Site selection is one of the most important steps in the clinical trial process; nevertheless, it can be the most daunting. With over 272,000 registered clinical trials worldwide, finding respectable and high-quality sites can be a huge challenge. Taking a step back from the typical site enrollment capabilities and looking at other qualities a site possesses can help to define the framework of a quality site.
While many qualities can be vital for selecting a site, the organizational structure of a site lays the groundwork for selecting a quality site. Ensuring that the site has been built on a sound infrastructure to support the clinical trial can make all the difference when determining the quality of the site. Although the organizational infrastructure can vary among sites depending on therapeutic areas and indications, Biorasi has recognized this quality among all highly performing sites. We realize that all studies vary in the degree of requirements outlined in the synopsis or protocol; however, at the very least sponsors and CROs need to make sure the site has necessary personnel to conduct a study. Utilizing a site that is not equipped for the clinical study can lead to an increase in the original costs, prolonged start-up timelines and an increase in the overall study timeline. Focusing on the organizational structure can help to narrow down the sites and ensure that the utmost quality sites are selected.
Density of the patient population in the area that surrounds the site is another factor that can determine if the site is going to perform well in a particular study. During the site selection process, it is very important to know that the Principal Investigator (PI) will have access to the patient population. This can be done through their own database or through colleagues in the area so that patients do not have to travel far for the study. Additional resources can be accessed to check for an adequate patient population – reports from the CDC, journal articles in medical publications, and similar. For unusual or difficult to recruit trials, it may make sense to examine even more distantly related material to identify regional or local features that may increase the likelihood of finding patient clusters – nearby infrastructure projects like Superfund sites or factories, or perhaps local population clusters that are particularly prone to certain conditions.
Having a sound infrastructure and access to the patient population are very important objective qualities, but only tell part of the story. Biorasi has also found that the underlying qualities that make for consistent, high quality sites are communication and responsiveness. For many CROs, subjective skills may be overlooked during the site selection process. However, we place an emphasis on the importance of soft skills during the site selection process to aid in the selection of sites that will perform well. Focusing on soft skills, especially communication and responsiveness, have helped to align outstanding sites with satisfied sponsors.
Communication is a crucial component as it tends to be the driving force throughout the life of a study. Boundless site communication sets the study up for on-time deliverables, accurate completion of documents and transparency. Biorasi focuses on these soft skills to ensure precise turnaround time during the CDA execution process, completion of the study specific feasibility questionnaire and the flexibility of scheduling the site selection visit (SSV). These qualities at the very beginning show dedication and commitment to the study from a site.
Uncovering imperative objective and subjective skills such as infrastructure, communication and quality help Biorasi to identify outstanding sites. Putting an emphasis on these qualities, rather than just enrollment capabilities, will help to hand-pick quality sites that are to ensure the overall success of the clinical trial.