Clinical trials are a critical driver of progress in ophthalmology, and the demand for reliable, high-performing research sites continues to grow. For practices looking to diversify revenue, strengthen their reputation, or provide patients early access to innovative therapies, participating in clinical research can be a valuable strategic opportunity. This article outlines the key metrics that sponsors and clinical research organizations (CROs) use to evaluate and select research sites—and offers practical guidance for building a strong foundation as a trusted and sustainable research partner.
Why Site Selection Matters
Selecting the right research sites is not just a logistical decision, it’s a strategic one that directly impacts a study’s success. Underperforming sites introduce risks that can delay timelines, increase costs, and compromise data integrity. One immediate consequence is slow recruitment. When enrollment lags, study timelines stretch, requiring costly contract extensions, vendor re-engagements, and even activation of backup sites. These delays can ripple into missed internal milestones and unmet investor or market expectations, especially for therapies with accelerated approval paths. Ultimately, this means delays in bringing novel, safe, and effective therapies to patients in need. For many sponsors, success hinges on how quickly they can reach the market and whether they secure a first-to-market advantage.
Beyond recruitment, site underperformance can lead to data inconsistencies and inaccuracies, jeopardizing the approval of otherwise safe and effective therapies. Overwhelmed or under-trained staff may rush procedures or inadvertently enroll ineligible patients. In studies where endpoints like contrast sensitivity or BCVA depend on consistent technique, a handful of poorly executed assessments can erode the power to detect a treatment effect.
The FDA emphasizes that safety data must be timely and comprehensive. Incomplete or delayed documentation of adverse events increases regulatory scrutiny and can create the perception of an unreliable safety profile. These challenges also generate downstream operational burden: more queries, more data cleaning, and potentially more excluded data. When study quality suffers, trust in the results erodes, and even promising therapies may struggle to advance.
Most critically, site underperformance can affect a study’s ability to meet regulatory endpoints. Trials are statistically powered based on assumptions that a defined number of evaluable subjects will complete the study. If enrollment targets fall short or data are unusable, the study may miss the efficacy signal altogether. Regulatory agencies may also scrutinize data that originate from sites with inconsistent execution or limited experience. That’s why site selection is about more than location—it’s about operational maturity, training, and therapeutic expertise.
Being matched to the right study is key to long-term success. Honesty and accuracy in enrollment projections at a given site are critical to the timely success in overall study completion. Strategic alignment on both sides ensures the study runs efficiently, data are meaningful, and all parties benefit from a well-executed partnership.
The Key Metrics Sponsors and CROs Evaluate
To be recognized as a high-value partner, sites must understand how sponsors and CROs assess performance and align those expectations with their own operating model. Clarifying a strategy helps a site play to its strengths and become a repeat collaborator. Below are the key metrics sponsors and CROs assess when evaluating potential sites and how sites can strengthen each one.
Patient Database and Access
Among all site-selection criteria, access to the right patient population is one of the most decisive factors. Sponsors need confidence that a site can find eligible patients quickly, and a robust patient database specific to the indication, searchable by eligibility criteria, and reflective of actual volume signals readiness.
Urban, well-connected sites may benefit from high patient flow and referral opportunities, while rural sites may provide access to treatment-naive patients, particularly valuable in studies with prior-treatment exclusions. What matters is whether the site can demonstrate a reliable path to identify and engage the right population.
Sites can strengthen their position by sharing de-identified metrics from EMRs, such as diagnosis codes. The ability to stratify by age, comorbidities, or prior treatment history adds further value. Importantly, aligning with FDA guidance on diversity in clinical trials also gives sites a strategic edge. Those that serve underrepresented communities or maintain referral networks for diverse populations are increasingly prioritized by sponsors under new regulatory expectations.
A strong referral network is viewed as an indicator of success. If a practice is well known to a referral network and the qualifications for enrollment are made known to that network, enrollment can be accelerated. Sponsors want assurance that potential can be translated into performance.
Recruitment and Retention
Past recruitment performance is a leading indicator of future success. Sponsors want to know how a site has executed in studies with similar eligibility requirements or therapeutic areas. Context and transparency are critical here. If a site met its targets with the help of recruitment vendors or outreach programs, that’s not viewed negatively. Rather, it helps sponsors plan appropriately and replicate successful tactics. Understanding what resources contributed to performance provides a clearer forecast for the study ahead.
Retention is equally critical. Sites that can keep patients engaged through the end of the study are often those with strong clinical communication, careful scheduling, and a culture of patient-centered research.
Operational Reliability
Sponsors place strong emphasis on a site’s ability to follow the protocol and maintain high data quality. Sites that consistently minimize deviations, complete visits on time, and enter data promptly are viewed as low risk and operationally sound.
Data timeliness and accuracy are also scrutinized. Sponsors monitor how quickly data are entered into EDC systems, how many queries are generated, and how responsive the site is in resolving them. Delays, omissions, or excessive queries often point to gaps in training or oversight.
That said, sponsors aren’t expecting perfection. What matters is whether the site understands the protocol parameters and is making a deliberate effort to comply. Sites that demonstrate a consistent commitment to quality, even in the face of challenges, stand out more than those with isolated instances of clean data. It’s about patterns and mindset.
Investigator & Staff Experience
Operational reliability is often driven by experience. Investigators and coordinators with ophthalmic research backgrounds are better equipped to handle complex procedures, anticipate protocol nuances, and manage unexpected challenges. In trials with subjective assessments—like contrast sensitivity or BCVA—even slight inconsistencies can impact study outcomes. Experienced staff are more likely to deliver consistent, high-quality data.
Staffing is especially important in studies with masking or blinding requirements. Maintaining patient masking requires precision in patient communication, visit flow, and documentation. Sites familiar with these designs can uphold data integrity more reliably.
Sponsors often seek out investigators who can serve as partners in problem-solving. Whether it’s interpreting edge-case eligibility or navigating a protocol deviation, sites with clinical insight add value far beyond execution. While technical skills are essential, so is responsiveness. Sponsors value teams who are engaged, professional, and solutions oriented.
Building a Strong Site Profile
Being a high-performing site is only part of the equation; visibility matters too. Sites that present their capabilities clearly and professionally are more likely to stand out during feasibility or site selection. To build a strong profile:
Develop a site overview or performance portfolio: Include key metrics, recent studies, investigator experience, therapeutic focus areas, and recruitment capabilities.
Engage at industry events: Connect with sponsors and CROs at meetings, talks, symposiums, and conferences.
Invest in site infrastructure and technology: Adopt digital systems to improve startup speed and streamline documentation, and consider investing in equipment that would add value. Establish visibility amongst a referral network of comprehensive ophthalmologists and optometrists as a quality research facility to which they are comfortable referring their patients.
Demonstrate thought leadership: Join advisory boards, publish research, or contribute insights at webinars and roundtables.
These efforts communicate not just experience but also engagement—and that can differentiate a site when sponsors are choosing between otherwise similar options.
Shaping the Future of Clinical Research
Participating in clinical trials can strengthen a practice’s reputation, improve patient access to innovative therapies, and drive long-term growth. But to be consistently selected, sites must align with what matters most to sponsors and CROs: access to the right patients, demonstrated recruitment success, strong protocol execution, reliable data, and responsive, experienced staff.
In an increasingly competitive research landscape, being a strategic, capable, and collaborative site is the key to building sustainable research partnerships. OM
