Our unique operating system does raise questions by sponsors and CRO’s as they have previous experience of the more “mainstream” options normally associated with patient at Investigator sites. Nevertheless, provision of detailed explanations of how our various processes and procedures meet GCP compliance requirements soon alleviate concerns and any preconceived misconceptions.
How do we exercise PI oversight?
- Effective Green Light control procedures
- Ongoing, regular communication with our Sub-Investigators
- Frequent management meetings
How do we control IMP?
- Temperature monitored, documented procedures are in place from receipt until disposal of all IMP.
How do we deal with ethics?
- CPS Research is a single site.
- We have in depth experience of REC submissions.
- We have dedicated staff responsible for obtaining the necessary approvals.
How does study monitoring work?
- Sponsors have the advantage of recruitment numbers from between 1 and 30 GP practice locations but CPS Research procedures allow cost efficient centralised monitoring at the main office
- Monitors can still visit GP practice locations as required