Medical Writing
At Confidence Pharmaceutical Research, medical writing is more than documentation—it’s a strategic asset. Our experienced writers transform complex science into clear, regulatory-ready content that supports trial clarity, patient understanding, and successful submissions. From first-in-human protocols to global ICFs, we deliver writing that holds up to scrutiny and moves your study forward.
How We Do It?
- Protocol Development That Sets the Standard
- Translate scientific aims into clear, actionable study designs
- Define justified inclusion/exclusion criteria and sample sizes
- Align documents with ICH-GCP and local regulatory requirements
- Integrate feedback from experienced trialists and regulatory experts for precision and flow
- ICFs Designed for Global Use
- Develop informed consent documents that meet regional and ethics committee standards
- Tailor language for conventional, pediatric, and surrogate-consent situations
- Collaborate with local teams to ensure compliance and participant understanding
- Ensure accessibility while respecting cultural and ethical considerations
- Investigator Brochures (IBs) and Clinical Study Reports (CSRs)
- Prepare comprehensive IBs that communicate safety, efficacy, and investigational product data
- Develop CSRs that meet global regulatory requirements and withstand agency review
- Ensure consistency across protocols, IBs, CSRs, and other key study documents to support smooth regulatory review
What Sets Us Apart?
- Extensive experience across therapeutic areas and all trial phases
- Regulatory-grade writing aligned with both global and local authority expectations
- IBs and CSRs developed to withstand regulatory review
- Participant-centered ICFs that meet all regulatory requirements, build trust, and support enrollment
- Integrated collaboration with functional leads to reduce back-and-forth and ensure alignment
- Writing that enhances operational efficiency and regulatory success