Medical Writing

Medical Writing

Azelix’s Medical Writing Team ensures project timeline adherence by being highly responsive and committed.

The success of a clinical development program depends on the proper documentation of research plans and results. Azelix offers a range of flexible solutions to support various clinical study documentation needs.

The medical writing team averages 25 years of experience, and many are Ph.D.  Combined experience exceeds 150 years as a team.

Our team of medical writers have experience working with a broad range of indications and therapeutic areas. We focus on offering flexible solutions to meet your needs in different stages of product development.  We can assist you in the development, preparation, and review o and publishing documents in support of regulatory submissions and clinical trials, including:

  • Study protocols
  • Informed Consent Documents
  • Clinical Study Reports (CSRs)
  • Case Report Forms (CRFs)
  • CRF Manuals
  • Study Reference Manuals
  • Patient Diaries
  • Clinical Trial Registry Documents
  • Safety Narratives
  • Clinical Evaluation Reports (CERs)
  • Investigator’s Brochures (IBs)
  • Investigational New Drug (IND) Applications
  • IND Annual Reports
  • New Drug Applications (NDAs)
  • Drug Master Files (DMFs)
  • eCTDs: Module 2 (2.2, 2.4, 2.5, 2.6, 2.7) and Module 5 (ISS, ISE)
  • 505(b)(2) Searches and Summaries
  • Marketing Applications
  • Orphan Drug Applications
  • Drug Establishment Registration
  • Standard Operating Procedures (SOPs)
  • Meeting Reports
  • Manuscripts for Publication

All documents undergo an internal review to ensure consistency and quality.

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