Outsourcing for Medical Device Studies
Strengthening the clinical trial enterprise is a high priority for the U.S. Food and Drug Administration (FDA) Center for Medical Devices and Radiological Health (CDRH). The emphasis on well-controlled clinical trial programs and increased regulatory pressure for more meaningful, clinical data means that medical device companies must develop strategies to expand their capabilities for carrying out clinical trials.
Evaluation and development of strategies include deciding whether to support the clinical program internally, to fully outsource to a clinical research organization (CRO) or to use a combination of internal and external resources. Key considerations should be taken into account before deciding a study support model. In any case, the support model chosen should facilitate the medical device company meeting all its legal, regulatory and ethical obligations as a sponsor of the clinical trial.
Key Considerations in Deciding a Study Support Model
An assessment of the company’s internal capabilities and limitations when deciding how to support the study should be completed. Some of the important factors to consider include:
- What kind of study is needed?
- Who has the expertise in the therapeutic and/or technology area?
- Is data to be prospectively or
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