Medical Writing

The difference between good writing and good medical writing cannot be overstated. We understand the difference! Medical writing is an integral part of regulatory compliance and clinical research. Our medical writers work closely with project management, pharmacovigilance, statistical, regulatory and clinical data management teams to deliver accurate documentation and strong story telling. Documentation that meets the utmost ethical and scientific standards is the end goal for all of our medical writers. Our skilled medical writers bring a deep understanding of publication strategy to support manuscript writing making them more than just good writers.

Pearl Pathways’ medical writing services include clinical and regulatory writing, as well as scientific communications, education materials, and medical writing consultancy.

Examples include:

  • Protocols, Informed Consent Documents, and Patient Brochures
  • Literature Reviews
  • Investigators’ Brochures
  • IND, IDE, BLA, NDA, ANDA, Clinical and non-Clinical Sections of the Common Technical Document (CTD)
  • Pre Market Tobacco Applications (PMTA)
  • Clinical Evidence Report (CER)
  • Conference Materials (abstracts, poster presentations and slide sets)
  • ADME, Pharmacokinetic, Pharmacodynamic, Toxicology Analysis
  • Preclinical and Clinical Reports and Summaries
  • Clinical Safety and Efficacy Reports
  • Manuscripts
  • Publication Strategy and Planning
  • Editorial support/Journal/Conference Submission
  • Standard Operating Procedures (SOPs) Covering all Aspects of Drug Development
  • Product Website Content (both scientific and patient audiences)
  • Posters and slide decks

Pearl Pathways’ medical writers become part of your team and are mindful of your project needs. We use our extensive scope of knowledge working with the life sciences industry, academia, and clinical research organizations to guide you through your project. All documents produced by Pearl Pathways undergo thorough statistical, editorial, scientific, and quality control review. If the document you are looking for isn’t listed above, give us a call.