Medical Writing Services
Genelife Clinical Research has a stellar Medical Writing Team with extensive experience crafting the precise language needed for complex early and late-phase clinical trials. This dynamic team has mastered the art of preparing Clinical Study Reports (CSRs) meeting the rigorous standards of USFDA (505(b)(2)), DCGI, TGA, and BfArM — positioning us as the preferred CRO in India for medical writing.
Medical Writing Service Portfolio
Study Documents
Investigator Brochures (IB), Protocols, Patient Information Sheets (PIS), Informed Consent Forms (ICF), Patient Diaries, and Emergency Cards — prepared to ICH E6 and agency-specific standards.
Clinical Study Reports (CSRs)
Comprehensive integrated clinical and statistical study reports prepared to ICH E3 standards for USFDA, DCGI, TGA, and BfArM submissions — covering all study phases.
Regulatory Submissions
CTD Module narratives, briefing documents, response to regulatory agency queries, and complete eCTD documentation for global drug approval submissions.
Periodic Safety Reports
Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), Annual Reports, and other periodic regulatory safety reporting obligations.
Publication Support
Scientific manuscripts for peer-reviewed journals, conference presentations, posters, and abstracts — supporting the dissemination of clinical research findings.
Study Design Support
Collaborating with sponsors to design scientifically sound clinical trials — including protocol design, endpoint selection, and statistical analysis plan development.
Regulatory Standards: All medical writing at Genelife adheres to ICH E3, ICH E6, ICH M4 (CTD), and agency-specific guidelines — ensuring documents are submission-ready for CDSCO, FDA, EMA, TGA, and other global regulatory authorities.