Study start–up and pipeline management are fraught with challenges that can hinder progress and efficiency. These complex processes involve meticulous planning, coordination, and execution from all parts of a research site organization, leaving ample opportunity for delays. Despite advances in technology and methodologies, research teams continue to face significant challenges that can extend timelines and increase costs. In this blog, we’ll explore the top five challenges in clinical trial study start–up and pipeline management and discuss how the RealTime-Devana, previously PROPEL, platform can help overcome these obstacles, ensuring streamlined and successful trial execution.
Challenge 1: Site Selection and Activation
Identifying and activating the right clinical trial sites is crucial, yet this process often presents a significant bottleneck for larger networks. The selection process involves evaluating sites for their patient population, infrastructure, previous performance, and capacity to conduct the trial efficiently. To stay competitive, networks want to distribute the right opportunities to the right sites, while sites want to be the first to respond to new opportunities with accurate, timely data. Anything that slows this process can be a problem in securing new trials from CROs and sponsors.
Solution: Devana’s data-driven site selection tools help networks quickly identify optimal sites based on data already in the system, including historical performance, past recruitment efforts, investigator capabilities, and physical equipment. The platform also facilitates seamless communication and support during the activation phase, ensuring sites are ready to start trials promptly and have all the information they need. If responses from either side, or even external contacts such as CROs and sponsors, ever slow down or stop – Devana provides automated alerts to keep everyone on track.
Challenge 2: Patient Recruitment and Retention
Recruiting and retaining the appropriate number of participants within the required timelines is consistently a top challenge for research sites. Many trials fail to meet their enrollment targets, leading to delays and increased costs.
Solution: Developing a comprehensive patient recruitment strategy that includes targeted outreach, education campaigns, and leveraging digital platforms can improve recruitment rates. Ensuring a positive patient experience and providing support throughout the trial can improve retention. Devana can help track methodologies from past trials, informing future decisions. And by integrating Devana with your CTMS, central teams can track real-time recruitment statuses throughout the entire life of a trial – all in one place.
Challenge 3: Budget Management and Financial Planning
Budget overruns and financial mismanagement are common issues in clinical trials. Inaccurate budgeting can lead to insufficient funding, impacting trial progress and outcomes. Tracking potential new incoming trials is also key, as knowing how much you have coming down your pipeline can help inform better decision making.
Solution: Devana offers robust budgeting tools that provide real-time insights into financial status and even allows for projections of potential trials. By integrating project management features with budgeting capabilities and business development tools, Devana enables organizations to manage expenses more effectively, anticipate future financial needs, and maintain flexibility to adjust for unexpected costs.
Challenge 4: Study Start-up Milestones
Consistently advancing trials through study start-up can be difficult with many potential pitfalls and opportunities for delay. Additionally, navigating the regulatory landscape can be one of the most daunting aspects of any clinical trial, with numerous sets of regulation depending on indication and trial type. Staying compliant with these varying requirements while also managing to progress trials at a steady rate is critical to growing your organization.
Solution: Devana centralizes and standardizes study start-up, tracking progress across all sites and measuring milestone completion metrics. Automated tasks and alerts are generated when tasks such as feasibility or PSV/SIV scheduling hit a snag, making sure delays are measured, visible, and readily addressed. Devana also provides powerful document management and automates many aspects of study start-up, including compliance workflows, providing real-time visibility into approval statuses. By streamlining the entire study start-up process, Devana helps ensure timely submissions and reduces the risk of tasks or entire trials falling behind.
Challenge 5: Data Collection and Management
Having real-time insight into how trials are progressing at various sites is key to growing your research organization. Ensuring the integrity and quality of data collected during a clinical trial is also vital, particularly to prove past successes to new CROs and sponsors. Inconsistent or lacking data collection methods can impact decision making and, ultimately, an organization’s bottom line.
Solution: Devana makes it easy to track and monitor trial opportunities from CROs and sponsors, resulting in robust pipeline management where you can gain insights into potential trends and help forecast for future trials. As trials move through the system, Devana automatically captures metrics such as site responses, turnaround timing, milestone progress, and more. Powerful dashboards and reports make it easy to share insights and historic data both internally and externally with CROs and sponsors, helping win more opportunities based on your organization’s past accomplishments.
Conclusion
The challenges faced by clinical research organizations in study start–up and pipeline management are significant, but they are not insurmountable. By understanding these challenges and implementing strategic solutions with Devana’s comprehensive platform, research teams can enhance efficiency, reduce timelines, and ensure the successful execution of clinical trials. Embracing technological advancements, fostering strong collaborations, and maintaining a proactive approach to problem-solving are key to overcoming these hurdles and advancing clinical research.
