The expression “the best laid plans” is particularly applicable to clinical study execution. Even the most carefully conceived studies have the potential to go awry because of problems with patient enrollment, slow study startup, protocol execution, patient retention and data quality. While there are a variety of solutions for these issues, improved site management is one easily attainable cure.
Site management is key to successful clinical research, and Frenova’s extensive site network and expert site recruitment and support services are ideally suited to deliver the reliable performance and high-quality data you need to advance new medicines and therapies. Our site management solutions streamline research in four main ways: optimization of enrollment, streamlined communications and focus, patient retention enhancement and data quality improvement.
Optimize Enrollment and Accelerate Study Startup
80% of clinical studies experience interruptions because of problems with patient enrollment, leading to $600K-$8M in lost revenue for every day delayed.1,2 Frenova’s leadership in site management helps you meet enrollment goals and reach milestones on time.
We enhance enrollment by first optimizing potential study protocols for patient and site centricity. With our years of research experience, we help sponsors identify and remove operational weaknesses so protocols are executed in less time resulting in attractive studies patients will want to enroll in. We also educate patients on the importance of clinical research and the various aspects of participation. This two-pronged approach streamlines patient enrollment for an accelerated study startup, as shown by the success of investigators within our exclusive alliance of expert clinical trial sites, who have enrolled twice as many patients compared to other sites.3
Frenova also offers site management services that further accelerate research, including protocol feasibility assessments and site identification and activation. These solutions result in significantly faster startup. For example, sites in our alliance activate about 63 days after selection and enroll patients 52 days later, adding up to startup time of just 115 days. In comparison, the industry average is 210.3
Streamline Communications and Focus for a Superior Study Execution
Sites are busy caring for their patients, managing their practice and running studies. When you add the additional burden of study project management, it’s much easier for sites to make costly mistakes that could lead to a protocol change, a complication which one study found can cost sponsors up to $500,000 in additional expenses and extend study timelines by nearly three months.4
Frenova offers clinical trial project management services to streamline site focus and communications for a superior study execution. By partnering with our experts, investigators are freed from worrying about budgets, timelines and other managerial work so they can focus on patient care, good science and data analysis. Investigators are also included in regular support meetings, fostering clear and open communication that helps efficiently and strategically navigate potential challenges.
Enhance Patient Retention
Patients are more likely to enroll in a trial if they interact with a focused, enthusiastic investigator.5 However, managerial tasks associated with project management pull investigator focus away from their patients and research, often leading to patients dropping out of studies. By removing the burden of such managerial tasks, Frenova’s site-supporting services allow investigators to give patients the attention and care they deserve. If patients feel heard, valued and cared for, they are more likely to remain enrolled and engaged in a study.
More Reliable Study Performance for High-Quality Data
Simply put, an unreliable, underperforming study will result in low-quality data. If investigators are overwhelmed with project management or administrative work, they are more likely to make protocol or data reporting errors. Additionally, if patients feel unsupported, they are less likely to adhere to the protocol and more likely to improperly self-report. Frenova’s site management services help keep both investigators and patients on track, which in turn helps studies produce high-quality data ideally suited to the intended use population.
Improved Site Management Is the First Step to Research Optimization
Frenova optimizes study startup and enrollment, streamlines communications, enhances patient retention and improves data quality to keep your study on schedule and on budget. Our harmonized, managed umbrella site structure ensures quality across all locations so you can focus on advancing the development of new medicines and therapies.
Learn more about how our partnerships lead to improved site management and optimized research for better results, faster.
1Desai, M. Recruitment and retention of participants in clinical studies: Critical issues and challenges. Perspect Clin Res. 2020;11(2):51-53.
2Hargreaves, B. Clinical trials and their patients: The rising costs and how to stem the loss. Pharmafile. http://www.pharmafile.com/news/511225/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss.
3Kurt, Mussina and Christina Kahn. F1RST Up®: Accelerating Clinical Trial Start-Up. Frenova Renal Research.
4Getz, K. Improving Protocol Design Feasibility. doi:10.3390/ijerph110505069
5Fogel, DB. 2018. Factors associated with clinical trials that fail and opportunities for improving the likelihood of success: a review. Contemporary clinical trials communications, 11, pp. 156-164.