At ClinActis, our team of medical writers is dedicated to providing clear and concise communication throughout the entire clinical development and commercialization process. From protocol development to clinical study reports and regulatory documents, we ensure that all materials are well-written and easy to understand for sites, investigators, and regulatory agencies. Our medical writers specialize in preparing a wide range of documents, including:

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• 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