Medical Writing

SCiAN’s medical writing team draws on more than 15 years of extensive industry knowledge and therapeutic expertise to effectively meet our Sponsors’ requirements.  SCiAN’s Medical Writers work collaboratively with internal and external experts in regulatory affairs, biostatistics, clinical data management, and other departments to produce clinical writing deliverables that reflect the clinical experience and integrity of the entire organization.  Our vast experience level helps us deliver a portfolio of medical writing services to address the needs of every clinical research project including:

• Drug development plans
• Investigator brochures
• Protocols and amendments
• Informed consents and assents
• Investigational new drug applications
• FDA pre-meeting packages
• Clinical study reports (Phase I, II, III, and IV)
• Safety narratives
• Data and safety monitoring board (DSMB) reports
• Interim data summaries
• Abstracts and manuscripts
• Integrated Summaries of Safety (ISSs)
• Integrated Summaries of Efficacy (ISEs)