Emergo works with medical device manufacturers to develop medical device clinical trial protocols and manage clinical trials to ensure successful outcomes. Our worldwide medical device clinical consulting teams are based in the UK, Israel, India, China, Japan and Canada. We have worked with hundreds of medical device companies worldwide on regulatory compliance projects.
Clinical trial monitoring for medical device studies
It is the responsibility of the clinical trial sponsor to ensure the safety of patients and maintain the accuracy and consistency of data collection during the trial. Our clinical trial monitors are medical device specialists and have been fully trained in Good Clinical Practice (GCP). Our medical device clinical trial monitoring services include:
- Overseeing progress of the clinical trial to ensure the study protocol is being followed and complies with GCP and ISO 14155.
- Monitoring enrollment of qualified subjects.
- Ensuring consistency of data collection and patient treatment across multiple sites and communicating/addressing deviations from the clinical trial protocol, SOPs, GCP, etc.
- Reviewing documents to verify that reports, submissions and other documents are accurate and up to date.
- Ensuring that adverse events are reported in accordance with GCP, the protocol, Independent Ethics Committees and any regulatory mandates.
- Preparing clinical monitoring outcome reports after site visits according to established SOPs.
- Compiling final clinical study report and study master files.
Our clinical trial management teams have vast experience with a wide range of medical devices, including many high-risk cardiovascular, orthopedic and combination products. If your company has existing clinical resources, we can work with you to provide some or all of the clinical trial management services listed above. Our ultimate goal is to reduce the time your trial takes and produce a positive outcome for the lowest possible cost.
Please contact us for additional information on our medical device clinical trial management and monitoring services.