Medical Writing

Services offered include:

• Clinical Trial Document preparation:
  • Preparation of Protocol for clinical trial (Drug, vaccine and medical device), BA/BE studies and epidemiological studies. (as per ICH GCP or Schedule Y requirements)
  • Investigator’s Brochure
  • Informed Consent Document
  • Designing case record form.
• Study design, Statistical analysis and report generation:
  • Designing the study, estimating sample size, determining statistical tests and generation of randomization list.  Performing interim and final analysis for the trial data and generation of statistical report.
• Preparing training manual:
  • Preparation of training manual on the following topics: New Drug Development, Clinical trial regulations and guidelines, Clinical Trial Operations, Clinical Data Management, Medical Writing, Biostatistics and Pharmacovigilance.
• Preparation of SOPs, Logs and Templates:
  • Preparation of Standard Operating Procedures,  Logs and Templates for Clinical Trial Operation and Clinical Data Management.