB)
• Clinical Development Plan
• Clinical & non-clinical sections of the Common Technical Document (CTD) including summaries and overviews for EMA and other Regulatory Authorities
• IND, 505(b)(2) and pre-EMA meeting briefing packages
• Executive Summary for DCGI submission
• Web synopses (Clintrial.gov, EU clinical register, CTRI, etc.)
• Publication Support
- Peer-reviewed Publications (from publication planning, and manuscript writing to journal/ congress submissions)
- Abstracts, posters (content and layout), slide sets, conference coverage, Brand Lexicon
• Medico Marketing Support
- Flashcards, Detail aids, Leave Behind Leaflets (LBLs)
- Newsletters
- Drug Brochures/Product Monographs
- Booklets/Compendiums
- Patient educational materials
- CME Slides/Abstracts
- Training Documents
- Online Learning/ Training modules
