Medical Writing 

Quality medical writing of clinical trial documents, safety updates, 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 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 varied requirements of different regulatory agencies.

Medical Writing for Clinical Trials & Marketing Applications

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)

OUR MEDICAL WRITERS HAVE
Proven Expertise and Experience


Written study documents for
>800 Clinical Trials


Written modules for
>80 Marketing Applications

(NDAs, MAAs, NDSs, jNDAs, BLAs)


 

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

Fact Sheet

Marketing Application Preparation Survival Guide: Data ...

Learn how to strategically migrate and produce clinical trial data outputs in submission-ready format to reduce timelines without sacrificing data quality.

Download

Newsletter

The Rapid Pace of Regulatory Change

Read our June 2021 of edition of our Newsletter, Voyager, which provides insights on the value a Veristat partnership delivers to overcome the regulatory hurdles that ...

Read

Case Study

Medical Writing of Multiple Marketing Applications At the ...

A mid-size pharmaceutical company and its development partner, a small biotechnology company engaged Veristat to complete the medical writing for their product’s Marketing ...

Download
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