Global Ophthalmic Research with Strategic Site Insight
UK Hospitals
Hospital Staff Relationships
Years of Experience
While our operational footprint is worldwide, our depth of knowledge in the UK and Western European clinical landscape is a primary asset for our partners. We operate as a specialist, global CRO, managing everything from niche pilot studies to multi-national programmes. Our expertise in vision science allows us to move beyond generic trial management, focusing instead on the unique technical and patient-centric hurdles that define modern ophthalmology.
Navigating the Nuances of Vision Science
Ophthalmic research is increasingly defined by high-precision interventions, including subretinal surgeries, gene therapy deliveries, and sustained-release implants. These protocols demand more than just standard monitoring. We build trial-specific operational and monitoring plans for ophthalmology studies, paying particular attention to ocular safety, BCVA assessment and OCT data quality
Beyond the Prestige: Real-World Site Performance
A common pitfall for sponsors is assuming that the most prestigious eye hospitals are the optimal choice for every study. Through our deep-rooted experience with UK and Western European sites, we know that high-prestige institutions are not always the quickest to navigate through the set-up phase or the most efficient at meeting recruitment targets.
Our advantage comes from years of direct, on-the-ground collaboration. We know which sites have the capacity to fast-track contract negotiations and which units have "ready-to-go" patient registries versus those that are over-saturated with competing trials. By working with us, you gain access to this local intelligence, ensuring your protocol is placed where it will actually move, not just where it looks good on a slide deck.
Project Coordination
We act as the vital link between the sponsor, the clinical site, and the reading centre, ensuring that equipment is calibrated correctly and that data is captured with the surgical precision required for advanced ocular therapies.
Frequently Asked Questions
What defines your approach to global ophthalmology trials?
We combine a boutique, agile management style with a global reach. Whether we are managing a site in London or Lyon, our focus remains on high-quality data and senior-level oversight. We don’t just monitor; we troubleshoot the specific challenges inherent in vision research.
How do you help sponsors select the right European sites?
Because we know the UK and European sites so intimately, we guide sponsors toward locations that offer the best balance of clinical expertise and operational speed. We help you avoid the "prestige trap" by identifying sites that have the capacity to recruit and the infrastructure to handle complex imaging requirements.
Can you handle the regulatory hurdles for gene therapies in the eye?
Yes. Our team is well-versed in the specific regulatory frameworks for Advanced Therapy Medicinal Products (ATMPs). We can manage the complex submissions required for novel ocular therapies, ensuring that all safety protocols and surgical follow-ups meet stringent international standards.
How do you ensure data quality across different imaging platforms?
We standardise imaging protocols at the outset. By working closely with site technicians and independent reading centres, we can ensure that every OCT or fundus photograph is captured consistently, regardless of the geographical location of the clinic.
What makes your project teams different from a large CRO?
Continuity. You won’t deal with a revolving door of junior staff. In ophthalmology, where understanding a protocol's nuances is critical, having the same senior experts from planning through to close-out prevents data errors and delays.
Do you support medtech and medical device companies in this field?
From early prototype evaluations to post-market clinical follow-up, we provide the regulatory and clinical framework necessary to bring new vision technologies to market.
Case Study: Managing a First-in-Eye Trial for Atopic Keratoconjunctivitis (AKC)
We managed pivotal first-in-eye Phase I/II trial evaluating a topical agent for patients with moderate to severe, recalcitrant AKC. This study required the careful integration of a novel dual-action inhibitor (C5 and LTB4) into a patient group that had previously failed maximal standard therapies.
Our team coordinated the complex data collection required to track both clinical signs and patient-reported symptoms. By leveraging our close relationships with specialist ocular surface units, we successfully navigated the challenges of recruiting a rare patient population.
Tailored Clinical Research Solutions (TCRS) collaborated with us on one of our early-phase, multi-centre ophthalmology trials, and the experience was excellent from start to finish.
I was particularly impressed by the consistently high standard of service and the team’s deep expertise, especially their nuanced understanding of NHS hospital systems, which proved invaluable throughout the study.
TCRS offered a flexible approach and adapted to the needs of our fast-moving biotech environment. The project manager was highly knowledgeable, proactive in identifying and managing risks, and kept us well informed at every stage. We also appreciated the ability to easily access the leadership team whenever needed, which added an extra level of responsiveness and confidence.
Overall, their depth of experience, adaptability, and genuinely tailored approach made for a successful and collaborative partnership.