We help researchers put their ideas into practice. No matter where you are in the process, from conception to close out, we provide a range of services to help run the project efficiently, while maintaining compliance with GCP and the regulatory framework.
Clinitrials understands that investigators don’t often have the time available to manage the details and so provides a range of services to assist including:
- Development of research agreements
- Preparation of Human Research Ethics Committee submissions and amendments
- Protocol development and review
- Participant Information and Consent Form development in accordance with GCP
- Study document development including site files and study manuals
- Provision of templates and tools
- Management of Investigational Product
- Study start up, notification and liaison with regulatory bodies
- Site selection, recruitment and study monitoring
- Site staff relations
- Study close out
For further information, please contact us as we would be happy to discuss your individual needs further.
Frequently for Investigator-Initiated Research, the investigator and/or institution takes on the responsibility as the trial Sponsor. Trial Sponsor responsibilities differ from those of a site Principal Investigator and it is important to understand these different obligations. Consider how you would answer the following questions for example:
- Does GCP outline the essential components of the Patient Information and Consent Form?
- Does the protocol need to contain a monitoring plan?
- Have you heard of Annex 13?
- If you are also the sponsor for your study, are you required to have written procedures or standard operating procedures regarding the management of the trial?
Hopefully you answered "yes" to all of the above, as these are all Sponsor responsibilities under GCP.
It is important to get a trial right, from the beginning, so it runs smoothly and you avoid costly mistakes. We can help get your Investigator-Initiated, GCP-compliant trial underway and help avoid potential unpleasant warning letters from the FDA like these!