Medical Writing For Clinical Trials

Medical writers are critical to the communication process of outlining the goals, strategies, analysis, and medical understanding of a clinical trial/program to patients, sites, sponsors, and regulatory agencies. Our scientific-minded writing team has significant experience preparing clinical documents, including protocols, clinical study reports (CSRs), and Investigator’s Brochures.

Veristat excels in writing regulatory documents to support drug, biologic, device, and diagnostic marketing applications to regulatory agencies worldwide. We understand the complexities of writing in a highly regulated environment and the challenges of the varied requirements of different regulatory agencies.

Medical Writing for Clinical Trial and Regulatory Submission Documentation

Veristat provides medical writing support for the entire life cycle of a product’s development, beginning with early-stage development through regulatory registration and commercialization. We offer rapid turnaround to meet tight timelines, and flexible, efficient processes for any project, large or small. Using in-house or sponsor-supplied document templates, we apply best practices for content, format, and style to meet global technical and regulatory requirements. Our expert medical writing team supports the development of the following types of documentation:

Writing for Clinical Trial Documents

• Protocol Synopsis, Protocols, and Amendments
• Informed Consent Forms
• Clinical Study Reports (CSRs)
• Patient Narratives
• Safety Narratives
• Clinical Development Plans
• Investigator Brochure and Patient Information Leaflets
• Lay Summaries
• Annual reports
  • Periodic safety update reports (PSURs)
  • Development safety update reports (DSURs)
  • Periodic benefit-risk evaluation reports (PBRERs)

Writing for Regulatory Submission Documents

• Clinical Trial Applications in eCTD format (IND, CTA, and IMPD)
• Marketing Applications in eCTD format (NDA/BLS, MAA, NDS, etc.)
• Integrated Summaries of Safety & Efficacy (ISS & ISE)
• Responses to questions from Regulatory Authorities and Agency reviewers
• Regulatory Briefing documents for Agency meetings
• Special Designation applications, including Orphan Drug Designation Applications (ODDs) and PIP/PSP
• Risk Management Plans
• Individual Case Safety Reports (ICSRs) and Aggregate Reports
• Core Value Dossiers

Do you have medical writing, regulatory writing, or medical communications needs? Let's Talk.