Medical Writing 

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 scientific-minded writing 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)
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Regulatory Submission Documents

  • Clinical & Non-Clinical Summaries (Module 2)
  • Integrated Summaries of Efficacy and Safety (Module 5)
  • Responses to Agency reviewers
  • Regulatory Briefing documents for Agency meetings, including:
    • Pre-IND, End of Phase 1,  End of Phase 2/3, Pre-NDA  and  Advisory Committee
  • Orphan Drug Designation Applications
  • Risk Management Plans

Medical Writing Support for Thought Leadership

Medical Writing Expertise

Additionally, our medical writers offer medical writing support to share clinical trial data and results in many formats including:

  • Slide presentations for industry conferences and regulatory agency meetings
  • Abstracts & posters for professional meetings
  • Clinical trial product registration and results postings on clinicaltrials.gov and EudraCT
  • White papers, publications, and manuscripts
  • Literature reviews and searches
  • Style guide creation

Learn More with These Resources

Case Study
Stem Cell Therapy for Stroke Patients

A client engaged the Veristat team in a Phase II study of intracerebral stem cell injection in patients following an ischemic stroke. The goal was to look at limb ...

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Case Study
Medical Writing Partnership - IND to NDA

Learn how the Veristat medical writing team partnered with a sponsor and supported their entire rare oncology program from IND to NDA.

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Infographic
7 Habits of Highly Successful Medical Writers

We have an expert team of medical writers here at Veristat. They can handle it all from clinical trial and program documentation to regulatory submission ...

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