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In pharmaceutical and biotech preclinical research, veterinary care and study data are closely linked. Under the Food and Drug Administration (FDA) Good Laboratory Practice (GLP) regulations, an animal assigned to a study may be treated only if the treatment does not interfere with the study. The diagnosis, authorization, description, and dates of treatment must be documented, and circumstances that may affect data quality must be described in the final study report.
Veterinary staff, study directors, and quality assurance therefore rely on the same health information. This article explains what animal health monitoring needs to cover in regulated preclinical programs, where gaps can appear across sites and contract research organizations (CROs), and how to evaluate preclinical animal health software.
What Animal Health Monitoring Covers in Preclinical Research
Animal health monitoring follows each animal from arrival to final disposition. It includes health evaluation during quarantine and acclimation, daily observations, clinical cases and treatments, surgical and post-procedure care, welfare assessments, colony surveillance, and humane endpoints.
Under 21 CFR Part 58, newly received animals must be isolated and their health status evaluated, and animals must be free of any condition that could interfere with the study. The study director must note unforeseen circumstances that may affect study quality or integrity, and a veterinary decision made in the animal room can be one of them.
The frameworks that apply to a preclinical program depend on the species, the type of study, and the source of funding. The table below summarizes the main ones.
One facility may house GLP studies, non-GLP discovery work, quarantine animals, and breeding colonies, all served by one veterinary program. Our overview of USDA and OLAW requirements covers the welfare frameworks in more depth.
Where Animal Health Information Breaks Down in Pharma and Biotech Programs
When animal health information is divided among veterinary notes, study systems, facility software, and spreadsheets, gaps can appear at the handoffs between them.
- Treatment decisions recorded apart from the study: When a clinical sign is logged in a study system but the diagnosis and treatment are kept in separate veterinary notes, the study director may learn of a treatment late. Quality assurance then reviews documentation that had to be compiled manually.
- Animals outside active studies: Quarantine, holding, and colony animals can fall outside study-based tools, which makes facility-wide health trends harder for the veterinary team to see.
- Different practices across sites: When each site documents clinical care its own way, program-level oversight takes more effort.
- Outsourced studies: When a study runs at a CRO, the sponsor’s view of animal health depends on what the CRO reports and when.
- Inspection and accreditation preparation: Institutional Animal Care and Use Committee (IACUC) semiannual program reviews, AAALAC site visits, and FDA GLP inspections all examine animal care documentation. When this documentation is maintained in separate systems, a missing treatment date may not be identified until the review is underway.
Software can reduce the manual work at each of these handoffs. Veterinarians remain responsible for clinical decisions, and the study director remains accountable for the conduct of the study.
Study Data Systems and Animal Health Systems Serve Different Purposes
Study data capture systems are organized around the study protocol. They record in-life data such as body weights, clinical observations, and dosing as study raw data. For an organization whose core work is GLP toxicology, such as a CRO focused on regulatory safety studies, a dedicated study data system is the appropriate primary tool.
Animal health systems are organized around the veterinary program. They manage clinical cases, treatments, medication, surgery, welfare assessments, and euthanasia for every animal in the facility, whether or not it is assigned to a study.
A preclinical organization may need both. The practical question is how veterinary decisions reach the study team and how study context reaches the veterinarian. Our vivarium software comparison covers other facility system categories.
What to Look for in Animal Health Monitoring Software for Pharma and Biotech
When evaluating animal health monitoring software, pharma and biotech teams should weigh the capabilities that affect study continuity, animal welfare, and inspection readiness.
- Coverage of every animal: Health records should cover every animal, whether or not it is assigned to a study, including quarantine and colony animals, so veterinarians work from complete histories.
- Structured veterinary documentation: Clinical notes should follow a structured format such as SOAP (Subjective, Objective, Assessment, Plan), and treatment entries should capture the diagnosis, authorization, description, and dates that GLP requires.
- Prompt escalation from the animal room: Staff should be able to report a concern where they work, with routing to the right veterinarian and response times tracked.
- Visibility for the study team: The study director should learn promptly when an animal assigned to a study is treated, so the event can be assessed and documented.
- Integration with protocol oversight and facility operations: Health information should be tied to the approved IACUC protocol and the animal’s housing location without manual re-entry.
- Data integrity controls: Audit trails and role-based access are baseline expectations. Where electronic records support FDA submissions, scientific systems teams should also assess the system against 21 CFR Part 11, which sets criteria for electronic records and signatures.
- Multi-site configuration and interoperability: Workflows should be consistent across sites, and the system should exchange data with electronic lab notebooks (ELN), laboratory information management systems (LIMS), and study data systems.
Test these criteria with a scripted scenario built on your own procedures, such as an animal in a GLP study that develops a clinical sign and needs treatment.
How Key Solutions Supports Preclinical Animal Health Monitoring
Key Solutions’ Lab Animal Resource Software (LAHS) is designed around the veterinary program. It works within the Key Solutions animal research suite alongside eProtocol Animal Subjects (IACUC), Lab Animal Resource Software (LARS), and IACUC-PAM (Post-Approval Monitoring), which share a common data model. Four capabilities are most relevant to pharma and biotech programs.
- Veterinary care for every animal in the facility: LAHS maintains animal health records with a unique ID for each animal and covers both planned and unplanned events. It supports SOAP documentation, treatment planning with reminders, medication and surgical management, welfare assessment, colony health surveillance, and euthanasia records.
- Timely response to health concerns: Staff can report incidents from mobile devices, and LAHS notifies the appropriate veterinary staff and tracks response times. Related incidents can be linked so care teams can see patterns.
- Animal care tied to protocol approvals: LAHS links animal health records to approved IACUC protocols. When an animal is placed under treatment, the flag is visible across the suite, and the animal cannot be used in a procedure until a veterinarian clears it.
- Designed to work alongside existing systems: LAHS can integrate with ELN and LIMS, and standardized SOAP workflows support consistent documentation across sites. Key Solutions also provides data migration and third-party integration services. Organizations with an established study data system can evaluate LAHS as the veterinary layer alongside it.
Key Solutions brings 15+ years of focus on life sciences research, is ISO 27001:2022 certified, and builds for complex research environments. Learn how Key Solutions supports pharma and biotech organizations.
Humane care and reliable study data depend on the same veterinary information. Software that makes that information visible to study teams supports both. To see how LAHS can support your veterinary program, schedule a demo.
