Many investigator-led studies fall under the remit of the EU Clinical Trials Directive 2001/20/EC, requiring Good Clinical Practice (GCP) in clinical trials of investigational medicinal products. The Directive requires a clinical trial Sponsor for all studies, responsible for matters such as:
- Securing Competent Authority and Ethical approvals
- Ensuring the trial is conducted in compliance with GCP
- Ensuring the trial adheres to pharmacovigilance requirements
- Putting suitable insurance in place to cover sponsor liability.
It is important to ensure that your trial is compliant with the EU CT Directive. For example, investigator-initiated trials of approved drugs used within their licence, including non-commercial trials (with no pharmaceutical company involvement) must meet the Directive’s requirements.
We can undertake much of the administrative burden that comes with clinical studies. The Directive allows the delegation of Sponsor functions to a company such as Java Clinical Research, although ultimate responsibility will remain with the Sponsor. Java’s experienced team has in-depth knowledge and understanding of Sponsor responsibilities under the EU CT Directive. As well as our primary services supporting clinical trials, we provide assistance in areas such as:
- Developing your study protocol to ICH GCP Standards
- Ensuring that all Competent Authority, EC and local approvals are obtained
- Setting up a Trial Master File
- Establishing required Standard Operating Procedures
If you need support in this area, we look forward to talking with you.