Clinical Regulatory and Safety Services

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.

​​​​​​​Clinical Strategy

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.

Clinical Trial Documentation

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.

Clinical Trial Submissions

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.


Mathias Vrolix

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


Legal Representation

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.

Safety Management

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.

DSMB & CEC services

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.

Adverse Event Management

We provide full adverse event management and reporting services:

  • initial documentation of adverse event report
  • event triage
  • creation of logical and comprehensive narrative

Our multilingual team will make sure any adverse events are documented and managed properly.

Regulatory Compliance

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. 

staicy

staicy, our digital health data management platform, allows you to connect the dots of your health & research project by managing, analyzing, correlating and integrating your data.

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