Medical Writing

Quality and clarity from an exceptional team of regulatory medical writing experts.

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Let’s be very clear

Quality and clarity are vital when producing any regulatory document. Partnering with experienced medical writers can help accelerate the approval process and avoid costly delays. At Premier Research, our dedicated medical writers work as a true extension of your team.

Averaging 20 years of industry experience, our writers share a passion for excellence. All have strong analytical communication skills and expertise across multiple therapeutic areas, including analgesia, oncology, pediatrics, cardiology, neurology, dermatology, gastroenterology, endocrinology, immunology, psychiatry, ophthalmology, rare diseases, rheumatology, and medical devices.

Our writers have thorough knowledge of U.S. Food and Drug Administration and European Medicines Agency guidelines. In addition, each has extensive experience in the development of study protocols, investigator brochures, patient-facing documents, clinical study reports (CSRs), patient narratives, and other regulatory submission documents. We also keep our finger on the pulse of industry standards and employ the principles of CORE Reference, focused authoring, and TransCelerate’s common document templates.

We specialize in:
  • Clinical protocols and amendments
  • Clinical study reports
  • Participant information sheets
  • Informed consent forms
  • Age-appropriate assent forms
  • Participant narratives for CSRs
  • Investigator brochures
Additional services include:
  • Marketing applications and associated documents, for example:
    • Clinical components of the Common Technical Document
      • Clinical Overview (Module 5)
      • Summary of Clinical Efficacy (Module 2.7.3)
      • Summary of Clinical Safety (Module 2.7.4)
    • Integrated Summaries of Efficacy and Safety (U.S. submissions)
    • Investigational new drug applications
    • Orphan drug designation applications
  • Device applications
    • Investigational device exemptions
    • Premarket applications
  • Pharmacy manuals
  • Clinical evaluation reports
  • Regulatory agency briefing documents
  • Pediatric study plans (U.S.) and pediatric investigation plans (EU)
  • Trial registration, updates, and results reporting on clinicaltrials.gov and clinicaltrialsregister.eu
  • Lay summaries
  • Manuscripts, posters, and data presentations
  • Safety reports
  • Risk evaluation, mitigation, and management plans

When you engage with Premier Research medical writers, you can count on timely, high-quality deliverables from a team recognized for its exemplary work and extraordinary levels of customer satisfaction.

Premier Medical Writing Experts

Shari Medendorp

Shari Medendorp

SVP, Biometrics
Emily Stube

Emily Stube

Senior Director, Medical Writing

Get more information

Ready to get started? So are we. Drop us a line to learn more about how we can help.

What Our Customers Are Saying

“You really did a great job. What struck me was how you were able to wrap your head around the science and truly synthesize the data to produce a clear, well-written document.”

“This is an extremely well-written CSR – very clear and very concise. We want to thank you for all of your efforts on this document.”

“You folks – more than any other vendor I’ve worked with in recent memory – have been most accommodative & supportive and I want you to know I’m deeply grateful!”

“I would like to thank you and the entire Premier team for being cooperative and very flexible throughout the protocol development process. We appreciate very much that the [documents] are finalized for IND submission and acknowledge that this was a very hard target to reach.”

“On behalf of the entire team, we would like to thank each one of you for the incredible effort you have put forth in getting all of the necessary documents completed! Because of your expertise and dedication, we were able to finalize and submit all necessary documents required for contract compliance to date.”

“This was a smooth, well organized ICF review. Great work all!”

“We are also over the moon that you have managed this! THANK YOU so much for pulling out all of the stops on this.”

Related Services

Medical writing is part of a wide range of integrated offerings that include biostatistics, regulatory consulting, and safety and pharmacovigilance. Follow the links below to learn more about how clients have benefited from our specialized expertise.

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