From protocol development to clinical study reports and regulatory documents, ClinActis’ medical writers ensure clearly written communications for sites, investigators and regulatory agencies throughout the product development and commercialization process. Among the types of documents our medical writers prepare are:

• Clinical Documents

• Clinical Protocol, Protocol Synopsis and Protocol Amendments

• Investigator Brochures

• Interim Clinical Study Reports (CSRs)

• Final CSRs

• Medical Monitoring and Patient Safety Documents

• SAE Reports with Narratives

• Annual Safety Reports

• Regulatory Documents

• INDs, NDAs

• PMAs, IDEs, 510(k)s

• Annual reports (IND, NDA, orphan drug, etc.)

• Periodic safety update reports

• Module 2 and Module 5 summaries

• Non-clinical study reports

• Agency Cover Letters and Communications

• Briefing Documents

• Agency Response Documents

• Product Labeling

• Requests for Meetings