Medical Writing Services

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Expert Medical Writing for Impactful Drug Development Documentation

The success of drug development programmes depends on the accuracy, readability, and reviewer-friendliness of the documentation. Our team of seasoned medical writers, all of whom have a scientific or medical background, are at your disposal. With a broad experience in the development of documents for different products and therapeutic fields, we offer professional medical writing services to assist you in delivering clear and well-structured documents that are fit-for-purpose. In addition, our medical writers are embedded in the Venn organization, surrounded by nonclinical, clinical, CMC, and regulatory consultants, which allows us to combine state-of-the-art knowledge with efficient medical writing support.. Therefore, having a medical writing consultant dedicated to your project will enhance the quality of documents as well as the speed of work and is essential to meeting the targeted timelines.

Our medical writing services consist of a highly qualified team to support you in achieving your goals, which is demonstrated by the case study below.

Recently, Venn Life Sciences was responsible for the reporting of a first-in-human trial while simultaneously preparing several documents necessary for the opening of an investigational new drug (IND) application for a biotech company. These documents included the investigator’s brochure and the clinical modules of the CTD. In doing so, the medical writing team had to assure consistency and alignment across the documents while adhering to the sponsor’s timelines. This required close collaboration with contributing authors and strict planning, as some documents could only be written once others were completed. We delivered all documents to the satisfaction of the sponsor and according to the requested timelines, and the IND was submitted as planned.

Venn Life Sciences can support you in:

Clinical Documents

  • Clinical trial outline/synopsis, protocol, and amendment
  • Investigators’ brochure
  • Clinical trial reports
  • Narratives
  • Pharmacokinetic reports

Regulatory Documents


Pharmacovigilance Documents

  • Development Safety Update Reports (DSURs)
  • Intermediate periodic safety reports

General

  • Scientific publications
  • Editing & formatting

Learn more about Medical Writing Services

Ready to see how Venn Life Sciences could speed up your drug development program?
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