Medical Services

Medical Oversight

  • Medical Overview of the clinical trials
  • Training of Study Teams and sites
  • SEC meetings at DCGI
  • On site monitoring
  • Central Monitoring – identifying risks and its mitigation

Medical Writing

  • Feasibility survey reports, disease demographics from India and other territories
  • Protocol
  • Clinical study report
  • Informed consent documents
  • Subject diaries
  • Case report forms
  • Patient support aids

Regulatory Writing

  • Investigational Medical Product Dossier (IMPD)
  • Investigator Brochure (IB)
  • Clinical & non clinical sections of the Common Technical Document (CTD) including summaries and overviews for EU or US Regulatory Authorities
  • IND, 505(b)(2) and pre-EMEA meeting briefing packages
  • Product Monographs
  • Executive Summary for DCGI submission and SEC presentation
  • Web synopses (, EU clinical register, CTRI etc)

Scientific Writing

  • Publication Support
    • Peer-reviewed Publications (from publication planning to journal/ congress submissions)
    • Abstracts, posters (content and layout), slide-sets, conference coverage
  • Medico Marketing Support
    • Flash cards, Detail aids, Leave Behind Leaflets (LBLs), Brand Lexicon
    • Newsletters
    • Drug Brochures/Product Monographs
    • Booklets/Compendiums
    • Patient educational materials
    • CME Slides/Abstracts
    • Training Documents
    • Online Learning/ Training modules
    • Patient Materials