In-Life Study Sponsors
Sponsors running pharmacology, toxicology, or immunology studies at Alpha Genesis rely on integrated laboratory support to complete their data package without managing multiple external vendors.
Research animal retirement and lifetime care, now available through Alpha Genesis. Professionally managed lifetime care for retired research primates, with expert social reintroduction into stable outdoor groups led by veterinary staff deeply experienced in laboratory-animal medicine.
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Clinical pathology, in-house sample processing, bioanalysis coordination, structured data capture, and biospecimen logistics that connect in-life study execution to the analytical and reporting outputs your program requires.
In-life study conduct and laboratory data generation are inseparable components of a well-executed preclinical program. The interpretive value of toxicology, pharmacology, or immunology data depends on clinical pathology results that are collected at the right timepoints, processed under validated conditions, and reported with the clinical context that veterinary review provides. Alpha Genesis laboratory support capabilities are integrated directly into our in-life programs, not bolted on.
Our in-house capabilities include clinical pathology sample collection and processing, sample preparation and aliquoting for downstream analytical workflows, data capture and summary reporting, and biospecimen logistics coordination. For specialized analytical assays, including bioanalytical PK assays, flow cytometry, multiplex cytokine analysis, and histopathology, we coordinate with qualified partner laboratories and manage sample logistics, chain-of-custody, and data integration.
Data integrity is an organizational value, not a project-specific quality gate. Every data point generated in support of a study, from body weights to sample labels to clinical observation timestamps, is captured in structured formats, reviewed for accuracy, and maintained in audit-ready documentation. This discipline applies equally to non-GLP exploratory work and GLP-aligned regulatory programs. It is also what lets us consistently generate high-quality regulatory data, structured to support the submissions sponsors make to major health authorities in North America and internationally alike.
Sponsors running pharmacology, toxicology, or immunology studies at Alpha Genesis rely on integrated laboratory support to complete their data package without managing multiple external vendors.
Toxicology sponsors with repeat-dose designs requiring hematology, serum chemistry, and urinalysis at multiple timepoints use our in-house clinical pathology infrastructure for same-study integration.
Programs that require PK bioanalysis, multiplex immunoassays, or flow cytometry through external labs use our sample management and shipment coordination to protect sample integrity and chain-of-custody.
IND-enabling and global development programs requiring traceable laboratory data capture, structured reporting, and audit-ready documentation find our GLP-aligned data management infrastructure essential.
Laboratory support services are provided across all study species supported at Alpha Genesis.
NHP-specific reference ranges, species-validated processing protocols, and veterinary clinical pathology interpretation are available for macaque study programs.
Rat clinical pathology is supported with historical control reference data from in-house study populations for contextual interpretation of findings.
Mouse sample processing and clinical pathology support is available where sample volume and study design permit standard panel collection.
Laboratory support, including species-appropriate processing and clinical pathology interpretation, is available for African green monkey study programs.
Laboratory support is available for capuchin monkey programs where a New World primate model is scientifically appropriate.
Laboratory support extends to additional species, including spider monkeys, pigtail macaques, baboons, and marmosets, available on request for custom programs.
Clinical and diagnostic pathology is anchored by veterinary interpretation of hematology, serum chemistry, and urinalysis results, integrated with study endpoints by experienced laboratory and study-management teams. SOP-driven sample collection and processing, electronic data capture with full audit trail, and chain-of-custody documentation preserve data integrity and support sponsor audit and regulatory inspection readiness across U.S. and international jurisdictions. Animal welfare and preventive medicine remain the foundation of clean, interpretable laboratory data across rodent and NHP studies. AAALAC accreditation and USDA licensure, with OLAW assurance (PHS Policy) and IACUC oversight, back compliance. GLP and non-GLP study support available; some specialized assays are performed by or through qualified external partner laboratories.
In-life study execution and laboratory data generation are managed by the same team, reducing coordination gaps, sample handling steps, and the risk of documentation errors between functions.
Clinical pathology data are reviewed with veterinary clinical context, so findings are interpreted in the light of the animal’s condition, concurrent observations, and historical reference ranges.
Species-specific NHP clinical pathology reference ranges from our own study population provide a relevant interpretive baseline for toxicology and safety programs.
Electronic data capture, second-reviewer processes, and SOP-driven documentation apply consistently across GLP and non-GLP programs, not only when regulators are watching.
Laboratory support and biospecimen collection capabilities are designed to work together, so samples collected in-life are processed, labeled, and shipped under consistent chain-of-custody practices.
For specialized assays beyond our in-house scope, we coordinate with qualified bioanalytical, pathology, and immunological assay partners, managing logistics and data integration so sponsors have fewer vendors to manage.
Hematology (CBC with differential) and standard serum chemistry panels are performed in-house. Urinalysis is supported in-house. Specialized panels, coagulation, flow cytometry, and bioanalytical PK assays are coordinated through qualified external partner laboratories.
From clinical pathology through bioanalysis coordination and data reporting, our laboratory support capabilities are designed to deliver complete, audit-ready data packages for your preclinical program.