Medical Device Clinical Trial Management and Monitoring
Emergo will work with you to ensure the accuracy and consistency of data collection during the trial and assure the safety of patients, which are your primary responsibilities as clinical trial sponsor. In addition, our project management team is committed to meeting the non-clinical goals of the study, such as staying within budget, meeting projected timelines, and, if necessary, adapting to protocol changes.
Clinical trial monitoring for medical device studies
Our team members are experienced in clinical studies with medical devices and have been fully trained in ISO 14155 / GCP. Our project management and monitoring services include, but are not limited to:
- Overseeing progress of the clinical trial to ensure the study protocol is being followed and compliance with GCP and ISO 14155 is being implemented.
- Reviewing documents to verify that reports, submissions and other documents are accurate and up to date.
- Monitoring of adherence to the clinical investigation plan and ensuring consistency of data collection and patient treatment across multiple sites.
- Ensuring that adverse events are reported in accordance with GCP, the protocol, independent Ethics Committees and any regulatory mandates.
- Compiling final clinical study report and study master file.
Our clinical team members have experience with a wide range of medical devices products. We will work with you to tailor the clinical trial management services as needed specifically in your company’s situation listed above. Our goal is to meet or stay within the time and financial limits projected for your study.