Ophthalmology CRO

Leveraging decades of expertise in ophthalmology clinical research, our dedicated specialists navigate the complexities of ocular drug and device development with precision, innovation, and a patient-centered approach to ensure the success of your trial.

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Ophthalmology CRO

Strategic Ophthalmology CRO Solutions for Advancing Ophthalmic Drug Development

TFS specializes in ophthalmology clinical trials, providing comprehensive support to navigate regulatory complexities, imaging requirements, and patient recruitment challenges unique to this field. Our cross-functional teams, spanning retinal diseases, corneal disorders, glaucoma, ocular inflammation, and ophthalmic rare diseases, bring extensive therapeutic expertise with global regulatory knowledge to accelerate the development of vision-saving treatments worldwide.

With a proven track record in ophthalmology drug and device development, we empower sponsors to streamline trial operations, enhance patient engagement, and ensure regulatory compliance across different regions. Whether conducting gene therapy trials for inherited retinal diseases, targeted therapies for glaucoma, or ophthalmic device studies, our full-service ophthalmology CRO solutions ensure efficient execution at every stage.

Ready to shape the future of ophthalmology clinical research? Connect with our ophthalmology clinical trial experts.

Comprehensive Phase I to IV Ophthalmology CRO Services
Built on Experience and Precision

With nearly 30 years of experience and over 70 ophthalmology clinical trials completed, TFS is a trusted partner in ophthalmology drug and device development. Our team ensures that every study is conducted with scientific integrity, operational efficiency, and a patient-first approach.

Global Reach

600
+
trial sites across 30+ countries

Broad Experience

20
+
ophthalmology indications

Proven Expertise

70
+
completed clinical trials across phase I-IV and RWE studies

Patient Impact

5,000
+
patients enrolled in ophthalmology clinical trials
ophthalmology CRO

TFS’s ophthalmology CRO expertise extends into rare ophthalmic diseases, advancing orphan drug development and innovative therapies for inherited retinal disorders and other rare ocular conditions.

Decades of Ophthalmology Clinical Research Experience and Proven Success

As a leading ophthalmology contract research organization (CRO), TFS brings decades of experience in drug and device development, ensuring seamless execution across all trial phases. Our ophthalmology teams are highly specialized in managing complex imaging protocols, endpoint validation, and rare ophthalmic disorder studies. We ensure high-quality results through scientific precision, regulatory expertise, and innovative methodologies. Our track record of success in ophthalmology research reflects our commitment to advancing sight-saving therapies and improving patient outcomes worldwide.

See how we overcome obstacles to deliver results in ophthalmology research. Read our case study.

Navigating Complexity: TFS’s Tailored Solutions for a Global Phase III Neovascular AMD StudyCase Study

Navigating Complexity: TFS’s Tailored Solutions for a Global Phase III Neovascular AMD Study

Leading Ophthalmology CRO Driving Ophthalmic Innovation

TFS is a trusted partner in ophthalmology clinical development, offering scientific expertise, global trial capabilities, and operational excellence to advance drug and device innovation. Our dedicated ophthalmology team supports sponsors in designing and executing complex clinical trials, leveraging adaptive trial frameworks, imaging biomarkers, and patient-centered strategies to enhance study precision and efficiency. With deep expertise in biologics, gene therapy, ophthalmic devices, and regenerative medicine, TFS ensures seamless navigation of regulatory pathways and global trial execution, accelerating the development of sight-saving therapies.

Explore the latest challenges and considerations in gene therapy for inherited retinal diseases (IRDs). Read our white paper.

Challenges and Considerations for Inherited Retinal Diseases (IRDs) Trials
Challenges and Considerations for Gene Therapy Trials for Inherited Retinal Diseases (IRDs)White paper

Challenges and Considerations for Gene Therapy Trials for Inherited Retinal Diseases (IRDs)

Ophthalmology Clinical Studies

Broad Indication Expertise in Ophthalmology Clinical Studies

TFS provides end-to-end support for ophthalmology clinical trials, ensuring accelerated enrollment and operational efficiency through our global site network and trusted investigator partnerships. Our expertise spans complex ophthalmic indications, demonstrating our commitment to advancing transformative therapies:

Retina & Posterior Segment Diseases

Age-Related Macular Degeneration (AMD) (Wet and Dry), Diabetic Retinopathy, Diabetic Macular Edema (DME) (a complication of Diabetic Retinopathy), Inherited Retinal Diseases (IRD), including Stargardt’s Disease and Retinitis Pigmentosa, and Geographic Atrophy (GA)

Corneal & Anterior Segment Diseases

Dry Eye Disease (DED), Blepharoconjunctivitis, Keratoconjunctivitis, Corneal Cross-Linking for Keratoconus, and other corneal disorders

Glaucoma & Ocular Hypertension

Primary Open-Angle Glaucoma, Ocular Hypertension, and Minimally Invasive Glaucoma Surgery (MIGS) devices, including MicroShunts, Cypass, Xen, and Tube Shunts

Ophthalmic Devices & Surgical Innovations

Intraocular Lenses (IOLs), Artificial Iris, Drug-Eluting Ophthalmic Devices, Lens Devices for Glaucoma, Corneal and Retinal Applications, and Surgical and Anesthesia Devices for Ophthalmology

Ocular Inflammatory & Rare Ophthalmic Disorders

Uveitis, Uveal Melanoma, and Optic Neuropathy

clinical trial icon

With our comprehensive capabilities and dedication to precision, TFS is the partner of choice for biotechnology sponsors seeking reliable support in ophthalmology clinical development.

Meet Our Dedicated Ophthalmology Team

Our ophthalmology leadership team brings decades of experience in ocular drug and device development, providing strategic oversight and hands-on expertise to navigate the complexities of ophthalmology clinical trials. With deep knowledge of specialized imaging, regulatory challenges, and patient recruitment, our experts ensure seamless execution across all phases of development. From retinal diseases and glaucoma therapies to anterior segment disorders and ophthalmic surgical innovations, we combine therapeutic expertise with operational excellence to drive efficient trial execution, precise endpoint assessments, and regulatory success.

Marcia Swank

Marcia Swank

VP, Head of Ophthalmology

Chris Kelley

Senior Director, Project Delivery, Ophthalmology

Bhakti Patel

Bhakti Patel

Senior Director, Project Delivery, Ophthalmology

Jessica Wessel

Jessica Wessel

Senior Director, Project Delivery, Ophthalmology

Ophthalmology Insights

Geographic Atrophy Clinical Trials
The Case for a New Paradigm in Geographic Atrophy Clinical Trials: Leveraging Genetics, Smarter Endpoints, and AIWhite paper

The Case for a New Paradigm in Geographic Atrophy Clinical Trials: Leveraging Genetics, Smarter Endpoints, and AI

Discover how genetics, advanced imaging, and artificial intelligence are transforming geographic atrophy clinical trials.
Driving-Efficiency-TFS-Accelerates-Time-Sensitive-Ophthalmology-Trial-with-Full-Service-Delivery_featured
Driving Efficiency: TFS Accelerates Time-Sensitive Ophthalmology Trial with Full-Service DeliveryCase Study

Driving Efficiency: TFS Accelerates Time-Sensitive Ophthalmology Trial with Full-Service Delivery

Explore how TFS met aggressive enrollment and timelines in a Phase III dry eye disease trial by leveraging full-service execution, site intelligence, and deep therapeutic expertise.
TFS-Drives-Global-Start-up-for-Multinational-Geographic-Atrophy-Trial_featured
TFS Drives Global Start-Up for Multinational Geographic Atrophy TrialCase Study

TFS Drives Global Start-Up for Multinational Geographic Atrophy Trial

Discover how TFS successfully launched a multinational Phase IIb geographic atrophy study in ophthalmology.

Comprehensive Ophthalmology CRO to Advance Vision Research

TFS specializes in ophthalmology clinical trials, supporting sponsors in the development of novel therapies for retinal, anterior segment, and rare eye diseases. With expertise in biologics, gene therapy, medical devices, and regenerative medicine, we provide tailored solutions that address the complexities of ophthalmic drug and device development.

Global Expertise in Ophthalmology Clinical Trials

As a leading ophthalmology CRO, TFS ensures seamless execution of global ophthalmic trials through:

  • A worldwide network of ophthalmology research sites and investigators, supporting efficient study start-up and patient enrollment.
  • Expertise in multi-country regulatory submissions, ensuring FDA, EMA, and internal compliance.
  • Tailored patient recruitment strategies, accommodating visual impairments needs and caregiver considerations.
Advancing Ophthalmology with Biologic Therapies

Advancing Ophthalmology with Biologic Therapies

TFS has experience managing clinical trials for biologic treatments targeting retinal diseases, inflammatory conditions, and anterior segment disorders with expertise including:

Ophthalmic Gene Therapy Expertise

Ophthalmic Gene Therapy Expertise

Gene therapy is transforming inherited and acquired retinal diseases, and TFS provides specialized expertise in:

  • AAV vector-based gene therapies, ensuring compliance with surgical administration, long-term monitoring, and ophthalmic imaging
  • Gene-editing strategies for rare retinal dystrophies and progressive vision loss disorders
  • Regulatory and operational support for navigating the complexities of ophthalmic gene therapy trials, from IND/CTA submissions to post-market studies
Specialized Clinical Development for Ophthalmic Devices

Specialized Clinical Development for Ophthalmic Devices

With ophthalmology is one of the most device-driven therapeutic areas, TFS offers expertise in:

  • Ophthalmic implants and surgical tools, including glaucoma drainage devices, corneal inlays, and sustained release drug delivery systems
  • Medical device trials aligned with global regulatory standards, ensuring compliance with FDA, EMA, and ISO requirements
  • Innovative trial designs for ophthalmic devices, incorporating real-world performance measures, long safety, and patient usability studies
Advancing Regenerative Medicine for Vision Restoration

Advancing Regenerative Medicine for Vision Restoration

The potential for stem cell therapies and tissue-engineered treatments in ophthalmology is expanding and TFS supports research in:

  • Retinal pigment epithelial (RPE) transplants and stem cell therapies for geographic atrophy in dry AMD
  • Corneal regeneration treatments, including bioengineered tissue implants for corneal damage and dystrophies
  • Advanced methodologies for long-term follow-up and efficacy evaluation in regenerative ophthalmology trials

Frequently Asked Questions About Our Ophthalmology Clinical Trials

What makes TFS brings decades of experience in ophthalmology clinical research, supporting sponsors with specialized trial methodologies, advanced imaging capabilities, and global investigator networks. Our experts ensure seamless execution across all phases of drug and device development, delivering high-quality results efficiently.

Can TFS support complex imaging and endpoint assessments in ophthalmology trials?

TFS collaborates with leading reading centers and imaging specialists, providing high-resolution OCT, fluorescein angiography, fundus photography, and other advanced imaging solutions for ophthalmology studies.

How does TFS optimize patient recruitment for ophthalmology trials?

We leverage AI-driven patient targeting, digital recruitment strategies, and an established ophthalmology site network to enhance trial enrollment and retention. Our extensive investigator relationships ensure access to diverse and specialized patient populations.

Does TFS have expertise in ophthalmic gene therapy research?

Our team has experience in ophthalmology gene therapy trials, supporting subretinal and intravitreal delivery techniques, patient recruitment, and regulatory compliance. We partner with sponsors to navigate the complexities of gene therapy in inherited retinal diseases and other vision-related conditions.

How does TFS ensure data quality in ophthalmology clinical trials?

We employ real-time data monitoring, centralized data management, and ophthalmic imaging validation to maintain high data integrity and trial success. Our regulatory and safety teams work closely with sponsors to ensure compliance with evolving standards.

Where can you find the TFS Ophthalmology Clinical Development team?

TFS regularly attends and presents at leading global ophthalmology conferences and events. You can connect with our team at upcoming meetings such as Euretina Congress, AAO, and ARVO.

These forums are excellent opportunities to meet our ophthalmology experts, explore partnership opportunities, and learn more about our commitment to advancing ophthalmology research worldwide.

Partner with TFS HealthScience

Ready to advance ophthalmology research? Contact TFS today to explore how we can support your ophthalmology clinical trial needs with precision, expertise, and patient-centered solutions.

Contact us to start your journey