Setting up the project team
When setting up a clinical investigation it is critical to assign the responsibilities for managing the clinical investigation to a team with the appropriate experience, training and education. Clinical investigations are complex, and the data generated are expected to be ethically and scientifically valid, reliable, and robust. If the clinical investigation is not appropriately conducted, mistakes could risk a project’s success, and consequently market entry or continued presence on the market could be jeopardized.
The clinical study team should know the regulatory requirements applicable to clinical study conduct and the unique aspects of medical device clinical studies. In contrast to pharmaceutical studies, the success of a medical device clinical study is strongly dependent on the clarity of the clinical investigation plan (CIP) in describing how the medical device should be studied. In addition, it is important to emphasize any training requirements, details related to the instructions for use, and the expertise required by the health care professional using the specific medical device technology.
The clinical study team should have relevant experience and appropriate training in the conduct of medical device clinical studies (e.g., working knowledge about ISO 14155) before assuming the responsibility to manage or lead the development of these critical activities.
The specific roles in the clinical team will depend upon the Sponsor’s organization, the type of medical device under investigation, and the kind of clinical investigation being set up (pre-market, post market, interventional or observational).
Study team
The study team should include different competences. In particular, some of the specific roles include:
- Project manager
- Clinical research scientist and associates
- Product specialist
- Regulatory affairs specialist
- Biostatistician
- Data manager
- Study monitor
- Data Safety Monitoring Board (DSMB)
- Centralized laboratories (e.g. core lab)
When Sponsors of medical device clinical studies lack adequate internal resources, it is advised to outsource various responsibilities to ensure that the study managed is conducted by professionals with adequate experience.
Manufacturers/Sponsors may choose to appoint a medical device Clinical Research Organization (CRO) to support with the set up and management of their medical device clinical investigation.
AKRN can provide project managers and consultants with the appropriate experience, training, and education to successfully conduct clinical investigations in Europe.
