Medical Device Clinical Trial Management and Monitoring

Are you preparing to undertake a clinical trial in Europe? Do you need help with investigator or site selection? Do you know what Ethics Committee and Competent Authority approvals your study will require?

Our clinical division based in Germany has expertise setting up, conducting, and reporting clinical trials designed for:

• Demonstrating Proof of Principle or First in Man (FIM) studies.
• Demonstrating the clinical safety and performance or effectiveness of a medical device for CE Marking.
• Obtaining post-market clinical evidence data on devices with CE Marking by means of Clinical Report Forms (CRFs) or questionnaires.
• Obtaining health economic data to support obtaining reimbursement approvals.
• Generating clinical evidence for marketing claims.

Our clinical team will support you in designing your clinical study with appropriate study endpoints, help determine the optimal cohort sample size, study, and follow-up duration, and evaluate the parameters to be collected against the desired evidence to be gained. Furthermore, we support site selection by screening through objective criteria, managing the clinical study sites as necessary, and drafting the study report per the required template and content.

Clinical trial monitoring for medical device studies

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. 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.

Our EU clinical division offers a range of clinical research and CRO services

We have the necessary skillsets to design and run studies, and use the results according to the requirements defined by your company’s plans in the most cost- and time-efficient way possible. To facilitate management, our clinical consulting team has native-level English, Dutch, German, and French speakers, and covers Italian and Spanish jurisdictions. Here’s how we can help:

• Project management of the clinical study
• Study investigator/study site selection/recruitment
• Study design input/review - optimization of endpoints
• Preparation/review of study documentation (i.e. protocol, clinical investigation brochure, case report forms, patient information, informed consent forms, etc.)
• Identification, control and management of qualified independent third parties (e.g., central lab), as needed
• Arrangement of patient insurance
• Competent Authority and Ethics Committee submission and liaison.
• Regulatory Compliance management for the study
• Study monitoring (Study site initiation visits, routine monitoring visits and close-out visits)
• Data management services (incl. data management plan generation, data review, data transfers, etc.)
• Final report
• Trial Master File maintenance
• Quality Control

Our team expertise covers a wide range of devices and study types, including but not limited to FIM studies, prospective CE Marking RCT (blinded or not), and Post-Marketing Clinical Follow Up (PMCF) studies. Under the MDR, the latter will be mandatory in an ever-wider scope of products, with similar initiatives emerging in the US (Real Life Data) and Japan.

Please contact us for additional information on our medical device clinical trial management and monitoring services.