Clinical Trial Management for Medical Devices in Europe
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
Comprehensive medical device clinical study design
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.
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, as well as cover 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 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.