Site Enablement: How Sponsors and CROs Can Enhance Their Clinical Trials in a Competitive Landscape

The evolution of clinical research has been dependent on the conversion of Healthcare Organizations (HCOs) to clinical research sites, along with the conversion of Healthcare Providers (HCPs) to Principal Investigators (PIs). These conversions are critical to advancing medicine and providing cutting-edge treatment to patients, but in the current clinical research landscape increasingly complex clinical trial protocols, demanding data collection requirements, and constricted study timelines have been stalling HCO and HCP conversion rates. The pace of clinical trials being initiated now exceeds the amount of clinical research sites available to conduct these trials.

Because of this, active clinical research sites have become saturated and are facing unrelenting pressure to meet protocol endpoints within the timelines dictated. With only 15% of HCOs conducting clinical research according to industry sources, sponsors and CROs must ensure existing study sites are fully enabled to conduct efficient studies so protocol endpoints can be successfully met. To do this successfully, sponsors and CROs must enable their study sites from the very beginning. Effective site enablement must address several key factors, including protocol design, training, participant recruitment and enrollment, and more.

How Sponsors and CROs Can Better Enable the Research Sites Conducting Their Studies

Over the past few years, clinical trials have become increasingly complex. When more than one clinical trial is available at a study site, sites tend to gravitate toward the trial protocol that provides ease in enrollment and retention with considerations to their bandwidth. By identifying potential enrollment barriers and challenges prior to study activation, sponsors and CROs can significantly optimize protocol design, decrease trial complexity, and boost study success. Reducing trial complexity should begin by providing study sites with a streamlined protocol design and a customized plan to engage desired participant populations.

Coupling protocol complexity with growing data collection requirements has resulted in an increased need to ensure adequate study site training, including the specialized training required to perform certain data assessments. Streamlined protocols can reduce the number of unnecessary data points, but the clinical trial endpoints needed to move treatments through FDA approval remain complex. Adequate training not only encompasses GCP and HIPAA, but also includes in-depth protocol training that is easily managed by sponsors and easily navigated by sites. This enables study teams to focus on the content of the training instead of the delivery of the training, ensuring the importance of the trial endpoints remains a top priority.

Having complex protocols with aggressive study timelines and demanding data collection requirements also increases the need for dedicated study support in order for sites to meet timelines. A strong study acceleration plan begins at site activation and continues through patient retention to data entry and query resolution. Every study site has their own complex needs, so it is critical to identify the needs of each site involved in a study so the recruitment and enrollment process can be enhanced. The development of a participant recruitment plan during the site activation process can ensure potential participants are identified quickly and enrollment is not delayed, while providing sites with additional support for administrative items like data entry and query resolution can help sites better meet study timelines.

How WCG Partners with Sponsors and CROs to Enable More Efficient Studies at Research Sites

Site enablement is critical to navigating today’s complex landscape of clinical research and requires a deep understanding of the study support required at study sites. Collaborating with organizations like WCG can provide sponsors and CROs with the Site Enablement solutions and support they need to ensure their study sites are enabled to conduct efficient and timely clinical research.

WCG’s Protocol Design solutions help optimize protocol design to avoid unnecessary amendments, improve trial predictability, and mitigate risk through data intelligence. WCG’s InvestigatorSpace® technology is designed to provide protocol training that is easy to navigate and track for sponsors and study sites, and can also accommodate specialized rater training, including rater qualification and certification for when trial protocols include the collection of data using scale assessments. WCG’s Enrollment and Retention solutions help study sites speed enrollment by developing customized site support and participant recruitment plans, while providing valuable study administration support to ensure patient retention, timely data entry, and query resolution.

Visit WCG’s website to learn more their Site Enablement solutions to better enable your study sites and conduct your studies as efficiently as possible.

The editorial staff had no role in this post's creation.