globeELIXIR Clinicals

Medical Writing

Medical Writing

globeELIXIR medical writing domain is well equipped with professionals having strong academics besides having valuable scientific experience in various therapeutic areas; help to compile, organize, write, edit and produce a wide range of medical and scientific documentation essential to deliver the quality and timeliness required to support the product development efforts.

globeELIXIR clients can safely bank on our writers at any stage in their product development lifecycle from clinical development plan and investigator brochures to regulatory submission and licensing maintenance documents. Having in-house expertise from to pharmacovigilance, we are capable to work on study reports, patient narratives, DSMB updates, labelling or other documents involving study data. Our unique medical writing offerings are in strict adherence with ICH guidelines and similar regulatory requirements.

The Medical Writing services at globeELIXIR Clinicals is proficient in:

  • Clinical development plans
  • Abstracts, manuscripts and journal articles
  • Investigator brochures and annual updates
  • Informed consent forms
  • Protocols
  • Clinical study reports
  • Clinical sections of Common Technical Documents
  • Clinical sections of New Drug Applications
  • Periodic Safety Update Reports and other pharmaco-vigilance documents
  • Pre-FDA meeting briefing documents
  • Response to clinical hold orders
  • Preclinical study reports, expert reports and summaries
  • Data Safety Monitoring Board manuals
  • Written and tabular summaries

Bio-Analytical Reporting

  • Method Validation Reports
  • Bio analytical Reports
  • ISR Reports
  • Submission-ready Documentation
  • Dispatch & Archival
  • Benefit and Risk assessment reports apart from medical and scientific literature reviews