Speeding Ophthalmic Trial Execution with an In-House Reading Center

Why working with an in-house reading center is crucial to ophthalmic trial success
By: Brittany Chung, Sr. Manager, Reading Center

While external reading centers are commonplace in most ophthalmology trials, for many companies, these services can drive up costs and threaten critical timelines. Outsourcing to external centers no longer works given the highly competitive and resource-constrained environments that companies now operate in. At Lexitas, we’ve been doing things differently – we run our own reading center in-house to streamline trial operations and improve outcomes for our clients. 

I’m Brittany Chung, Sr. Manager, Reading Center, and it’s my job to manage the Lexitas Reading Center. With experience in ocular research and clinical management, I make sure our clients receive the best image reading services when working with Lexitas. Below, I share more about the Lexitas Reading Center, and why this in-house approach helps companies avoid challenges common with external centers.

What are the challenges with third-party reading centers? 

We’ve seen from clients that working with third-party reading centers can cause significant delays in their study timelines, putting trial outcomes and budgets at risk. These delays can happen throughout the whole process – from certification and site startup through image review and data export. While some delays come from staffing issues at the reading centers, others happen due to mistakes during ocular image and endpoint analysis. Given the complex and specialized nature of ocular anatomy, reading centers depend on highly-skilled ophthalmology experts to perform reviews. But because these reading centers are contracted for only a portion of the study, their staff has to learn new and complicated endpoints for each client – without having visibility into the larger trial. This requires extensive training, which can slow turnaround times.

On top of this, working with third-party reading centers creates a significant administrative burden for our clients. They have to spend extra time and money finding, selecting, and validating the reading centers – which takes their focus away from other important trial activities. And, even after selecting a reading center, there’s no guarantee that the chosen company will provide a quality service. In fact, because third-party reading centers aren’t involved with study design or management, they sometimes fail to follow study protocols, which can undermine accurate analysis. It’s an ongoing challenge that we see over and over again in our studies. 

How does the Lexitas Reading Center offset these challenges? What are the other benefits of using an in-house reading center? 

At Lexitas, we provide a modern approach to reading centers. Instead of using external reading centers like other CROs, we offer these services in-house, fully integrated with our other CRO offerings.  Centralizing trial processes and fees within a single partner helps our clients reduce overhead and avoid delays that they often experience with external reading centers. 

Throughout the entire trial partnership, we prioritize speed and collaboration with our clients. We review images within five to seven days and work closely with our data management team to regularly reconcile data. This makes it easy to generate queries, and our standard data formats streamline data integration across teams. To get sites up and running quickly, we work closely with the Lexitas study team on training, equipment needs, and planning site certification around SIV visits.

Including reading center services as part of our full CRO offering offers some unique advantages over third-party centers and other CROs. In-house reading centers help simplify document preparation by keeping everyone aligned, from reading center staff to data management and biostatistics teams. Bringing everything together under one company really simplifies vendor management and reduces complexity for our clients.

When it comes to trial execution, in-house reading centers help align ClinOps and Medical Writing teams. And, working with an ophthalmology-focused CRO and reading center guarantees that all involved have deep ophthalmology experience. Sponsors get access to ophthalmic specialists with expertise across pathologies such as Diabetic Macular Edema (DME), Conjunctival Redness, Dry Eye Disease, Neurotrophic Keratitis, Rhegmatogenous Retinal Detachment, Age-related Macular Degeneration (Wet and Dry), and more. It’s a significant advantage.

How can companies work with the Lexitas Reading Center?

When working with the Lexitas Reading Center, customers have two options. They can partner with us on end-to-end trial management, which includes our in-house reading services. When our clients are already working with another CRO on study management, they can still use our reading center services standalone. No matter how we support our customers, we always offer comprehensive reading center services, from site training and startup to image quality review and reporting. In all of our client engagements, we strive to provide the best service possible for our customers and their trials. We are happy to customize reading center services to align with customer needs in areas like site certifications, project management, reader selection, data reconciliation, and more.

With our extensive CRO experience, we know how important endpoints are for trial success. A key component of our reading center service is comprehensive endpoint training, which spans the entire reading center process. The Lexitas Reading Center also offers virtual training sessions and training videos, and we work with a pool of SMEs to properly certify equipment and train technicians. All of these activities are crucial to ensuring high image quality and accurate endpoint analysis.

How do we ensure high-quality output from our reading center? 

We’re committed to delivering the highest quality service for our clients. We focus heavily on compliance before, during, and throughout the reading center process, and are SOC 2 Type 1, 21 CFR Part 11, and GDPR compliant. Before study startup, each site goes through an extensive certification process. And, we work closely with study teams to set up and order necessary equipment so we can collect accurate data. Once reading center services begin, we use a pre-read quality control (QC) process to make sure images are acceptable and readable. When needed – and especially for primary and secondary endpoints – our readers will help approve images. 

To streamline trial and document management, we use technology like iNebula clinical management system and Orion analysis software. This provides our clients with a centralized electronic source of truth and overview of their trial from any device, at any time. And, customers always get access to validated and verified document packages and fully traceable audit trails. 

What is Lexitas experience in the ophthalmology space?

We’re well known in the industry for our 12+ years of experience focusing entirely on ophthalmic clinical studies across all phases. From these studies, we’ve developed a detailed set of Standard Operating Procedures (SOPs) that provide a validated best practices framework for each study. Our reading center has operated for a number of years now, and our dedicated staff have extensive experience running reading centers and analyzing images.

The Lexitas Reading Center offers a variety of anterior and posterior multimodal imaging services, customized to our client’s needs. These include Anterior Segment Optical Coherence Tomography, Confocal microscopy, Ocular Coherence Tomography Angiography (OCTA), and much more.

Lastly, what sets us apart is our focus on building lasting partnerships with our clients and with our sites. We believe strong relationships are key to successful trial outcomes. Our reputation and high referral rates show that our clients trust us to deliver quality CRO and reading center services. 

Interested in learning more about the Lexitas Reading Center? Contact us to see how we can help you cover your imaging needs.