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REGULATORY AND MEDICAL WRITING

Medical-scientific oversight of research activities which include clinical and regulatory writing, as well as scientific communications, medical writing consultancy, and education/training material.

Within FTH, Medical Writing is a core part of clinical research and our Clinical Pharmacologists Unit has many years of experience in clinical research, delivering accurate, timely, and cost-effective clinical and regulatory reports to the highest quality and following international scientific standards with the utmost rigor and guarantee. We prepare a Clinical Study Report in the shortest time frame once the database is closed.

Our FTH´s pharmacologists possesses a wide breadth of knowledge and experience drawn from the pharmaceutical industry, clinical research organizations, and academia. Each document produced by FTH must go through four phases: a) scientific, b) statistical, c) editorial, and d) quality control review.

The Medical Writers Unit is responsive and adapts to our customer's needs, using our expertise to transform your diverse and possibly complex data into an evidence-based and accurate account of the clinical profile of your drug in the context of treatment and patient safety.

Medical Writing services include:

  • Interim Reporting of Results

  • ICH GCP Compliant Clinical Study Reports (CSRs) – Phases I to IV, including CSR Synopses for Public Dissemination

  • Statistical Reports and Expert Reports 

  • Study Protocols

  • Investigator Brochure

  • Patient Safety Narratives

  • Clinical and Non-Clinical Sections of the Common Technical Document (CTD), including Summaries and Overviews for the EU standards – also knowledge of the US, Canadian, and Australian Regulatory Authorities and Public Policy

  • Patient Documents and Brochures, including Patient Information Sheet and Informed Consent

  • Pharmacovigilance Documents – i.e. Periodic Safety Update Reports

  • Standard Operating Procedures (SOP) covering all aspects of Drug Development

Scientific Communications services include:

  • Journal / Conference Materials (graphical abstracts, posters and slide sets presentations)

  • Manuscripts and Editorial Support

  • Product Website Content (for both targets: scientific and patient audiences)

  • Educational Material for Patients, Healthcare Professionals and Pharmaceutical Industry Personnel

  • Medical Marketing Reviews and Reports

  • Literature Reviews and Publication planning