Patient safety is the greatest priority when conducting clinical trials. Under the guidance of our Chief Medical Officer, Dr. David Smith, the Medical Safety Services 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:

• Collection & maintenance of global safety data
• Patient registries
• Medical monitoring
• Protocol waiver and compliance assessment
• Serious adverse events (SAEs) surveillance (24-hour coverage)
• Serious adverse event reporting
• Medical device adverse event reporting (MDR)
• Lab safety review
• Medical data review
• Medical coding
• Endpoint adjudication
• Drug Safety Monitoring Board (DSMB) management

Our Medical Safety Services team plays an instrumental role in trials of all sizes and varying complexities. Because we have successfully worked on exceedingly complicated clinical trials, we possess the appropriate staff and business processes to handle the most difficult trials. In fact, our Medical Safety Services 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 gain such confidence in our abilities and why we have provided these services to clients on a stand-alone basis.

Due to the size and composition of our medical team, Integrium possesses additional advantages when conducting all phases of 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 can also be advantageous for our clients when we work with end-point and safety committees, as well as physician advisory boards. Their medical backgrounds enable 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. As a result, they're not only integral team players, but they're also clinical leaders who stand for integrity and medical innovation.