Services

Delve can prepare documents for all phases of clinical development: Phase 1 to Post Marketing Observational Studies.

Delve can work with clients templates and style guides or support clients who do not have their own document templates by utilising ICH GCP compliant templates that have been prepared by Delve.

Delve works closely with clients, selected investigators, study sites and other sub-contracted services as required to produce high quality documents including:

  • clinical study protocols;

  • protocol amendments;

  • clinical study reports;

  • investigator brochures;

  • patient information sheets and consent forms;

  • abstracts;
  • patient safety narratives.

Preparation of all documents by Delve also includes an independent quality review of documents by a member of the Delve team (who has not been involved in writing the document) for compliance with ICH GCP, review for consistency of text, administrative, typographical and formatting completeness.