Biostatistics and programming services informed by experience across ophthalmic indications and current regulatory guidance.
We provide input on acceptable endpoints, study design, and statistical planning, along with programming support to prepare datasets for analysis and regulatory submission. Statistical outputs and interpretations are communicated clearly, helping stakeholders understand study data and make informed decisions throughout the trial.
Clinical database build and management designed to support accurate, compliant data capture from the start of a study.
Services include CRF design aligned with customized EDC databases, along with appropriate coding, reports, and dashboards that deliver essential study data in a timely manner. Database services support trials of any size using validated, Part 11–compliant EDC platforms, with data integrity and GCDMP compliance maintained throughout the data lifecycle.
Medical writing and regulatory support informed by experience in ophthalmic development programs.
Regulatory strategy is considered early to help guide development pathways and support efficient program progression. Services include clinical trial design, documentation, and submission to regulatory authorities.
Clinical monitoring designed to support accurate documentation and protocol compliance at the site level.
Monitoring plans are tailored to the needs of each study and structured to foster productive, solution-oriented relationships between sponsors and research sites.
Project management focused on the coordination and oversight required to keep studies progressing efficiently.
This includes tracking timelines, coordinating deliverables, and addressing issues as they arise to keep programs aligned with study goals and regulatory expectations.
Safety management for ophthalmic clinical research supported by collaboration with a network of experienced ophthalmologists across indications.
Study-specific safety plans are developed and implemented, with ongoing medical oversight to support patient safety throughout the course of a trial.
Site development services designed to help practices of any size establish and grow successful clinical research programs.
We help simplify the transition into research, build a strong operational foundation, and maintain compliance as sites develop long-term research capability.
Our team also works with an experienced network of ophthalmology research sites across the United States and collaborates with European partners to identify the most appropriate sites for each study. Site selection is supported by data-driven tools that help identify sites with the greatest potential for timely enrollment.