Medical Writing for Clinical Trials and Regulatory Submissions

The Medical Writing Expertise to Write Clinical Trial Documents and Marketing Applications for Regulatory Success

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 seasoned team has significant experience preparing clinical documents including protocols, clinical study reports (CSRs), and Investigator’s Brochures.

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

Medical Writing for Clinical Trials & Regulatory Submissions

Veristat provides medical writing support for the full life-cycle of a product’s development, beginning with early-stage development through marketing application and post approval. 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:

Clinical Trial & Program Documentation

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