Site Selection

Finding the right sites is one of the most crucial steps in the timely completion of a clinical study. The site must be capable of conducting the study with access to the eligible patient population, a thorough understanding and belief in the study rationale, as well as commitment to the study by keeping it 'top-of-mind'. One aspect of our ACT service is the analysis of existing sites and the selection of new sites for the study. DAVA prides itself on critically analyzing sites as well as choosing sites that can be reliable recruiters for the study.

After careful review of the requirements of the study protocol, we target sites using our proprietary database. The database has the profile of all the investigators that participate in clinical studies along with their education, experience, practice setting, membership in network organization and activity in clinical trials in protocol-specific tumor type. With this information as well as our experience with the sites with previous studies, we finalize the list of 'potential sites'.

We further analyze these sites and evaluate their capabilities by answering some of the site-specific questions mentioned below:

• Does the site currently have active clinical trials in the specific tumor type? If so, how many?
• Does the site have one location or multiple locations for clinical trials?
• How many medical oncologists regularly treat patients at the site?

All these questions are discussed by our medical oncologists during direct MD to MD interactions either via a phone call, site visit or email. During this analysis, the study rationale along with any potential hurdle to the protocol is discussed. We also ensure that the site is free of any FDA warnings.

Once a site expresses interest in the study and our medical oncologists feel comfortable about the site's capabilities and resources to conduct the study, we work with the sites in completing the study-specific confidentiality agreement (CDA) and feasibility questionnaires. We also assist the CRAs and the CRMs with scheduling the pre-selection or pre-qualification visit with the sites. Our medical oncologists along with our clinical trial specialists assist with any bottleneck that might arise while scheduling this visit and also help by answering any question the research staff might have.