- About Us
- CLINICAL STUDY SUPPORT SERVICES
Department of Biotechnology
Ministry of Science & Technology
Government of India
Medical Affairs and Medical Writing
Medical Writing & Medical Affairs
Medical Writing & Medical Affairs department at CDSA aims to work coherently and meticulously with Investigators/SMEs to deliver timely, accurate and superior quality documents meeting the ethical, regulatory and clinical research standards. We are more than willing to support and work towards developing high quality clinical research for studies while meeting deadlines and client specific requirements.
We look forward to work as a team to reach our study specific goals and objectives to add value and knowledge to the clinical research study as a whole.
Our services include:
· Review of Clinical Trial Documents
· Project / Therapeutic Area Training
· Constitution and Coordination of Data Safety Monitoring Board (DSMB)
· To ensure subject safety is met at all times throughout the research
· Project-specific safety management Plan
· Handling medical queries from sites or ECs regarding appropriate interpretation and application of the study protocol
· Medical review of data listings and review of medical coding data
· AE and SAE logging, tracking, MedDRA and WHO-DD coding, individual case safety reports, and development safety update reports
· Integrate pertinent information from statistical analyses into clinical study reports.
· Deliver all documentation in electronic formats, according to Standard Operating Procedures, report templates, and preferred writing style.
· Grant Writing & Study Protocol writing
· Scientific Report Writing and Clinical study reports
· Clinical sections of Common Technical Document (CTD)
· Abstracts and manuscripts
· Designing an Investigator Brochure and annual updates
· Designing Informed Consent Form and Patient Information Sheet (PIS)