Medical Writing

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.