Monitoring: overview

For us monitoring means control. Control in the sense that we are able to see, even if we have to look for. When on site or monitoring remotely, following through on issues and maintenance, or creating customized monitoring tools to boost performance, CTX4 stays on top for you.

Our monitors are strategically positioned: we have dedicated monitors in the largest cities with investigational sites yielding the largest enrollment. With comprehensive travel expenses our monitors are ready to be wherever you need them to be.

We protect our customers’ interests – your interests – from Day One: data integrity is ensured, compliance requirements enforced and patient safety entrusted.

Monitoring starts with understanding how to manage sites. It is essential to establish symbiotic relationship with the investigators. Our monitors are trained to act as site liaisons. As long as site’s team members appreciate our being meticulous with documents, they eagerly carry out corrective actions and implement trusted practices. Our monitors convey the idea that we are there to help boost the research process ensuring staying within applicable regulations. Creating partnerships powered by open communication and healthy dynamics, we help sites navigate through the complexities of clinical studies.

Then we try to actively identify any emerging setbacks. Is the study suffering from slow enrollment or delayed submissions of critical data? Do costly delays keep pushing the study further away from database closure and long awaited product approval? There are solutions – and CTX4 has them. Our approach to monitoring extends beyond just working from a checklist – to the success recipe we add our experience. We work diligently to identify non-compliance issues early, proactively problem-solve, implement strategies that prevent reoccurrence, mentor people and conduct comprehensive records reviews.

During data verification of the monitoring visit, a number of important documents are checked and procedures validated: site’s essential documents, subjects’ informed consents, inclusion/exclusion criteria, clinical supplies and storage, safety reporting procedures, site personnel trainings, etc. With the proper attitude, a CRA will not only identify and report problems and issues but also be the first person on sponsor’s behalf to prompt their resolutions.

We pay special attention to:

• managing protocol-related issues on site;
• assisting with handling site data queries;
• utilizing trackers for submitting data in a timely fashion;
• alerting site personnel to approaching deadlines.

In more generic cases, monitors mostly embrace data verification. We encourage our monitors to challenge conventional thinking, to cross-check data and actively search “problem zones”. Sharing best practices within our team and highlighting interesting findings during trainings we increase the chances of identifying vulnerabilities fast and take the opportunity to fix them in time. Thinking logically and strategically is what experience is all about when it comes to monitoring.