3 Practical Solutions For Easing Site Burdens
By Rosalie Filling, VP, senior global head, R&D operations, Endo
For many patients, the frustration of navigating an overstretched and under-resourced medical facility, whether for clinical care or research, is all too familiar — long waits to secure an appointment, burnt-out staff who are stretched too thin, and a general loss of support. What is the root cause of these issues?
Clinical trial sites are pivotal in pushing the boundaries of research, serving as the biopharma industry's biggest ally in bringing medical breakthroughs to patients in need. Despite their crucial role, sites have grappled with significant challenges recently, including disproportionate compensation and delayed payments, insufficient staffing, and cumbersome technology. According to the Society of Clinical Research Sites, today, sites are operating at a mere 60% of their resource capacity.
Having worked with multiple biotech and pharmaceutical companies over the past 25 years, and as a breast cancer survivor who has participated in clinical trials, I have come to understand that sites are not just our partners — they are our lifeline. To ensure this important work continues, clinical trial sponsors must explore strategies that enhance their support of sites, allowing them to focus on what matters most: providing quality patient care.
Pay Sites For The Work That They Do, And Pay Them On Time
Clinical trial sites often operate on a financial tightrope, living from one paycheck to the next. One study noted nearly a quarter of studies failed due to lack of funding. Further, through our conversations with industry organizations and clinical trial sites, we have seen that payment processes are notoriously slow, with 90-day payment terms frequently not met on time.
For sponsor company financial teams, the practice of delaying payments to conserve cash is a shortsighted strategy that risks alienating vital partners and participants alike. However, the landscape is beginning to shift. Trial sites are increasingly asserting their needs by selectively choosing which clinical trials to participate in, reflecting their growing discontent with current practices.
The solution is straightforward — ensure adequate and timely payments. By doing so, sponsors can foster trust with sites, a crucial step to sustain the future of clinical trials. At Endo, we do this is by paying sites directly and working with corporate partners to get exceptions for typical pharma payment timelines.
Build Stronger Relationships With Sites To Ease Their Burdens
For many sites, the challenges they face are not merely about funding but operating, with teams often stretched far too thin, requiring site employees who should be prioritizing patient care to be bogged down with managing cumbersome administrative and operational tasks. In this context, the relationships fostered between sites and sponsors become even more critical.
At Endo, we have established new roles, such as site relationship managers, as a way to solve this challenge. These professionals, who typically have firsthand experience working at clinical trial sites, review materials to understand their impact on site operations and work proactively to mitigate these burdens, thereby easing the operational load on site staff, allowing them to focus more on patient care.
With roles like this in place, sponsors can better position themselves to genuinely address sites’ most pressing needs. This can include providing funding to facilitate patient logistics, such as covering or reimbursing appropriate and reasonable travel costs for patients who may not have access to transportation. By opting for practical solutions such as site relationship managers, we can alleviate some of the site’s stress often associated with research participation.
Include Sites In Protocol Development
Our industry tends to overcomplicate processes, to the detriment of both sites and patients. When sites are not involved in the selection or testing of new technologies or the development of clinical trial protocols and processes, sponsors may inadvertently choose systems that integrate poorly with existing workflows. What was once thought of as a simple task can become a complex, time-consuming process that disrupts site operations.
With this, it is essential to optimize clinical trial protocols, systems, and tools with consideration of sites’ needs as a priority. One way to address this is to involve sites in the development process. At Endo, we created a site advisory board consisting of site managers, site directors, nurses, and other essential personnel that provides us with feedback on operational aspects to help us improve how we conduct our trials.
Imagine the impact if everyone adopted this approach. If we collectively demanded that technology providers involve sites in their testing and protocol development, they would be compelled to adapt. In turn, we’d ensure our advancements genuinely serve those who need them and generate better outcomes.
While implementing these changes takes time, the benefits of building stronger relationships across our industry and creating more user-friendly, efficient systems are immeasurable. By partnering with clinical trial sites to identify ways to provide the support they need, sponsors make an even greater difference in the lives of patients and in the pursuit of medical innovation.
About The Author:
Rosalie “Rosie” Filling has transformed R&D operations in every company she has worked for, developing clear-cut strategies to advance clinical trials with high-quality operational execution and scientific excellence. Rosie’s focus is always on the end users — the patients. Bringing new and, at times, life-saving medications to people in need drives Rosie’s sense of purpose. Rosie is a powerful thought leader at Endo and across the industry, and she is especially proud to mentor the industry’s future leaders and difference makers. Through her work across the industry, she has earned a reputation as a tireless advocate for clinical sites and the patients they serve, believing that they are key to the future of medicine and health. As a breast cancer clinical trial participant, she knows firsthand that her work can positively impact and improve lives.