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Medical Writing

Medical Writing

RPM provides medical writing support for various therapeutic indications in all phases of clinical development. We have an expert medical writing team with decades of experience in broad complex medical research areas offering our clients the specific experience and knowledge required for the success of a trial. Our medical writing team has produced scientific and technical documentations for all phase I to IV clinical trials. Our medical writers ensure a comprehensive understanding of the project by being involved in essential project communications to meet strict project timelines.

Our Medical Writing services include:

  • Clinical Development Plans
  • Protocol development for phase I-IV clinical trials
  • Common Technical Document (CTD/eCTD) creation for clinical and non-clinical services including synopsis and overviews for U.S. and European Union Regulatory Authorities
  • Clinical Study Reports compliant to ICH GCP
  • Regulatory Briefing Documents
  • IMP dossiers development
  • INDs (Investigational New Drugs)
  • Investigator Brochure development
  • SOP development
  • Regulatory dossiers
  • CSR Synopses for public disclosure
  • Therapeutic area consulting
  • Informed Consent Form
  • Case Report Form (CRF) Design
  • Trial particular questionnaire design
  • Scientific and medical literature review
  • Literature Search
  • Statistical Analysis Plan (SAP)
  • Review of coding and safety data listings and tables
  • PSURs (Periodic Safety Update reports
  • DSURs (Development Safety Update reports)
  • NDAs (New Drug Applications)
  • Integrated summaries for efficacy or safety (ISE/ISS)
  • PIP (Paediatric Investigational Plan)
  • Patient Safety Narratives
  • Patient information leaflets
  • IND Annual Reports
  • Nonclinical Study Summaries
  • Written and tabular summaries
  • Data Safety Monitoring Board (DSMB) manuals
  • Integrated clinical and statistical reports meeting global regulatory requirements
  • Expert reports and executive summaries
  • Interim/final study reports preparation
  • Medical monitoring plans
  • Regulatory Submissions in eCTD format
  • Medical interactions with Competent Authorities
  • Abstracts, Posters and Journal Articles
  • Manuscript preparation
  • Publication planning
  • Medical and patient education materials
  • Product website content writing for both industry and patient audiences
  • Advisory panel presentations
  • Support to R&D and marketing departments
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