Medical Writing

Medical writing services are focused on preparing clear, concise, and high-quality documents, easy to read for regulatory approval, trial participants, investigators, and co-coordinators. The specialty document service includes:
Investigator’s Brochure
Informed Consent Document
Patient Information Leaflets
Safety Data Reports
Regulatory Submissions
Clinical study protocol & protocol amendments
Clinical study synopsis
Case Report Forms (CRF) Design Development
Database Design & Development
Data Entry & Data Validation
Query Management
Reconciliation of Serious Adverse Events
Protocol Input for Statistical Section
Sample Size Calculation, Randomization & Blinding
SAS Coding, Statistical Analysis & Report Generation
Consent documents (with translations in various Indian languages as required)
Clinical study reports (as per ICH-E3)
BioSRL clinical section mainly follows ICH-E3 Guidelines (Structure and Content of Clinical Study Reports) for preparation of clinical reports. Reports are also generated as per the format of regulatory agency of submission country.