Ocular Services On Demand (OSOD)

OSOD, LLC, trading as Ocular Services On Demand, is an ophthalmic specialist in Madison, Wisconsin. It describes itself as "a consortium of recognized vision science experts committed to providing world-class services to accelerate identification and development of ophthalmic therapies and devices."^[S1] The word consortium is the key to how it works: OSOD states that its members work through university-based laboratories and lists nine university relationships.^[S9] It was acquired on January 22, 2025 by MERIT, described in the announcement as "a global clinical trial endpoint and technology services provider."^[S2] That MERIT is a private clinical trial services business in Madison and is identified in the acquisition announcement as the Madison-based clinical trial services company; neither website addresses the distinction, so it is noted here to prevent confusion.

Services relevant to US drug and device developers

Study design, program strategy, and monitoring

The preclinical discovery service is framed around access and advice rather than bench execution: the company offers to "provide access to the relevant and translatable efficacy models"^[S5] and gives "guidance on formulation"^[S5] alongside non-GLP ocular safety and tolerability work and pharmacokinetic and ocular distribution studies.^[S5] The non-clinical development service covers "GLP toxicology program design and execution,"^[S6] IND-enabling safety and toxicology study design and monitoring of in-life IND-enabling studies across ophthalmic routes of administration and species.^[S6] An IND is not "approved" by FDA: under 21 CFR 312.40 it goes into effect 30 days after FDA receives it unless FDA imposes a clinical hold.^[R1] A CRO may conduct and report nonclinical studies that a sponsor includes in an IND, but it cannot guarantee that FDA will allow the clinical investigation to proceed. Because the in-life work happens at partner sites, sponsors should establish at the outset which organization is the study facility, who the study director is, and where the GLP obligations sit.

Ocular pathology and electrophysiology

Two technical services are performed as named OSOD capabilities. Ocular pathology covers bright field light microscopy, immunohistochemistry, transmission and scanning electron microscopy and atomic force microscopy, drawing on "a reference slide library that contains over 23,000 pathology specimens dating back to 1921."^[S7] Electrophysiology covers full-field, multifocal and pattern electroretinography and visual evoked potentials, with the company stating that "all testing adheres to the recommended guidelines set forth by the International Society for Clinical Electrophysiology of Vision (ISCEV)."^[S8] Sponsors can ask OSOD to specify which pathology and electrophysiology endpoints it will perform itself and which will be performed at a partner laboratory.

Where the animals actually are

The company states that "behind each of our OSOD members is a fully-functioning research laboratory supported by university-based resources,"^[S9] naming nine partner universities: the University of Wisconsin-Madison, the University of California Davis, Texas Tech University, the University of Houston, Cornell University, the Ohio State University, Indiana University, the Medical University of South Carolina and McMaster University.^[S9] For each in-life study, sponsors should identify the study facility, the institution responsible for animal care and use oversight, and the contracting parties. For a sponsor this has two consequences. First, oversight responsibility follows the institution that houses the animals. Second, contracts, data ownership and GLP responsibilities need to be mapped across more than one organization before a study starts.

Quality, compliance, and animal welfare (as stated by the company)

GLP. The company offers "GLP toxicology program design and execution"^[S6] and study monitoring. The company's website does not name a specific GLP regulation (FDA 21 CFR Part 58, EPA 40 CFR Part 160/792, or OECD GLP) for its facilities.^[S6] GLP compliance is determined study by study under the applicable regulation, so sponsors should confirm in the protocol which regulation their study will follow and that the final report will carry the study director's compliance statement and the quality assurance unit's statement.^[R2] Given the partner model, the GLP compliance statement that ultimately matters is the one issued by the facility that runs the study. No AAALAC accreditation, USDA registration, OLAW Animal Welfare Assurance or IACUC statement appears on OSOD's own pages, that is an absence in those pages, not a finding about the status of OSOD or of any partner institution; the corresponding statements should be obtained from each partner site. AAALAC International accreditation is a voluntary evaluation of an institution's animal care and use program, re-evaluated every three years,^[R3] and USDA registration and an OLAW Animal Welfare Assurance relate to the Animal Welfare Act and the PHS Policy respectively;^[R4][R5] none of these establishes GLP compliance, which applies to individual studies.^[R2] FDA does not approve or certify laboratories; registration with FDA does not denote approval.^[R6]

Company facts