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For sponsors in ophthalmic clinical trials, looking beyond traditional U.S.-based labs for retinal-image adjudication unlocks a world of strategic advantages. A global ecosystem of Outside-the-US (OUS) reading centres offers accelerated timelines through a 24-hour "follow-the-sun" model, superior economics with costs often 25-50% lower than U.S. averages, and enhanced data integrity by aligning graders with diverse patient populations. These international hubs, from Europe's scientifically rigorous centres like Moorfields and the EVICR.net network to Asia-Pacific's powerhouses of speed like Singapore's SORC, provide fully compliant services accepted by the FDA and EMA. Latin America, in particular, presents a compelling value proposition, with centres like Mexico's Instituto de la Visión offering a bilingual team, competitive costs, and a proven regulatory pathway through the PACORES research network. By strategically sourcing these global partners, sponsors can significantly enhance trial efficiency, reduce budgets, and speed sight-saving therapies to market.
The success of modern ophthalmic clinical trials lives or dies on the quality, integrity, and speed of independent image adjudication.1 For any therapy targeting retinal disease, from diabetic retinopathy (DR) to age-related macular degeneration (AMD), the meticulous analysis of retinal images—such as color fundus photography (CFP), optical coherence tomography (OCT), and fluorescein angiography (FA)—provides the objective evidence of a treatment's safety and efficacy. This process, known as retinal-image grading or adjudication, is a non-negotiable cornerstone of regulatory submissions to bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
For years, many biopharma and medical device sponsors have defaulted to U.S.-based core labs and contract research organizations (CROs) to perform this critical function. This traditional approach, however, often overlooks a vibrant and rapidly maturing global ecosystem of first-class retinal-image reading centres located outside the United States (OUS).1 Across Europe, the Asia-Pacific region, and Latin America, a new generation of adjudication centers—many embedded within world-renowned academic institutions and national health systems—offers scientifically rigorous, regulatory-compliant services that present compelling strategic advantages.
The decision of where to place a reading center is no longer merely a logistical choice; it is a core strategic decision that can profoundly impact a trial's budget, timeline, and even the scientific validity of its data. Forward-thinking sponsors are discovering that a global sourcing strategy for image adjudication can unlock significant efficiencies, accelerate development timelines, enhance data quality, and optimize resource allocation.
This report serves as an exhaustive guide for clinical trial sponsors, mapping the leading OUS retinal-image adjudication centres and their unique capabilities. It provides a detailed analysis of the strategic rationale for looking beyond U.S. borders, offers a region-by-region tour of premier global hubs, and equips sponsors with a practical due-diligence framework for selecting the ideal partner. By understanding the global landscape, sponsors can move from a default choice to a strategic one, gaining a decisive competitive advantage in the race to bring sight-saving therapies to patients worldwide.1
The consideration of an OUS reading center is driven by a powerful convergence of operational, scientific, economic, and regulatory advantages. These are not minor, incremental benefits; they represent fundamental improvements to the clinical trial process. An analysis of these drivers reveals why a global strategy for image adjudication has become a strategic imperative for sponsors aiming to optimize their ophthalmology programs.
In clinical trials, time is the most valuable and inelastic resource. OUS reading centers offer a powerful mechanism for compressing trial timelines through a 24-hour "follow-the-sun" operational model.1 This approach transforms image grading from a linear, start-and-stop process into a continuous, uninterrupted workflow.
The mechanics are straightforward but transformative. As the clinical day ends for sites in the Americas, retinal images can be securely uploaded to a reading center in the Asia-Pacific region where the workday is just beginning. Graders at centers like the SNEC Ocular Reading Centre (SORC) in Singapore can adjudicate these images overnight (from a U.S. perspective), providing feedback and resolving queries before the American sites come back online. This continuous loop eliminates the dead time inherent in a single-time-zone model, effectively doubling the productive hours in a day.
The impact on timelines is significant. Leading OUS labs in Europe and Asia-Pacific commit to aggressive Service Level Agreements (SLAs), often delivering safety reads within 24 to 48 hours and masked efficacy endpoint reads in ten days or less.1 This rapid turnaround is particularly critical for safety monitoring, allowing for near-real-time review of adverse events, and for adaptive trial designs, where quick data analysis can inform crucial protocol adjustments. By leveraging a global network, sponsors can dramatically shorten the window from the last image captured to the final database lock, accelerating the entire submission process.1
The globalization of clinical trials, with patient recruitment spanning multiple continents and diverse ethnic populations, has introduced a subtle but significant scientific challenge: potential bias in image interpretation. Retinal pigmentation, fundus appearance, and even the manifestation of certain pathologies can vary across different ethnic groups. Relying on a homogenous group of graders, typically from a single Western country, to interpret images from a globally diverse patient pool can introduce unconscious bias and reduce the nuance of the analysis.1
OUS reading centers offer a direct solution to this challenge. A strategic approach aligns the geographic and ethnic background of the graders with that of the trial participants. For a study enrolling heavily in China, utilizing the bilingual English-Mandarin team at Singapore's SORC or the experts at the Zhongshan Image Reading Centre (ZIRC) in Guangzhou ensures that images are interpreted by graders intimately familiar with the retinal characteristics of that population.1 Similarly, for trials across Latin America, leveraging the Spanish-speaking graders at centers like the Instituto de la Visión in Mexico provides a level of cultural and physiological concordance that can enhance accuracy.1
This mirroring of grader and patient populations is not a trivial matter. It strengthens the scientific validity of the dataset, reduces the potential for queries related to ethnic-specific anatomical variations, and ultimately builds a more robust and defensible data package for regulatory review. It represents a commitment to scientific rigor that goes beyond simple metrics of cost and speed.1
A primary and compelling driver for considering OUS reading centers is the significant cost savings they can offer without compromising quality. Analysis shows that many leading OUS centers, by virtue of being embedded within university hospitals or national health service networks, can operate with overheads 25-40% below the rates of typical U.S.-based commercial CROs.1
This cost advantage is structural, not a reflection of lower standards. Academic centers like Moorfields Eye Hospital in the UK 2, the University of Coimbra in Portugal (home to CORC) 3, and the University of Cologne in Germany (home to CIRCL) 4 often benefit from subsidized infrastructure, shared administrative resources, and a mission that prioritizes research alongside clinical care. This economic model allows them to provide world-class services at a more competitive price point.
Furthermore, the pricing models themselves can offer strategic advantages. European academic centers often price on a per-image-set basis, with typical fees ranging from €18 to €25.1 In contrast, some Latin American labs, including the Instituto de la Visión, quote on a per-visit basis, with rates around US $12–$15. For study protocols that require multiple imaging modalities (e.g., CFP, OCT, and FA) at each visit, a per-visit fee structure can yield substantial savings, potentially 30-50% lower than U.S. averages.1 This allows sponsors to allocate budget more efficiently, either by reducing overall trial costs or by reinvesting savings into other critical areas like patient recruitment or additional exploratory endpoints.
The most critical question for any sponsor is whether data generated by an OUS reading center will be accepted by major regulatory authorities like the FDA and EMA. The evidence provides a clear and resounding "yes," thanks to the establishment of robust, internationally recognized quality frameworks and networks.
In Europe, the European Vision Institute Clinical Research Network (EVICR.net) is a key organization that harmonizes Standard Operating Procedures (SOPs) across its member sites, which include premier reading centers like CORC in Portugal and CIRCL in Germany. These centers are audited against stringent EMA and ISO 14155 standards for clinical investigations, ensuring their data meets the highest international quality benchmarks.1
In the Asia-Pacific region, leading centers such as SORC in Singapore adhere to both the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) guidelines and the rigorous standards of Singapore’s Health Sciences Authority (HSA). These standards are well-established and recognized by the FDA, providing a clear pathway for the inclusion of data from Asian sites in U.S. regulatory submissions.1
Similarly, in Latin America, the Pan-American Collaborative Retina Study Group (PACORES) has been instrumental in standardizing research quality. This network of 19 elite centers across 13 countries follows identical, high-quality grading manuals and has a proven track record of supplying datasets that have been successfully included in U.S. New Drug Application (NDA) submissions.1 The existence of these networks means that sponsors are not just contracting with a single entity, but are plugging into a pre-validated, regulatory-compliant ecosystem, significantly de-risking the use of OUS data and providing confidence in its global acceptance.
The global landscape of OUS reading centers is a diverse ecosystem with distinct regional specializations. Understanding these strengths allows sponsors to move beyond simple outsourcing and engage in strategic sourcing, aligning their trial's specific needs with the unique capabilities of a particular region or center.
Europe is home to some of the world's most established and scientifically advanced reading centers, characterized by deep regulatory experience, strong academic affiliations, and leadership in technological innovation.
Based at the world-renowned Moorfields Eye Hospital and its academic partner, University College London (UCL), the Moorfields Ophthalmic Reading Centre is arguably Europe's most prestigious adjudication hub.1 With a history of ophthalmic excellence dating back to 1805, Moorfields offers unparalleled scientific depth.9 The reading center's core function is to provide high-quality, SOP-driven, and unbiased image grading for clinical trials across a wide spectrum of modalities, including CFP, OCT, OCT-Angiography (OCT-A), ultra-widefield (UWF) imaging, and fluorescein/indocyanine green angiography (FA/ICGA).1
What distinguishes Moorfields is its pioneering role in the application of artificial intelligence (AI) and deep learning to ophthalmic imaging. Leveraging one of the world's largest archives of ophthalmic data, the center is at the forefront of developing automated segmentation tools, predictive analytics, and novel digital biomarkers.2 This makes Moorfields an indispensable partner for sponsors conducting complex, first-in-class trials or those developing their own AI-based diagnostics. Its involvement in pivotal studies like the UK Biobank and a track record of successful FDA/EMA inspections solidify its position as a go-to choice for trials demanding the highest level of scientific input and regulatory assurance.1
NetwORC UK represents a unique and powerful network model, combining the resources and expertise of three leading UK institutions: the Belfast Ophthalmic Reading Centre (BORC) at Queen’s University Belfast, the Liverpool Ophthalmic Reading Centre (LORC) at the University of Liverpool, and Moorfields.1 This consortium structure provides sponsors with several key advantages.
The primary benefit is immense, scalable capacity with built-in redundancy. By distributing the workload across three labs operating under harmonized SOPs, the network can deliver 24/7 grading services and handle very large image volumes without creating a single point of failure.1 Each node brings its own strengths: BORC provides expert grading, trial management, and academic leadership; LORC has deep experience in a wide range of retinal diseases and AI research; and Moorfields contributes its world-leading expertise.12 For sponsors running large, long-term global trials, the NetwORC UK model offers an unmatched combination of capacity, consistency, and risk mitigation.
The Coimbra Ophthalmology Reading Centre (CORC) and the Cologne Image Reading Center and Laboratory (CIRCL) are cornerstone members of the European Vision Institute Clinical Research Network (EVICR.net).1 This membership is a critical quality mark, as EVICR.net enforces harmonized, high-quality SOPs that are audited against EMA and ISO 14155 standards, ensuring a uniform level of excellence across the network.1
CORC, based at the University of Coimbra, is a founding member of EVICR.net and possesses extensive expertise in AMD and glaucoma. It is notable for grading a wide array of modalities, including functional tests like electrophysiology, in addition to standard imaging techniques.1 CORC also serves as the central reading center for Portugal's national DR screening program, demonstrating its capacity for high-volume, systematic grading.16
CIRCL, located at the University Hospital of Cologne, is renowned for its efficiency in fast-turnaround macular studies and its experience as the central reading center for numerous international Phase II, III, and IV clinical trials.1 It maintains a robust quality management system, with an ISO 27001-certified IT department, and explicitly states its adherence to Good Clinical Practice (GCP), providing sponsors with clear, documented evidence of its regulatory compliance.4 For sponsors conducting multi-center trials in the EU, leveraging the EVICR.net framework through centers like CORC and CIRCL provides a streamlined, regulatory-compliant pathway.
The Asia-Pacific region has emerged as a hub for highly efficient, large-scale reading centers that are particularly adept at managing high-volume diabetic retinopathy trials and studies focused on Asian populations.
Operating within the Singapore National Eye Centre (SNEC), a facility that manages over 353,000 outpatient visits annually, SORC is a powerhouse of efficiency and scale.17 Its primary role is to perform the centralized grading for Singapore's national diabetic retinopathy screening program (SiDRP), a cost-effective and time-efficient national health solution.1
For clinical trial sponsors, SORC offers a compelling suite of capabilities. It provides clinical trial-standard reading services for DR, AMD, glaucoma, and cataracts, with strict quality assurance and certification of photographers and equipment.6 Its key differentiators are its operational speed, with reporting timelines under 48 hours, and its fully bilingual (English-Mandarin) team of graders.1 This makes SORC an ideal partner for trials with sites in Southeast Asia and Greater China, as it eliminates language barriers and accelerates communication. Furthermore, SORC has developed its own proprietary analysis software, SIVA (Singapore “I” Vessel Assessment), demonstrating its in-house technological expertise.1
Also located in Singapore, the Fundus Image Reading Centre (FIRC) is part of the National Healthcare Group Eye Institute and is staffed by fellowship-trained retinologists, ensuring a high level of clinical expertise.1 FIRC has a proven track record in managing complex, multi-country Asian trials, having served as the central reading center for landmark studies like EVEREST and EVEREST II, which focused on polypoidal choroidal vasculopathy (PCV), a condition highly prevalent in Asian populations.1
FIRC provides a full suite of services, including the development of customized imaging and grading protocols, certification of site photographers, and secure archival of images.19 Its deep experience with pan-Asian clinical trials makes it a strategic choice for sponsors investigating therapies for diseases with a strong prevalence in the region.
The Zhongshan Ophthalmic Center (ZOC) is one of China's most prestigious eye hospitals and home to the country's unique State Key Laboratory of Ophthalmology.20 In 2015, ZOC established its Image Reading Centre (ZIRC) in a formal partnership with the Doheny Eye Institute, a world-leading U.S. reading center.22 This collaboration signaled a significant commitment to adopting global best practices and quality standards.
ZIRC's most notable strength is its position as the gold-standard reference for the rapidly growing market of AI-based diabetic retinopathy screening devices in China.1 For any sponsor, whether a global pharmaceutical company or a local med-tech innovator, looking to develop, validate, or gain regulatory approval for an AI diagnostic in the vast Chinese market, partnering with ZIRC is virtually essential. It offers unparalleled local expertise, regulatory credibility, and access to a vast, relevant patient population.
Latin America is rapidly establishing itself as a high-value destination for clinical research, offering a unique combination of cost-efficiency, speed, and access to large, treatment-naïve patient populations. The region's reading centers are characterized by their agility and expertise in innovative, cost-effective care models.
The Association to Prevent Blindness in Mexico (APEC) is a respected non-profit institution with a century-long history of providing eye care.23 Its clinical research arm at the "Hospital de la Ceguera" is a hub for trials in retina, glaucoma, and cataract research.23 APEC's diabetic retinopathy program is particularly innovative, focusing on tele-retina and mobile health solutions, such as using smartphone-based "fundus-on-phone" technology for screening.1
Crucially, APEC has developed and validated its own deep-learning AI system for DR triage, which has demonstrated a sensitivity of ≥95% in classifying referable versus non-referable cases.1 This positions APEC as a leader in developing and implementing cost-effective, AI-driven screening models that are ideal for large-scale population health studies or for trials conducted in decentralized or resource-constrained settings.
EyePACS-MX is the Mexican arm of the broader EyePACS network, a pioneering telemedicine system for diabetic retinopathy screening developed at the University of California, Berkeley, by Dr. Jorge Cuadros.1 The system operates on a license-free, web-based platform that simplifies the entire process of image capture in primary care settings, secure transmission to a central server, and remote review by certified graders.27
The EyePACS-MX network leverages this highly scalable and adaptable model to provide DR screening in clinics across the state of Guanajuato and beyond.1 Adhering to a standardized grading protocol based on the ETDRS classification, the network promises image reading within 48 hours.1 This distributive, cloud-based virtual system represents an excellent model for sponsors looking to incorporate retinal screening into large, decentralized primary care trials or population health studies in Latin America.
PACORES is not a single reading center but rather a highly influential and prolific research consortium that unites 19 elite ophthalmology centers across 13 countries in Latin America.1 Founded in 2006, PACORES was created to elevate the quality and volume of collaborative retinal research in the region. It has been remarkably successful, publishing more than 40 papers in major peer-reviewed journals, making it one of the most productive multicenter ophthalmology groups in the world.8
The significance of PACORES for sponsors is immense. The network ensures that its member sites, which can provide central grading services, all adhere to a uniform, high-quality protocol based on identical grading manuals.1 This creates a harmonized quality system across the continent. Most importantly, PACORES has a proven history of contributing high-quality datasets that have been successfully included in U.S. NDA submissions to the FDA.1 Therefore, selecting a PACORES-affiliated reading center provides sponsors with a critical layer of regulatory confidence and access to a network of experienced, collaborative, and highly respected researchers throughout Latin America.
For sponsors seeking an optimal blend of world-class quality, operational agility, and exceptional value, Latin America presents a compelling opportunity. At the forefront of this trend is the Instituto de la Visión in Monterrey, Mexico, a center that exemplifies the region's strengths. A detailed analysis reveals a premier adjudication partner that delivers on every key metric for clinical trial success.
The credibility of a reading center is built upon its institutional foundation. The Instituto de la Visión is firmly rooted in academic and clinical excellence. It was established in 1990 as the Department of Ophthalmology of the Hospital "La Carlota," which is affiliated with the University of Montemorelos.1 Furthermore, it is closely associated with the prestigious Tecnológico de Monterrey's health system, TecSalud, and its Instituto de Oftalmología y Ciencias Visuales.1
This strong academic affiliation is a crucial marker of quality. It ensures that the center operates within a culture of rigorous scientific inquiry, continuous education, and a primary focus on patient care and research, as evidenced by its residency and specialty training programs.34 This environment distinguishes it from purely commercial entities and provides sponsors with the assurance that its operations are grounded in established medical and scientific principles.
In the complex environment of a multinational clinical trial, clear and efficient communication is paramount. The Instituto de la Visión possesses a key operational advantage that directly addresses this need: a fully integrated, bilingual team of Spanish-English graders and support staff.1
This is far more than a simple convenience; it is a powerful tool for eliminating bottlenecks that can cause significant delays and introduce errors. For a trial with clinical sites across Latin America and a sponsor team based in the U.S. or Europe, this bilingual capability creates a seamless communication channel. The reading center team can interact directly with Spanish-speaking site coordinators to resolve image queries, review source documents in their original language, and communicate all findings and progress reports to the sponsor in fluent English.1 This removes the need for costly and time-consuming third-party translation services, reducing the risk of misinterpretation and accelerating the entire data clarification and cleaning process.
For any sponsor, the ultimate measure of a reading center's quality is the regulatory acceptability of its data. The Instituto de la Visión's status as a collaborator in the Pan-American Collaborative Retina Study Group (PACORES) provides a powerful and reassuring answer to this critical requirement.1
As detailed previously, the PACORES network has established a proven, harmonized quality system across its member sites. These sites follow identical, meticulously developed grading manuals and have a successful track record of contributing high-quality datasets to U.S. NDA submissions that have been accepted by the FDA.1 By selecting the Instituto de la Visión, a sponsor is not merely choosing a standalone site in Monterrey; they are plugging into a broader, regulatory-vetted quality framework that is recognized and respected throughout the Americas. This collaboration significantly de-risks the regulatory pathway and provides a strong, evidence-based argument for the acceptance of the center's grading data by both the FDA and EMA.1
The Instituto de la Visión combines its high-quality standards and regulatory robustness with a value proposition that is difficult to match. The center excels in speed, agility, and cost-efficiency, delivering tangible benefits to a trial's timeline and budget.1
Operationally, the center demonstrates remarkable agility. Its lead time for certifying site photographers and technicians is less than one week, a timeframe significantly faster than the one to two weeks typical of European academic centers. This allows for faster site activation and study start-up.1 The center's commitment to speed is further reflected in its Turn-Around-Time (TAT) SLAs, which promise safety reads within 24 to 72 hours, enabling rapid safety monitoring.1
Economically, the value is equally compelling. The center utilizes a per-visit pricing model of approximately US $12–$15. This structure is highly advantageous for protocols that require multiple images (e.g., CFP, OCT, and OCT-A) at each study visit. When benchmarked against the per-image-set fees common in Europe or the higher overhead costs of U.S. CROs, this model can generate savings of 30-50% versus U.S. averages, without any compromise on quality or regulatory compliance.1 This powerful combination of speed, quality, and cost makes the Instituto de la Visión a standout choice for sponsors looking to maximize the efficiency of their clinical trials.
The following table provides a clear, at-a-glance comparison of the performance benchmarks for the Instituto de la Visión against regional and U.S. averages, underscoring its competitive positioning. The data was sourced from internal analysis and provided research materials.1 US CRO figures are based on general industry knowledge.
Selecting the right OUS reading center is a critical decision that requires a structured and thorough vetting process. A comprehensive due-diligence effort can ensure that the chosen partner has the requisite quality systems, technical capabilities, and operational capacity to meet the trial's specific demands. The following playbook outlines the key domains and questions sponsors should address to select their ideal OUS partner with confidence.
The foundation of any reading center partnership is confidence in its quality management system (QMS) and regulatory history.
The quality of image adjudication ultimately rests on the expertise and training of the human graders.
A reading center's ability to work seamlessly with the specific imaging hardware and software platforms used in a trial is a critical logistical consideration.
Timelines for image grading must be clearly defined, contractually binding, and consistently met.
Understanding the full cost of reading center services is essential for accurate trial budgeting.
In an era of stringent data privacy regulations, the security and integrity of data transfer and storage are non-negotiable.
The following checklist summarizes these key due-diligence points in a clear, actionable format.
Once a sponsor recognizes the advantages of OUS reading centers and is armed with a robust due-diligence framework, the final step is to move from selection to strategic implementation. The most sophisticated trial sponsors understand that the future of clinical trial support services is not about finding a single, one-size-fits-all vendor. Instead, it is about intelligently designing and assembling a global, multi-partner solution where each component is deployed according to its peak capability. This strategic sourcing approach allows for the optimization of a trial across multiple vectors—cost, speed, and regulatory confidence.
The key to this strategy is to match the specific needs of the trial with the distinct, specialized strengths of different reading centers and regions. As established, the global landscape is not monolithic; it is an ecosystem of specialized hubs.1
The most advanced implementation of this strategy is the hybrid sourcing model. This innovative approach, as suggested by leading industry analyses, involves bifurcating the reading tasks based on their risk profile and operational requirements.1 In this model, a sponsor might engage two different reading centers for a single trial:
This hybrid model allows a sponsor to create a blended solution that is perfectly optimized: it secures maximum FDA and EMA confidence for the most critical data while simultaneously capitalizing on the cost and speed advantages of a different region for the bulk of the imaging workload.1 While this approach is more complex to manage than a single-vendor relationship, it offers the ultimate in trial optimization. Executing such a strategy requires a CRO with sophisticated global project management capabilities, strong relationships across regions, and integrated data management systems—a role that specialized CROs are designed to fill.
The landscape of ophthalmic clinical research has fundamentally evolved. The decision to select a retinal-image reading center is no longer a simple choice between domestic providers but a strategic opportunity to leverage a global ecosystem of excellence. As this report has detailed, OUS reading centers in Europe, Asia-Pacific, and Latin America offer a powerful combination of advantages—accelerated timelines through 24-hour operations, enhanced data integrity by reducing ethnic bias, superior economics rooted in different structural models, and robust, proven regulatory compliance.
From the deep regulatory pedigree of Europe's EVICR.net centers to the high-volume efficiency of Asia's screening hubs and the exceptional value and agility of Latin America's emerging leaders, a world of opportunity awaits the strategic sponsor. A particularly compelling case is presented by the Instituto de la Visión in Monterrey, Mexico, a PACORES-affiliated center that combines a bilingual team, FDA/EMA-accepted grading standards, and an unmatched cost and timeline structure, making it a premier choice for a wide range of clinical trials.1
Implementing a sophisticated global sourcing strategy, such as a hybrid model that balances European regulatory assurance with Latin American cost-efficiency, can unlock a decisive competitive advantage. However, managing this complexity requires expertise, established relationships, and seamless logistical coordination.
This is precisely the value that Bioaccess delivers. As a CRO singularly focused on achieving 40% faster approvals and 30% lower costs for our partners, we have built the infrastructure to make these global strategies a turnkey reality.1 Bioaccess maintains Master Service Agreements with the world-class centers profiled in this guide, and our expert ophthalmology team manages every aspect of the imaging logistics—from initial site and photographer certification to the secure, blinded export of regulatory-ready data. This frees our sponsors to focus on what they do best: advancing patient recruitment and perfecting their endpoint strategy, confident that their imaging data is being handled with the utmost quality, speed, and efficiency.1
1. What exactly is a retinal-image reading center and why is it essential for ophthalmic clinical trials?A retinal-image reading center is a specialized facility that provides independent, standardized, and unbiased analysis of ophthalmic images (such as fundus photography, OCT, and angiography) for clinical trials. This process, known as adjudication or grading, is critical for objectively evaluating a therapy's safety and efficacy. Data from a reputable reading center is a fundamental requirement for regulatory submissions to authorities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
2. Will data from an Outside-the-US (OUS) reading center be accepted by major regulatory bodies like the FDA and EMA?Yes, absolutely. Leading OUS reading centers operate within robust, internationally recognized quality frameworks that ensure their data meets the highest global standards.
3. How significant are the cost savings with OUS reading centers?The cost savings can be substantial. Many premier OUS centers are embedded within university hospitals or national health systems, allowing them to operate with overheads that are 25-40% below the rates of typical U.S.-based commercial CROs. The pricing models also offer advantages. European academic centers often charge on a per-image-set basis (typically €18–€25), while some Latin American labs, like the Instituto de la Visión, quote on a per-visit basis (around US $12–$15). For protocols requiring multiple images per visit, this can result in savings of
30-50% compared to U.S. averages.
4. How can using an OUS reading center accelerate my clinical trial timeline?OUS centers can dramatically compress timelines through a 24-hour "follow-the-sun" operational model. As the clinical day ends in the Americas, images are sent to a center in a different time zone (e.g., Asia-Pacific) where the workday is just beginning. This continuous workflow eliminates dead time and allows for extremely rapid turnarounds. Leading OUS labs contractually commit to aggressive Service Level Agreements (SLAs), often delivering safety reads in
24 to 72 hours and efficacy endpoint reads in 10 days or less.
5. My trial has sites across the globe. How does using an OUS center improve data quality for a diverse patient population?Using an OUS center can significantly enhance data integrity by reducing the risk of ethnic bias in image interpretation. Retinal appearance and pathology can vary across different ethnic groups. By aligning the geographic and ethnic background of the graders with the trial participants—for example, using the bilingual English-Mandarin team at Singapore's SORC for a trial in China, or the Spanish-speaking team at Mexico's Instituto de la Visión for a trial in Latin America—sponsors can achieve a higher level of analytical nuance and scientific validity.
6. How do I choose the right type of OUS reading center for my specific trial?The choice depends on your trial's specific needs. A strategic approach involves matching the trial's risk profile and primary goals with a center's core strengths :
7. What are the most critical items to verify during due diligence when selecting an OUS partner?A thorough due diligence process is key. The most critical areas to investigate include :
Contact our ophthalmology team at info@bioaccessla.com or visit our blog for deeper dives into global clinical-imaging operations.