Ophthalmology CRO Services
for Complex Clinical Trials

Talk to a Trial Expert
Background - Sitero Techology
Ophthalmology2026-06-08T19:31:54+00:00
  • 570+ ophthalmology studies supported

  • 67 countries served

  • 32,000 participants across 2,100 sites

Ophthalmology CRO Services for Complex Clinical Trials

Sitero supports sponsors across retinal disease, glaucoma, corneal disorders, ocular inflammation, and rare genetic eye diseases with full-service clinical trial delivery and integrated technology.

Ophthalmology studies demand strong coordination across imaging, visual function endpoints, procedure-based visits, and patient retention. Sitero helps reduce fragmentation across sites, vendors, and study workflows.

Learn More About Sitero’s Ophthalmology Experience

Connect with a Sitero ophthalmology trial expert or submit an RFP.

Mentor Electronic Data Capture for Clinical Trials - Sitero

Built for Ophthalmology Trial Complexity

Ophthalmology trials require precise imaging, consistent endpoints, specialized sites, and thoughtful patient support. Sitero helps sponsors manage that complexity with coordinated services and connected technology.

Common ophthalmology trial challenges include:

  • Diverse patient populations across retinal, corneal, glaucoma, inflammatory, pediatric, and rare inherited eye disorders.
  • Complex eligibility criteria shaped by vision status, prior treatment, laterality, and imaging findings.
  • Endpoint collection across BCVA, ETDRS, intraocular pressure, visual fields, OCT, fundus imaging, and patient-reported outcomes.
  • Imaging workflows that require standardized acquisition, certification, timing, and review.
  • Procedure-heavy visits, patient retention challenges, and close safety monitoring.

Connected Technology for Ophthalmology Trial Execution

Mentor eClinical Technology connects the systems and workflows needed to manage ophthalmology studies with more visibility and less friction.

Clinical Trial Technology that Supports Execution

Sitero’s delivery model is supported by a broad eClinical ecosystem, including:

 

Mentor EDC

Mentor EDC supports ophthalmology protocols with complex visits, eye-specific procedures, laterality tracking, safety forms, and longitudinal endpoints.
Integration advantage

EDC updates can stay aligned with operations and data management as protocols evolve.

Mentor RTSM

Mentor RTSM supports randomization, treatment allocation, supply management, and retreatment workflows for complex ophthalmology studies.
Integration advantage

RTSM and EDC work together to reduce handoff issues across eligibility, treatment, and visit workflows.

Mentor Site and Participant Payments

Mentor Payments supports automated site and participant payments, including travel, caregiver reimbursement, and visit-based fees.
Integration advantage

Connected payment workflows can reduce site burden and improve sponsor visibility into payment status.

Mentor eConsent

Mentor eConsent supports consent workflows for ophthalmology studies, including programs with caregiver involvement, re-consent needs, or long-term follow-up.
Integration advantage

Teams can track consent status in real time and respond faster to version updates or re-consent requirements.

Mentor CTMS and eTMF

Mentor CTMS and eTMF give teams visibility across startup, site activation, monitoring, documentation, and closeout.
Integration advantage

Sponsors can track site readiness, procedural training, and inspection readiness in one connected workflow.

Mentor Insights and Reporting

Mentor Insights and Reporting brings operational, endpoint, imaging, and safety data into one reporting environment.
Integration advantage

Centralized reporting helps teams spot trends earlier and make faster study decisions.

Case Study

PLU Ophthalmic™, a lean medtech sponsor with no in-house clinical or data team, partnered with Sitero to run a complex ophthalmic device study through a single, integrated clinical and technology model combining full-service operations, Mentor EDC/CTMS, and Central IRB support.

  • Unified clinical, technology, and IRB support under one partner
  • Faster study start-up and smoother site activation
  • Streamlined site communication and automated payments
  • Improved data quality and real-time trial visibility

Ophthalmology CRO Services

Sitero supports complex ophthalmology studies across retinal disease, glaucoma, corneal disorders, ocular inflammation, and rare eye conditions with integrated clinical operations, biometrics, safety, ethics, and medical writing support.

Clinical operations

Support for feasibility, startup, site management, monitoring, vendor coordination, and closeout for ophthalmology trials.

Biometrics and Data Management

Our biometrics and data management teams support database design, edit checks, data review, programming, and analysis-ready datasets for imaging-rich studies.

Medical Monitoring and Scientific Oversight

Sitero provides medical oversight for safety review, eligibility questions, protocol interpretation, and clinical issue escalation.

Drug Safety and Pharmacovigilance Support

Support for safety operations for ophthalmic therapies, devices, and advanced modalities that require close monitoring of ocular events.

IRB, Ethics, and Governance Support

Sitero supports ethics workflows, consent updates, amendments, and governance activities across complex ophthalmology studies.

Medical Writing for Ophthalmology Programs

Medical writing team supports protocols, informed consent materials, study reports, regulatory documents, and trial communications.

Sitero Key Metrics

SPEED

40%

DECREASE
in Study Start Up Timelines

COST

54%

DECREASE
in Administrative Costs for the Site

TIME

60%

DECREASE
in Data Management Closeout Timelines

QUALITY

20%

INCREASE
in Protocol Compliance

DATA

100%

GUARANTEE
Transparent Real-Time Reportability

Integrated Workflows for Lower Site Burden and Clearer Oversight

Ophthalmology trials require coordination across operations, imaging, endpoints, safety, and site support. Sitero helps create a more connected model that lowers site burden and improves sponsor visibility.

  • Reduce gaps across operations, biometrics, safety, and technology.
  • Improve visibility into enrollment, imaging status, endpoint review, and follow-up.
  • Support sites with more consistent workflows across visits, procedures, and documentation.
  • Give sponsors a clearer view from startup through closeout.

Global Support for Ophthalmology Programs

Sitero supports global clinical trial services and technology-enabled execution across study models. For ophthalmology programs, our teams help coordinate the operational, regulatory, data, and site details that shape trial performance.

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Why Sponsors Choose Sitero for Ophthalmology Trials

Sponsors typically select Sitero when they need:

Integrated CRO services and technology in one model

Clear ownership across startup, conduct, data, safety, and closeout

Broad functional support for imaging-heavy, operationally complex studies

Global execution without added complexity

FAQs

Can Sitero support long-duration ophthalmology programs with complex retention needs?2026-06-02T15:21:51+00:00

Yes. Sitero helps sponsors manage recurring assessments, follow-up imaging, patient engagement, and retention workflows throughout the study.

Can Sitero support safety operations for ophthalmic therapies and advanced modalities?2026-06-02T15:21:26+00:00

Yes. Sitero supports pharmacovigilance and safety operations for ophthalmology studies, including programs with complex ocular safety monitoring and long-term follow-up.

How does Sitero help manage endpoint quality in ophthalmology studies?2026-06-02T15:20:59+00:00

Sitero supports endpoint quality through database design, data review workflows, monitoring, and biometrics support for repeated visual and imaging-based assessments.

Can Sitero support eConsent and imaging-rich data collection workflows for ophthalmology studies?2026-06-02T15:20:38+00:00

Yes. Mentor eClinical Technology supports eConsent, data capture, and reporting for ophthalmology studies in one connected environment.

What should sponsors look for in an ophthalmology CRO partner?2026-06-02T15:20:21+00:00

Sponsors should look for a partner with experience in imaging quality, endpoint consistency, specialized site workflows, patient burden, and ophthalmic safety monitoring.

Can Sitero support ophthalmology clinical trials across multiple eye disease indications?2026-06-02T15:20:00+00:00

Yes. Sitero supports sponsors across retinal disease, glaucoma, corneal disease, ocular inflammation, and rare inherited eye disorders.

Talk to a Trial Expert

Advance ophthalmology studies with an integrated CRO and technology partner. Sitero supports sponsors across operations, imaging, endpoints, data, safety, and closeout.

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