Over 50% of all FDA warning letters are attributed to non-compliance by the investigator or clinic staff. Are these professionals careless, incompetent, up to foul play, all the above? Or is the business of conducting clinical trials just that difficult? In the intricate world of clinical trials, the clinical research coordinator (CRC) operates at the heart of the storm. Tasked with the pivotal role of keeping the clinical trial processes in compliance and on schedule, CRCs handle many responsibilities as challenging as they are critical. Yet, despite their central role, CRCs face a suite of ongoing challenges that can test even the most seasoned professionals.
From managing multiple studies with differing protocol demands to coordinating a web of vendor relationships (of which they are often not the primary stakeholder), the job of a CRC is never straightforward. The complexity is further amplified by suboptimal training methods and an alarmingly high turnover rate for CRCs — upwards of 61% (SCRS, 2023) — which all add to the cost and complexity of trial management. Each day, these unsung heroes navigate all these challenges (and then some), striving to maintain the integrity and efficiency of clinical research.
The Balancing Act
CRCs often find themselves in a precarious balancing act, managing multiple studies that each come with their unique, complex protocols. This multitasking is not just about keeping schedules; it's about ensuring each study visit is performed as intended by the protocol, which varies significantly from one trial to another. Challenges arise when a study's protocol requires specific patient management strategies or detailed data collection processes that differ from other ongoing trials. These complexities can lead to errors and inconsistencies, jeopardizing patient safety, data integrity, and ultimately the success of the study intervention itself. Such scenarios demand not only a high level of detail orientation from CRCs but also a dynamic adaptability to switch gears between different study requirements seamlessly.
On any given day, depending on the complexity of the studies they are running, a CRC might see 2-20 patients in a variety of different studies. Throw in an amendment and established processes need to be unlearned and relearned, further complicating the role. In navigating these complexities, ProofPilot offers a robust solution tailored to assist CRCs in managing their diverse and demanding roles. By automating protocol workflows, ProofPilot empowers CRCs with real-time guidance on what actions to take and when; tailored to each study's specific needs. This support helps simplify the management of multiple, varying study protocols, reducing the likelihood of errors and inconsistencies, and delivering an optimal patient experience.
A Web of Interactions
On another front, CRCs face the daunting task of coordinating multiple vendors and technology, each critical to a study's success but also a potential source of complexity. Vendors may include electronic data capture systems, electronic patient-reported outcomes portals, lab portals, and regulatory websites, each requiring careful, timely attention to meet study timelines and standards. It is essential for CRCs to not only understand the specific functionalities and timing requirements of each technology but also to effectively deploy these resources exactly when they are needed in the clinical trial process. Again, ProofPilot simplifies this process by integrating different vendor links into properly sequenced, time-orchestrated tasks, clearly directing the CRCs to the specific technology at the right time. Furthermore, ProofPilot hosts all vendor links in our Site Knowledge Base, providing an on-demand, centralized hub that simplifies access and boosts efficiency in clinical trial operations.
The challenges faced by clinical research coordinators require an intricate balancing act to manage multiple studies with diverse protocol demands and the critical task of coordinating a myriad of vendors. Each study brings its own set of complex requirements, challenging coordinators to maintain precision and compliance across the board. Furthermore, effective technology coordination is essential, as any missteps can lead to extra work and significant setbacks in a study’s timeline and quality. Conducting great science is defined as ensuring researchers conduct the protocol as intended. At ProofPilot, we make sure that happens by simplifying even the most complex study through digital protocol automation.
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