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Welcome to the last part of our discussion on sites with guest Ted Trafford and Brad Hightower. In Part 2, we talked about the impacts of protocol errors and inconsistencies on sites and recruitment. For this 3rd and final segment, we are diving into a sensitive subject, holdback in payments.
Sponsor Holdbacks in Payments and Their Impact on Sites
Financial holdbacks and delayed payments continue to present significant operational challenges for clinical trial sites. Many contracts between sponsors or CROs and sites include a clause that withholds a percentage of visit-related payments—sometimes up to 20%—until study closeout. This practice places undue financial strain on sites, particularly those operating with limited reserves. Industry data indicate that many sites function with less than three months of operating capital, making withheld funds a potential threat to site viability. The impact extends beyond financial stress; delayed payments can lead to postponed hiring decisions, overburdened staff, and missed subject enrollment opportunities. In some cases, high-performing sites may be unable to scale operations or maintain quality due to cash flow constraints. Payment frequency also remains a critical issue, with delays of 6 months to a year between participant visits and site reimbursement still occurring. Payment system transitions by sponsors or CROs also exacerbate these delays, leaving sites without payment while administrative issues are resolved. These practices reflect a broader trust gap between sponsors and sites, undermining the collaborative foundation required for successful trial execution. Eliminating excessive holdbacks, ensuring timely and predictable payments, and treating sites as valued partners are essential steps toward improving site sustainability and overall study performance.
Aligning Financial Processes with Sites Sustainability
Financial alignment between sponsors and sites is essential for maintaining operational stability and long-term collaboration. Sites must be recognized as businesses with ongoing financial obligations, including staff salaries, infrastructure, and overhead. Practices such as compensating sites for feasibility questionnaires, qualification meetings, and documentation reviewal, even when not selected, reflect a growing awareness of the time and resources required to support study startup. Sponsors that implement monthly payments based on data entered into the electronic data capture (EDC) systems—rather than waiting for full monitoring—demonstrate a practical approach to incentivizing timely data entry and improving cash flow. This model places control in the site’s hands and aligns incentives effectively. However, a growing concern involves the increasing number of items that require separate invoicing, including pass-through costs and conditional procedures. These items often fall outside standard payment triggers, despite being documented in the EDC. The administrative burden of tracking, submitting, and following up on these payments consumes a significant amount of time. Inconsistent processes across sponsors and CROs—ranging from email submissions to portals—further complicate reimbursement and create uncertainty. Lack of transparency in invoice processing timelines and rejection criteria contributes to frustration and financial instability. Sponsors that aim to be considered partners of choice must streamline financial workflows, reduce unnecessary invoicing complexity, and ensure that earned payments are delivered promptly and predictably.
Budget Flexibility
A growing best practice in clinical trial budgeting involves the inclusion of a contingency line item, allowing for rapid response to unforeseen site needs―such as additional advertising or operational adjustments―without requiring formal budget amendments. This pre-approved allocation streamlines processes, enabling quicker sponsor approval and invoicing. Despite its benefits, this approach remains underutilized, as evidenced by recent protocol amendments that introduced new visits without corresponding budget updates—leaving sites unprepared and uncompensated. Such oversights place undue strain on research sites, forcing them to absorb costs or delay implementation.
Another critical issue is the inconsistent reimbursement for screen failures. The effort involved in recruiting and screening participants—regardless of eligibility outcomes—is substantial. Some sponsors recognize this and compensate for all screening activities, fostering stronger site relationships. However, many still limit payments to a certain amount of screen failures, which can demotivate sites, especially when disqualifications stem from uncontrollable factors like lab results or electronic diary compliance. High screen failure rates without compensation can lead sites to deprioritize such studies in favor of those that acknowledge the full scope of their work.
The broader implication is that sponsors who fail to treat sites as collaborative partners risk reputational damage. Sites frequently exchange on their experiences at conferences and meetings, influencing decisions about future collaborations. Sponsors that demonstrate respect, transparency, and fair compensation are more likely to attract and retain high-performing sites. Ultimately, fostering mutual respect and operational flexibility not only improves site satisfaction but also enhances the overall success and efficiency of clinical trials.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
