Genelife Clinical Research provides qualitative medical writing service for Phase I to Phase IV Clinical Trials. Our medical writing team has wide experience in writing Protocol for complex early phase clinical trials and Late phase Clinical Trials. We have prepared Clinical study reports (CSR) for USFDA (505(b)(2), DCGI, TGA and BfArM). Genelife Clinical Research CROWith extensive experience, we provide medical writing services as a whole or at any stage of medical writing.

  • Study Design : Designing the study on the basis of input received from sponsor
  • Study Document preparation: Obtaining background information (pre-clinical and earlier phase clinical data) to prepare the Investigator Brochure (IB) for the study product, Protocol, PIS/ICF, Patient Diary & Subject Emergency Card etc.
  • Study Report Preparation and Submission: Preparing Integrated clinical/statistical study report and submitting the study report to the given regulatory body and to the sites for EC submissions.
  • Manuscripts Writing
  • Slide Kits
  • Posters
  • CTR Summary
  • Annual Safety Reports
  • Patient narratives
  • Abstracts
  • Informed consents
  • Risk profile