Drug Safety and Medical Monitoring
In the hands of experts!
Patient safety is the greatest priority when conducting clinical trials. Under the expert guidance of our Chief Medical Officer, Dr. David Smith, the Medical Affairs team at Integrium operates with the highest levels of accuracy, responsiveness and ethics — earning the respect of investigators and clients alike. Our extensively trained medical staff (MDs, RNs, and PAs) work closely with clients, internal teams and investigator sites to ensure strict adherence to all protocols, as well as GCP/ICH guidelines.
Our core services include:
- Medical monitoring
- Protocol waiver and compliance assessment
- Serious adverse events (SAEs) surveillance (24-hour coverage)
- Lab safety review
- Medical data review
- Endpoint adjudication
Our Medical Affairs team plays an instrumental role in trials of all sizes and varying complexities. Because we have successfully worked on complicated clinical trials, we have the staff, expertise and equipment to handle the most difficult trials. In fact, our Medical Affairs team has monitored international outcomes trials with more than 6,000 subjects located at investigator sites around the world. Our trial-tested expertise is why many clients have such confidence in our abilities and why we have provided these services to clients on a stand-alone basis.
Because of our large medical team with its varied expertise, Integrium has additional advantages when conducting medical monitoring. We can leverage peer-to-peer relationships between our project medical officers and site investigators. The in-depth clinical training of our medical officers also helps clients when we work with end-point and safety committees, as well as physician advisory boards. A medical background enables them to understand the practical application of the research and better interpret the “gray areas” that so often occur when converting medical information into data. These are not merely integral team players, but also clinical leaders who stand for integrity and medical innovation.