Site Feasibility & Selection

Selecting qualified clinical sites and investigators is a critical factor in the successful execution of a clinical trial. A well-designed site feasibility and selection strategy helps sponsors assess whether potential sites have the appropriate patient population, investigator expertise, infrastructure, resources, and operational capabilities to meet study requirements.

Protheragen provides comprehensive Site Feasibility & Selection services to help sponsors identify and prioritize suitable investigational sites based on protocol requirements and study objectives. Our approach combines clinical operational expertise, therapeutic knowledge, site-level information, investigator experience, patient access, and recruitment considerations to support informed site selection decisions.

Introduction to Site Feasibility & Selection

Clinical trial site selection is a critical component of study planning and can significantly influence patient recruitment, study timelines, data quality, and overall trial execution. Before initiating a clinical study, sponsors need to determine whether potential sites have the appropriate investigators, patient populations, facilities, research resources, and operational capabilities to meet protocol requirements.

Site feasibility provides a structured assessment of a site's ability and readiness to conduct a specific clinical trial. Rather than evaluating sites solely on their institutional reputation or previous experience, a comprehensive feasibility assessment considers multiple factors, including investigator qualifications, therapeutic expertise, patient availability, recruitment potential, competing studies, site infrastructure, research staffing, regulatory experience, and operational capacity.

Site selection builds on these feasibility findings to identify and prioritize the sites and investigators that are best aligned with the study's objectives. By comparing candidate sites against predefined criteria, sponsors can identify potential operational and recruitment risks early, establish realistic enrollment expectations, and develop a more effective site network.

Figure 1. Diagram showing one emerging trend in Site Feasibility, the early initiation of the Site Feasibility process. (Bruneau B, et al., 2024)

Our Services

Protheragen provides two complementary services to support sponsors from initial feasibility evaluation through site recommendation.

Key Areas of Site Feasibility Evaluation

• Investigator Qualifications & Experience

Investigator expertise can directly influence study execution and patient recruitment. Protheragen evaluates investigator qualifications, therapeutic experience, previous clinical trial participation, protocol experience, and availability to support the study.

• Patient Population & Recruitment Potential

We assess whether candidate sites have access to an appropriate patient population and evaluate potential recruitment capacity based on disease characteristics, eligibility criteria, referral resources, historical enrollment, and competing studies.

• Site Infrastructure & Resources

Potential sites are assessed for clinical facilities, equipment, laboratory capabilities, research personnel, documentation systems, and other resources required by the study protocol.

• Therapeutic Area Capabilities

We consider the site's experience in the relevant therapeutic area and its familiarity with the disease, patient population, clinical procedures, and treatment characteristics involved in the study.

• Previous Clinical Trial Experience

Historical experience provides important insight into a site's ability to execute clinical studies. We consider previous trial participation, study types, therapeutic areas, recruitment performance, and experience with similar protocols.

• Operational Readiness

We evaluate the site's available personnel, workload, study timelines, communication capabilities, and overall readiness to initiate and conduct the proposed clinical trial.

• Regulatory & Ethics Experience

Site experience with ethics committee/IRB interactions, regulatory submissions, essential documentation, and clinical research requirements is considered when assessing overall site readiness.

Site Feasibility & Selection Process

Site & Investigator Selection Criteria

Why Site Feasibility & Selection Matters

Why Choose Protheragen

• Extensive experience across multiple therapeutic areas and study phases
• Structured and data-driven feasibility methodology
• Strong understanding of global and regional site landscapes
• Access to established investigational site networks
• Risk-based evaluation and decision-making framework
• Transparent reporting with clear comparative insights
• Focus on recruitment efficiency and study success metrics

The success of a clinical trial begins with selecting the right investigational sites. Effective feasibility assessment and site selection not only improve patient recruitment and study quality but also reduce operational risks and accelerate study timelines. By combining local market knowledge, clinical research expertise, and a structured evaluation methodology, Protheragen helps sponsors identify high-performing sites that are well-positioned to meet study objectives and regulatory requirements. Contact us to discuss your project requirements and learn about our site feasibility & selection services.