Medical Servies

Medical Services

The Medical Services team is integral to Cliantha’s success. The services include medical writing, regulatory writing, scientific writing, patient narratives, investigators brochures, Medical Monitoring, Safety reporting, Feasibility studies, discussion with KOLs and other documents involving study data.

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

Regulatory Inspections

Goverment of India Facilities inspected & approved by Drugs Controller General of India
Last inspection in Nov 2015 by
Austria (2 times)
Inspected facility in Nov 2006 by
Inspection facility in jan 2009 by
Last inspection in March 2017 by
USFDA (17 times)
Last inspection in April 2017 by
UK MHRA (2 times)
Last inspection in March 2013 by
WHO (3 times)
Inspected facility in July 2013 by
Thai MOH
Last inspected by Ministry of Health of Turkey in April 2013
Inspected facility in April 2011 by