Site Relationship Challenges Across
the Industry
Site relationship management is challenging no matter what, whether managing dozens of sites for a global trial with tight enrollment timelines, providing support and training for complex molecules, or building site-specific patient pathways. Understanding each site’s pain points is often a monumental task since it requires a highly tailored approach, yet doing so is essential to overcoming these obstacles. It’s likely many CROs neglect this critical step due to what is often perceived as a time-consuming and costly process.
In addition to hands-on experience, there is a growing body of existing data from sites to help sponsors and CROs make more effective decisions about site support from the beginning. Sites report similar challenges throughout the clinical trial process, including:
1. Lack of Resources: In a recent survey, sites identified staffing, study budgets, and protocol complexity as the top areas that have become increasingly difficult over the last five years.2 Specific challenges sites may encounter in the current clinical trial landscape include navigating vendor arrangements, the impact of the COVID-19 pandemic, and addressing regional conflicts that affect normal operations and the patient population.
2. Lack of Communication: Sponsors often wonder what they can do to help sites struggling to meet patient enrollment goals. While the answer may seem simple, executing it is anything but: communication. Establishing clear lines of communication and providing the space for open conversation and feedback, including regular calls and face-to-face meetings to address questions and concerns, helps sites mitigate waste and handle change management more effectively. In addition, sites consistently mentioned a lack of communication before, during, and after the close of a trial as directly, impacting their optimism and willingness to work with a sponsor or CRO again.3
3. Lack of Training and Support: CROs and sponsors should aim to create as seamless an experience as possible for sites. Many sites have shared that they often feel they are participating in a “pilot” mode where sponsors or CROs are testing new combinations of technology tools or processes without consistency across the organization or even the therapeutic team, often leading to additional workflow disruption due to retraining and unfamiliarity.2 A lack of support during trial operationalization, including training on study design (and redesign), budgets, and data management and handling, can add further complexities.
