Clinical Trial Documentation.
Technical & administration services to support sponsors.

What does Clinical Trial Documentation cover?

Clinical trial documentation encompasses a collection of essential records necessary for the planning, authorization, execution, and evaluation of a clinical trial. Throughout the various phases of developing a medicinal product, these documents play a pivotal role in presenting the narrative based on the trial data towards success and ultimately Marketing Authorization.

Achieving this demands a wealth of trial experience, expertise, and meticulous planning.

A central document in this context is the Trial Master File (TMF), along with its digital counterpart, the eTMF. The TMF houses the “essential documents” crucial for sponsors, Contract Research Organizations (CROs), investigators/institutions in managing the trial.

The TMF is also used by monitors, auditors, and inspectors to scrutinize and validate that the trial was conducted within regulatory requirements and followed the principles of Good Clinical Practice (GCP). A non-exhaustive list of these essential documents can be found in section 8 of the ICH GCP guideline.

Within the TMF it is necessary to separate documents that are exclusively sponsor generated and/or held from those documents of the investigator/institution. A sponsor or CRO’s quality management system and Standard Operating Procedures (SOPs) must oversee all aspects of the TMF and ensure it is possible to reconstruct the decisions, justifications and activities conducted during the trial. Click for the complete European Medicines Agency guideline on TMFs.

How Aeigisana’s Clinical Trial Documentation Services support sponsors?

Safety focused.

Our expert Clinical Safety team understands all aspects of essential and additional clinical trial documentation within the context of clinical safety to support sponsors’ documentation and administration requirements, including review and advice on the best approach to set-up all document safety sections including your Protocol, Reference Safety Information, Study Reports and beyond.

Common essential documents we provide services for:

  • Investigator’s Brochure (IB)
  • Clinical Study Protocol
  • Subject Information and Informed Consent Form
  • Clinical Study Reports
  • Case Record Form (CRF)