Our writers have significant experience in multiple therapeutic areas, including analgesia, cardiology, neurology, dermatology, gastroenterology, endocrinology, general medicine, immunology, neurology, oncology, pediatrics, psychiatry, ophthalmology, rheumatology, women’s health, and medical devices. Premier Research medical writers have extensive experience with FDA and ICH guidelines and readily adapt documents to meet our sponsors’ preferred styles and formats. Our writers have an average of 4 years with Premier and 14 years in the industry.
Our Services: Medical Writing
Premier Research’s Medical Writing group is a unique collection of scientific experts in Phase 1 through Phase 4 clinical documentation for global regulatory agencies. Our senior medical writers have diverse and complementary academic and professional backgrounds. Their strong analytical and communications skills and project management experience are consistently reflected in high quality and timely deliverables and exceptional client satisfaction.
The Medical Writing group is supplemented with the talent and experience of Thomas Laage, MD, who provides valuable scientific, medical, and strategic input to sponsors and other Premier Research teams. He also provides clinical and regulatory interpretation support on medical writing content. Premier Research’s Medical Writing group is supported by a highly experienced quality control review and document specialist team.
The Premier Research Medical Writing team generates a wide range of critical documents, including protocols, CSRs, investigator’s brochures, manuscripts for publication, INDs, safety updates, integrated summaries of efficacy and safety and other NDA components, Risk Evaluation and Mitigation Strategy (REMs), CTD components, posters, and data presentations.