Clinical Trial Documents

Documents that ensure compliance, safety, and operational efficiency.

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Operationally Efficient Documentation

Successful clinical trials depend on clear communication between sponsors, investigators, and patients. We design documents that are user-centric, ensuring that investigators can easily follow protocols and patients can fully understand their participation.

We focus on Plain Language Summaries (PLS) and health literacy principles to improve patient retention and compliance alongside regulatory adherence.

Key Deliverables

  • Informed Consent Forms (ICFs): Creating accessible, easy-to-understand consent forms in multiple languages.
  • Case Report Forms (CRFs): Designing eCRF and paper CRF layouts for efficient data capture.
  • Patient Diaries & Cards: Tools to help subjects track medication and symptoms accurately.
  • Standard Operating Procedures (SOPs): Writing and reviewing SOPs for clinical operations.
  • Study Manuals: Lab manuals, pharmacy manuals, and investigator guides.

Patient-Centric Approach

Our specialized approach to patient-facing documents reduces screen failure rates and improves compliance. By simplifying complex medical terminology into layperson terms without losing scientific accuracy, we empower patients to be active partners in research.

Frequently Asked Questions

Are your ICFs GCP compliant?

Yes, all our Informed Consent Forms are drafted in compliance with ICH-GCP E6(R2) guidelines and local regulatory requirements.

Do you write patient narratives?

Yes, we draft comprehensive patient safety narratives for CSRs, detailing adverse events and medical history with clinical precision.