Medical Writing

CDSA has been undertaking medical writing for regulatory clinical trials conducted in public health domain, ranging from dose-range finding studies to post marketing surveillance studies. We have provided support in protocol development; designing ‘Investigator Brochure’; developing informed consent documents (PIS and ICF), preparing risk/benefit assessment reports and clinical study reports that integrate information extracted, observed and recorded by the clinical operations, project management, quality monitoring and clinical data management teams. All documents should comply with CDSCO – GCP and other applicable regulatory & ethical guidelines for each phase of the clinical trial or clinical research study.

CDSA supports investigators, academic institutes and researchers for review of protocols and other documents for compliance with regulatory and other requirements for submission to licensing authorities as well as to Ethics Committees.