Clinical Monitoring

Clinical Monitoring

We assign skilled, well-trained and experienced Clinical Research Associates (CRAs) to our clinical trials to ensure that the highest standards of quality and professionalism are achieved. We also ensure that clear communications are central to the process and this includes effective interaction with site personnel.

We advocate frequent, proactive site monitoring at the initial stage of patient recruitment into a clinical research studies in order to:

  • motivate site personnel and focus investigators on patient recruitment
  • help identify and resolve early any issues the sites may encounter with the clinical trial protocol, good clinical practice, or overall conduct of the study
  • ensure patient recruitment targets are met in a timely manner
  • ensure that sites’ data quality and accuracy is of the highest standard

Thereafter, a CRA will conduct site monitoring at regular intervals to ensure that:

  • visits are being conducted within the correct time period and in accordance with the protocol
  • the clinical data captured is accurate and of highest quality
  • the study is being conducted in compliance with ICH/GCP guidelines and standards.

In addition to the clinical trial monitoring visits, the CRAs maintain contact with each centre on a regular basis in order to maintain site motivation, optimise recruitment and patient retention and address any issues or queries that may arise.