An experienced team of regulatory medical writers plays a pivotal rule in the success of a clinical trial. CSOFT’s teams bring a deep understanding of different document types, style guides, regulatory requirements and therapeutic area expertise, complemented by expertise assimilating and presenting complex data in a concise, accurate manner.
We also specialize in presenting this complex data in the simple, lucid terms required for lay summaries in compliance with the EU Clinical Trials Regulation. Our core translation expertise supports the rapid translation of these documents into all requisite local languages.
- Clinical Trial Protocols
- Investigators’ Brochures
- ICFs and PILs
- Clinical Study Reports (full, abbreviated and synoptic CSRs)
- Clinical Overviews
- Clinical Summaries
- Lay language summaries