Protocol Development

The protocol is a document that details how a clinical trial or study will be conducted. Proper protocol development is the foundation for a successful research study. The document contains pertinent information on the study’s background, rationale, methodology, and a plan to ensure the safety of subjects. HM Healthcare Partners specializes in quality protocol development to your exact specifications. Our strategic design and planning methods always take into consideration important key elements such as sample size, deviations, blinding and randomization procedures while maintaining both the International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) recommendations for protocol content.

Our writing services include:

  • regulatory affairs/submission
  • Institutional/Independent Review Board (IRB)
  • data safety monitoring planning
  • protocol development
  • grants management and reporting
  • informed consent forms
  • medical education materials
  • research administration documents
  • peer-review
  • study forms/compliance logs
  • study-wide/baseline forms
  • literature reviews and meta-analysis
  • poster presentations
  • monographs
  • biosketch
  • white papers
  • PowerPoint presentations
  • manuscript development
  • medical writing services in clinical operations and data management
  • grant writing and development (R01, R03, R21, R21/33, SBIR/STTR, NSF, CDC, VA, private, non-profit, industry, CME)

Contact us for more information.