With the recent issue of ICH E6(R2), the Sponsor should develop a systematic, prioritized, risk-based approach to monitoring clinical studies. Also, the new guideline focuses on the possibility for the Sponsor to choose on-site monitoring, a combination of on-site and centralized (off-site) monitoring, or, where justified, centralized monitoring only. The Monitoring plan is now a requirement as per GCP and should describe the monitoring strategy, the monitoring responsibilities of all the parties involved, the various monitoring methods used, and the rationale for their use.
The revisions to the guideline stipulate a more proactive approach to study monitoring, as described below:
- remote source data verification via Electronic Data Capture (EDC) software and risk-based monitoring tools;
- more frequent remote site contact and management;
- less frequent onsite visits, but focusing on building strong and constructive relationships with the site, performing training, promoting GCP and supporting understanding of the protocol;
- working with a central monitoring team that is responsible for data review.
Our CRA is highly experienced in clinical research and familiar with risk-based approach to monitoring.
She has been working for more than 17 years on national and international phase II and III studies, for industry and academic sponsors, experiencing a variety of monitoring techniques.
Her experience as a lead CRA and project manager made her understand the larger context of the monitoring effort.
She has been monitoring clinical studies in various countries of the world (France, Spain, Portugal, Mexico, USA) and her high communication skills enable her to rapidly adapt to any new project.
San.K.Bio Consulting’s monitoring services include:
- Site management, including support with regulatory submissions
- Site qualification visits
- Site initiation visits
- Site interim monitoring visits
- Site close out visits
- Source document review
- Regulatory document review
- Drug accountability
- Report generation