It’s not easy to navigate through all clinical regulatory needs, but genae is happy to assist you through the different processes. Thanks to years of experience and close cooperation with key opinion leaders we will guide you to fast market approval.
genae can help you design your clinical study to meet regulatory requirements keeping in mind your specific needs including optimal data measurements to support your product claims.
Our Clinical Trial Documentation services help sponsors generate documents which meet (local) requirements and applicable guidelines. A wide variety of documents can be reviewed or created on sponsor’s request including for example the Clinical Investigation Plan, the Investigator Brochure or the Informed Consent Form.
genae supports sponsors and investigators by identifying and collecting approval from all involved bodies, such as Ethical Committees (EC), Institutional Review Boards (IRB), National Competent Authorities and FDA. Expert knowledge of local legislation and a good relationship with the different agencies is crucial for a successful trial submission.
I’ve seen genae evolve from being a start-up CRO just more than 10 years ago to the global, important player it currently is in the medical device field.
— Dr. Mathias Vrolix
Head department Cardiology & Interventional Cardiology
East Limburg Hospital, Belgium
Because genae has worldwide coverage, we can act as your independent legal representative. This is especially helpful if you have no local presence in certain geographical areas.
Every clinical trial should have an efficient safety program and appropriate level of protection for the study subjects. genae has a transparent and reliable approach to safety data and a sturdy quality system. We can offer you a comprehensive Safety Management Plan, tailored to your device and the development stage.
Data Safety Monitoring Boards (DSMB) and Clinical Event Committees (CEC) are crucial to provide independent oversight of study data and methodology, and to review adverse events and protocol deviations. genae has a close collaboration with key opinion leaders across the world and hence can recruit expert physicians to form highly qualified DSMB and CEC. We manage their activities and ensure endpoints are adjudicated. The latter can be done remotely via a proprietary online platform or during physical CEC meetings.
We provide full adverse event management and reporting services:
Our multilingual team will make sure any adverse events are documented and managed properly.
Navigating and executing mandatory reporting requirements is standard work for genae. To submit your case to the appropriate regulatory body, genae will obtain all required information in preparation of the report. Whether it is the FDA or European Competent Authorities, we understand the regulatory requirements and their compliance obligations.