Medical Writing

Medical Writing Services

Whether done as part of a clinical trial or as a stand-alone project, the professional medical writers at PRORELIX RESEARCH combine medicine, science, and technical writing to deliver concise documents for all stages of regulatory, project management, and final reports.

Clinical Research Writing
  • Study Synopsis & Protocol

  • Clinical Study Report (CSR)

  • Investigator’s Brochure (IB)

  • Informed Consent Form (ICF)

  • Case Report Form (CRF)

  • Quick Design And Layout

  • Direction High Level Idea

  • And Concept Illustration

Regulatory & Pharmacovigilance
  • Clinical sections of common technical documents (CTDs) & new drug applications (NDAs)

  • Risk Management Plans (RMP)

  • Periodic safety update report (PSUR)

  • Benefit risk evaluation report

  • Patient safety summaries/ narratives

  • Summary product characteristics (SPC)

  • Package Inserts

Publication
  • Abstracts writing

  • Manuscript writing

  • Journal articles & submission

PRORELIX RESEARCH has undertaken a wide range of medical writing assignments such as:
  • Protocols

  • Clinical Study Reports

  • Literature Research

  • Technical Document

  • Case Narratives

  • Abstracts and Manuscripts

  • Documentation for congress exhibits (abstracts, posters, and slide presentations)

  • Investigator’s Brochures (IBs)

  • Investigational Medicinal Product Dossiers (IMPDs)

  • Investigational New Drug documents (INDs)

  • Pediatric Investigation Plans (PIPs)

  • Risk Management Plans (RMPs)

  • Common Technical Document (CTD/eCTD)

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