Medical Services
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
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.)
