Medical Writing

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

Let’s be very clear

Overview

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.

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.

Services

  • Regulatory Medical Writing Services
    • Regulatory/health authority submission documents for the FDA and EMA
    • Regulatory review – consistency of message, regulatory commitments
    • Clinical documents – support for labeling
    • Document quality control – data integrity
    • Manuscripts, posters, and data presentations
  • Clinical Document Services
    • Protocols
    • Protocol amendments
    • Investigator brochures
    • Clinical study reports (CSRs)
    • Annual reports
    • Participant information sheets
    • Informed consent forms
    • Age-appropriate assent forms
    • Participant narratives
    • Executive summaries
  • Regulatory Document Services
    • Investigational new drug (IND), new drug application (NDA), and market authorization application (MAA)
    • Orphan drug designation application
    • Device application
    • Pharmacy manuals
    • Clinical evaluation reports
    • Regulatory agency briefing documents
    • Safety reports
    • Risk evaluation, mitigation, and management plans
    • Pre-IND meetings
    • Development safety update reports
    • Regulatory responses
    • Pediatric study plans (US) and pediatric investigation plans (EU)
    • Integrated summaries of safety and integrated summaries of effectiveness (ISS/ISE)
    • Lay summaries (EU)
    • Health authority meeting materials
    • Trial registration, updates, and results reporting on clinicaltrials.gov and clinicaltrialsregister.eu

resources

Stay ahead of the curve by browsing our extensive library of white papers, case studies, blog posts, and more.

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Drop us a line to learn more about how we can help.