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 (Clintrial.gov, 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