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.