Key Takeaways | Pharma Services Success: Clinical Trial Site Partnership Case Study

During this webinar, our speakers provided insights into the complex relationships between clinical trial site management organizations and physicians and other providers, plus tips for successful partnerships and legal structures to be mindful of.

Top takeaways included:

1. Structuring partnerships between clinical trial sites and provider organizations requires careful consideration of legal and regulatory compliance, especially in payment arrangements and data sharing. There is significant sensitivity surrounding the patient data required for identifying and recruiting clinical trial subjects, so it is important to consider how patient data will be shared. In addition, it is important to consider what services or functions provider organizations will perform in any subject pre-screening or recruitment arrangement that will involve payments to the providers. To mitigate fraud and abuse issues, it is critical to ensure that payments being made to the providers for their services are of fair market value.
2. Joint ventures can provide a more permanent and branded structure for clinical trial partnerships, but they come with increased complexity and compliance requirements. One of the key benefits of forming a joint venture (JV) entity is that it is more permanent, which can also help create a brand that can be used with patients and sponsors, enhancing the partnership’s visibility and credibility. However, forming a JV entity also introduces inflexibility and additional regulatory challenges.
3. Effective patient recruitment and compliance with Good Clinical Practices (GCP) are critical for the success and integrity of clinical trials. A key aspect of clinical trials is ensuring the study has a critical mass of patients who are qualified for the study. During patient recruitment, it is important to avoid coercive practices, such as promising a cure or comparing the investigational product to approved products or treatments. Proper record keeping is also crucial in clinical trials, and failure to maintain proper records can result in the exclusion of sites and the invalidation of data. For these reasons, in any transaction involving a clinical trial site management organization, it is important to conduct thorough regulatory due diligence to assess risk associated with the target’s regulatory infrastructure.