Clinical Trial Documentation

Our Clinical Trial Documentation services help sponsors generate documents which meet (local) requirements and applicable guidelines. A wide variety of documents can be reviewed or created on sponsor’s request.

Proper documentation is critical to the success of a clinical study. Every aspect of the study must be documented in order to obtain useful data and demonstrate compliance with Good Clinical Practice (GCP) guidelines and with all applicable regulations.

Our services help sponsors generate documents which meet (local) requirements and applicable guidelines. A wide variety of documents can be reviewed or created on sponsor’s request including for example:

  • Clinical Investigation Plan / Protocols
  • Investigator Brochure (IB)
  • Patient’s Informed Consent (IC) form
  • Investigator Regulatory File​​​​​​

​​​​​​​Feel free to contact us so we can further help you with your Clinical Trial Documentation.

How can we help you?

Want to hear more about our services or how we can support your project? Feel free to contact us with any questions you may have.

Contact us