High Touch. High Science.
Highly Flexible.

Full-service ophthalmic CRO solutions, tailored to your trial, your timeline, and your therapeutic area.

End-to-End Ophthalmic Clinical Trial Support

iuvo provides a complete range of clinical trial services tailored specifically for ophthalmology. From early development through regulatory submission, our experienced team manages every aspect of your trial with precision and care. Our clinical research services are fully integrated to support your program from concept to commercialization.

We understand the unique challenges of eye research – whether testing a new dry eye therapy or a retinal gene therapy – and we have the specialized processes to address them. Our goal is to streamline your path to approval while maintaining the highest standards of quality and compliance.

Big CRO Capability.
High-Touch Attention.

Built for complexity. Driven by partnership.

Our Full-Service CRO Capabilities

No matter the phase or complexity of your trial, iuvo has you covered.

Designing studies with precision from the start.

Study Design & Protocol Development

We work with you to design robust study protocols and endpoints that align with
both scientific objectives and regulatory expectations. Our experts (including
board-certified ophthalmologists) ensure your trial is set up for meaningful results
and approval success.

Navigate the regulatory maze with clarity and confidence.

Regulatory Strategy & Submissions

Navigate the regulatory maze with our guidance. We assist with IND/IDE filings, IRB submissions, and global regulatory approvals, leveraging our knowledge of FDA and international guidelines specific to ophthalmology. From pre-IND meetings to NDAs/PMAs, we help position your program for regulatory success.

One team, one point of contact, total accountability.

Project Management

Your dedicated project manager will oversee all trial activities from start to finish, keeping timelines on track and budgets in check. We use proven project Page 5 of 27 management processes to coordinate teams, vendors, and sites, providing you with regular updates and one-touch accountability for all trial aspects.

Access the right sites and the right investigators, faster.

Site Identification & Monitoring

Benefit from our extensive ophthalmic site network and relationships with key investigators. We identify and qualify high-performing clinical sites and KOLs for your study. Our clinical research associates then conduct on-site and remote monitoring visits to ensure protocol adherence, data integrity, and GCP compliance throughout the trial. We also organize investigator meetings and training to align study teams from day one.

Tailored strategies to find and keep the right patients.

Patient Recruitment & Retention

We develop targeted recruitment strategies to find the right patients – even for challenging populations or rare diseases. Our team works closely with sites on community outreach, referrals, and education. Throughout the study, we implement patient-centric retention initiatives (visit reminders, travel support, etc.) to minimize dropouts and keep participants engaged.

Scalable systems, real-time access, and 21 CFR Part 11 compliance.

eClinical Technologies & Data Management

We support fast, flexible study execution with scalable, web-based systems — tailored to your trial’s needs and built with full 21 CFR Part 11 compliance.

EDC & Clinical Portals – Web-based systems for rapid setup, real-time access, and secure file sharing across sites and sponsors
Custom Clinical Programming – Built for complex ophthalmic studies and aligned with your endpoints and timelines
24/7 Access – Role-based user access ensures timely data visibility across teams
Document Collaboration – Study-specific portals for secure uploads, live metrics, reports, and communications
CTMS – Platform technology ensures efficient delivery of the trial, tracking of key trial metrics, and seamless communication
eTMF – Veeva® eTMF platform allows for compilation of critical documents from beginning of the trial, facilitating efficient transfer at trial
end
Site Feasibility – Cutting edge AI technology reduces risk of enrollment challenges by screening and selecting sites with high productive probability

Insightful analytics from first plan to final report.

Biostatistics & Programming Support

From study design to post-study analytics, our experienced biostatisticians and programmers deliver strategic guidance and statistical rigor — ensuring meaningful, inspection-ready results.

Before the Study
- Sample size and power analysis
- Endpoint modeling and SAP development
- CRF review and randomization schedule creation
During the Study
- Real-time data QC and interim analysis
- Ongoing collaboration with Data Management
- TLF shells for standard and custom reporting
After the Study
- Final tables, listings, and figures (TLFs)
- Statistical result interpretation
- Ad-hoc or publication-ready analysis
- Independent QC of all datasets and outputs

Clinical oversight by ophthalmic experts.

Medical Monitoring & Safety Reporting

Patient safety is paramount. Our medical monitors (ophthalmologists) provide ongoing oversight of subject well-being and eligibility. We closely track adverse events and perform pharmacovigilance reporting in compliance with regulatory requirements. In partnership with investigators, we ensure any safety signals are identified and addressed promptly.

Clear, compliant documentation that tells your story.

Medical Writing & Clinical Reports

Count on our skilled medical writers to prepare high-quality documentation for your study. We draft everything from investigator brochures, study protocols, and informed consent forms to Clinical Study Reports (CSR) and clinical submission documents for regulatory filings. Our writing team distills complex trial data into clear, accurate, and compelling narratives that support your product’s story.

Built-in quality at every step.

Quality Assurance & Compliance

iuvo maintains a rigorous Quality Management System to deliver audit-ready results. We offer GCP auditing and compliance services – whether auditing sites, vendors, or trial master files – to ensure that your study can withstand scrutiny. We are ISO 9001:2015 certified and have been continuously accredited for 20 years.

Seamless behind-the-scenes coordination.

Clinical Logistics & Support

We coordinate the behind-the-scenes details that keep your trial running smoothly. This includes management of investigational product supply (packaging, labeling, and distribution logistics, with interactive randomization technologies), lab sample handling and central lab coordination, and meeting planning for investigator or advisory board meetings. Every operational detail is handled so you can focus on the big picture.