In this article, VP of Operations Ryan Kaiser and Director of Clinical Operations Cathy Babineaux discuss their top considerations for sponsors selecting an ophthalmology CRO.

Selecting the right contract research organization (CRO) is crucial to the success of any clinical trial, especially in a field as specialized as ophthalmology. Your chosen CRO will impact your study’s budget, timeline, and data quality, ultimately affecting your ability to get a drug, device, or other therapeutic to patients in need. The unique demands of ophthalmic clinical trials require partnering with a CRO that provides tailored solutions to address each study’s unique needs, with a deep understanding of the delivery route and indication. Trustworthy insights into enrollment strategy and protocol design are key to driving successful outcomes.

Here are five key variables to consider when evaluating a CRO for an ophthalmic clinical trial:

1. Ophthalmology Expertise and Focus

A focus on ophthalmology is a critical factor when selecting a CRO for an ophthalmic clinical trial. The partner you choose should have experts with specialized knowledge who are involved in the evolving industry landscape, medical and scientific innovations, and the latest developments.

The experience of an ophthalmic CRO should span across all major segments and indications, with deep knowledge of specialized assessments and the importance of imaging as it relates to study endpoints. Clinical research associates (CRAs) and medical monitors with dedicated and often life-long experience in ophthalmology will lead to better efficiency and a more positive experience for the sponsor, sites and patients. CRAs that are well-versed in ophthalmology will reduce the burden on site staff by anticipating site needs, eliminating unnecessary questions, and avoiding errors that stem from a lack of therapeutic understanding. This level of expertise helps reduce the risk of delays and ensures smoother trial execution.

Additionally, a CRO focused on ophthalmology is more likely to know which sites are the best fit for a specific study—those with a proven track record of performance, patient recruitment, and protocol adherence.  Having a significant number of staff on your operations team who come from site and clinical backgrounds within ophthalmology also provides a better understanding and perspective of what is needed for sites and, ultimately, patients.

2. Size and Tailored Support

CROs vary widely in size and structure, with different models offering unique benefits and challenges. One of the primary advantages of working with a specialized CRO is its ability to be more flexible and provide improved service with fewer layers of red tape. In smaller organizations, management is often more aware of and regularly involved in innovations within the industry (e.g., endpoints), supporting projects, delivery teams, and site and customer relationships. This hands-on approach ensures that issues are addressed promptly and that there is closer collaboration with sponsors. At Lexitas, we’re lucky to have executives and senior leaders who are readily available to help our customers with introductions to KOLs, share recent advances in endpoint development, and understand the regulatory pathway towards approval. This leads to a more hands-on approach to trial management, which ultimately benefits the overall success of the study.

Cost is always a significant factor when selecting a CRO, value goes beyond just the bottom line. Working with a CRO who offers competitive pricing with clear cost breakdowns, flexibility in budget adjustments, and transparent contract terms is crucial for confident financial planning. Additionally, the flexibility in budget adjustments ensures that the study can adapt to any unforeseen changes without compromising on quality or timelines. This agility is another benefit of working with a smaller CRO and can make all the difference.

3. Site Relationships

CROs with strong site relationships can streamline the site selection process, which is crucial for the success of ophthalmic trials. One advantage of a strong site network is understanding who the key opinion leaders (KOLs) are in different areas of ophthalmology. At Lexitas, we have a network of more than 700 sites, and our deep familiarity with KOLs and strong relationships with site staff allow us to leverage these connections to drive delivery and strategy. Knowing which sites have the necessary infrastructure and the ability to understand specific ophthalmic assessments is essential.

Data on sites and their capabilities, strengths, and cost expectations should be captured in the CRO’s clinical trial management system (CTMS). This includes information on site performance, patient recruitment rates, and historical trial outcomes. Having this database leads to better-informed decision-making around enrollment projections and recruitment potential in many indications.

4. Technology and Resources

Using the right technology and equipment is essential for maintaining compliance and efficiency. A CRO with strong, established relationships with preferred equipment and technology vendors can recommend the right solutions for your study and ensure you have the tools needed for accurate, reliable data collection. Additionally, preferred consultancy relationships specializing in ophthalmology (medical, regulatory, statistics, etc.) further enhance the CRO’s ability to deliver high-quality results.

Additionally, a CRO with an integrated in-house reading center can deliver added technology and accessibility benefits to enhance the efficiency of your study. The Lexitas Reading Center offers a device-agnostic platform with real-time data access, streamlining image review and enabling faster, more informed decision-making throughout the trial.

5. Enrollment Experience and Strategy

Patient enrollment is arguably the most important part of a clinical trial. CROs with a thorough understanding of your target indication and patient population will be able to help you build an enrollment strategy that will be tailored and effective for your study. For larger studies, enrollment strategies may lean more heavily on industry averages; however, for smaller or more specialized studies, a CRO’s relationships with clinical trial sites and deep knowledge of the therapeutic area become even more essential.

At Lexitas, we leverage a combination of long-standing site partnerships, targeted outreach strategies—including collaborations with specialized vendors for rare and complex ocular conditions—and patient-centric engagement approaches to drive strong enrollment performance. We recognize that every protocol has unique requirements and, therefore, prioritize tailoring recruitment strategies to each study’s specific needs. This includes conducting detailed feasibility assessments to select the most appropriate sites, understanding the unique patient pathways for the indication, developing customized recruitment materials, and providing proactive, white-glove support to our sites.

Additionally, we utilize both internal enrollment data from previous ophthalmic studies and broader industry data to inform our strategies, ensuring our decisions are grounded in real-world performance metrics. By combining these elements, we help ensure that studies stay on track and enrollment goals are met as efficiently and effectively as possible.

Choosing the right ophthalmology contract research organization is a significant decision that affects every aspect of your trial. By evaluating the agility, technology, relationships, and, most crucially, the expertise of the CRO, sponsors can ensure that their ophthalmic clinical trials are well-managed. At Lexitas, our customizable approach, expertise, and extensive site relationships ensure that each trial is run with quality and efficiency. Bringing new treatment options to patients starts with selecting the right partner—one who understands the path to success and is equipped to navigate it with you.

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