Medical Writing
- 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
- Reconciliation of Serious Adverse Events
- Protocol Input for Statistical Section
- 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 the preparation of clinical reports. Reports are also generated as per the format of the regulatory agency of the submission country.