InVivo Biosystems is a contract research organization in Eugene, Oregon[S1] whose reviewed model pages focus on two non-mammalian species, the zebrafish (Danio rerio) and the nematode C. elegans.[S6] It describes itself as building "the infrastructure for translational discovery?delivering fast, scalable whole-organism models to accelerate development and de-risk early decisions."[S1] The company was founded as NemaMetrix, merged with Knudra Transgenics in 2017 and adopted its current name in March 2020;[S3] a 2020 announcement states that it "was founded in 2011 as a spin-off of the University of Oregon,"[S3] while a statistics block on the About page shows 2010 as the year established.[S2] This profile summarizes the services, platforms, stated compliance information, and company facts most relevant to US sponsors.
Services relevant to US drug developers
Model generation with CRISPR
The company offers custom zebrafish and C. elegans strain generation. For knock-ins it states that "C. elegans CRISPR knock-in enables researchers to insert specific DNA sequences at targeted genomic locations with high efficiency,"[S8] offering fluorescent tags, immunotags, degron tags, point mutations and MosSCI transgenesis, in full-build, candidate-line or custom injection-mix tiers.[S8] Knockout strains are offered in both species, and the company describes MIC-Drop as a multiplexed platform "exclusively licensed from the University of Utah" that "enables high-throughput gene editing using CRISPR-loaded microdroplets."[S5] It states that it delivers "over 3,000 C. elegans transgenic lines to researchers"[S6] as a licensed CRISPR solutions provider; a separate statistics block cites more than 4,000 preclinical models created.[S2]
Variant testing, efficacy screening, and toxicity
Gene-humanized strains are used to test patient variants, including variants of unknown significance, with the company stating that it "builds humanized models to study gene function, variant impact, and disease biology in a whole-organism context"[S7] through whole gene humanization or point mutation humanization.[S7] Efficacy work is sold as a set of named studies covering vitality and lifespan, antioxidant capacity, mitochondrial function, gene expression signature by RNA-seq, and microbiome studies, with the company stating that it integrates "whole-organism models, miniaturized cell-based assays, and reporter systems to measure functional response in living biology."[S9] Toxicity screening uses zebrafish embryos, and the company notes that its protocol "is more comprehensive than the set of 4 endpoints prescribed by the OECD FET 236,"[S10] referring to the OECD fish embryo acute toxicity test guideline. Compound library and biologics screening is offered at medium throughput up to biosafety level 2.[S11] Named therapeutic areas include epilepsy, Parkinson's disease, Alzheimer's disease, cancer, ocular disease and rare monogenic and metabolic disorders.[S4]
Where these models fit in a regulatory program
Sponsors should determine with FDA whether data from a proposed non-mammalian model can support a particular part of the nonclinical package, rather than assuming a general rule. The FDA Modernization Act 2.0, enacted as section 3209 of the Consolidated Appropriations Act, 2023, changed the statutory definition so that a nonclinical test supporting an investigational new drug application need not be an animal test.[S14] It did not direct FDA to accept any particular alternative method, and it did not remove FDA's authority to ask for specific nonclinical data. Sponsors should therefore treat data from these models as supporting evidence and agree the regulatory role of each study with FDA rather than assuming substitution.
Quality, compliance, and animal welfare (as stated by the company)
The pages reviewed for this profile do not state that the company conducts studies under Good Laboratory Practice regulations, and they do not mention AAALAC International accreditation, USDA registration, an Animal Welfare Assurance with NIH OLAW, or an Institutional Animal Care and Use Committee. Oversight requirements for zebrafish and C. elegans differ from those for mammals under the Animal Welfare Act and the PHS Policy,[R4][R5] so the absence of these statements is not by itself surprising; it is also not confirmation that no oversight applies. Sponsors who need documented GLP status or a specific oversight arrangement should ask the company directly. 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]
Species named on the reviewed model pages: zebrafish (Danio rerio) and C. elegans.[S6] No mammalian model service was found on those pages; that is not a finding that none exists
Platforms
RapidGen preclinical platform; MIC-Drop multiplexed CRISPR, exclusively licensed from the University of Utah; gene-humanized models[S4][S5]
Track record (company statements)
400+ clients served; 600+ studies delivered; 10+ patents issued; over 3,000 C. elegans transgenic lines delivered[S4][S6]
FDA ? "Is It Really FDA Approved?" (FDA does not approve health care providers, including laboratories; registration does not denote approval); FDA Compliance Program 7348.808 (GLP inspections of nonclinical laboratories). https://www.fda.gov/consumers/consumer-updates/it-really-fda-approved (accessed 2026-09-03)
3 Recommended Contract Research Organizations
for Non-Clinical Studies
— by Target goal and Expertise
In non-clinical development, the choice of contract research organization shapes the quality of the data and the time it takes to reach the next decision. Below, three CROs are introduced by the type of study they support: pharmacology (efficacy) studies, safety studies, and pharmacokinetic (PK/PD) studies. Each summary describes the services the company offers so that you can match a provider to your target and development objective.
Pharmacology (Efficacy) StudiesDisease-Relevant Models for Translational Drug Evaluation
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/)
SMC Laboratories, Inc.
SMC Laboratories is a specialized non-clinical CRO focused on in vivo pharmacology and efficacy studies using disease-relevant animal models, particularly in fibrosis, inflammation, metabolic diseases, and oncology.
Areas of Expertise
Disease-Relevant Model Portfolio
SMC Laboratories offers models covering the liver, lung, kidney, intestine, and oncology. Its portfolio includes the proprietary STAM™ model for MASH, fibrosis, and hepatocellular carcinoma.
Study Design Based on Target Biology
Study plans are developed around the target biology, mechanism of action, disease stage, and development objective. Pharmacological endpoints can be combined with histopathology, biomarkers, and disease-specific readouts.
Support from Target Validation to Proof of Concept
With experience from more than 1,000 studies for clients in 30 countries, SMC Laboratories supports programs from target validation and candidate selection through in vivo proof-of-concept studies.
Safety StudiesComprehensive Safety Assessment for Preclinical Development
Reference: Charles River Laboratories official website (https://www.criver.com/)
Charles River Laboratories
Charles River provides non-clinical toxicology and safety assessment services for programs ranging from exploratory safety studies to IND-enabling development.
Areas of Expertise
General Toxicology Across Study Designs
Services include single- and repeat-dose toxicology, dose-range finding, and general toxicology studies across multiple species and administration routes.
Non-GLP and GLP Study Support
Charles River supports both non-GLP and GLP studies, allowing sponsors to progress from early safety characterization to studies intended for regulatory submissions.
Integrated IND-Enabling Safety Assessment
Toxicology studies can be integrated with toxicokinetics, clinical pathology, histopathology, and safety pharmacology to support interpretation and IND-enabling safety packages.
Pharmacokinetic (PK/PD) StudiesConnecting Drug Exposure with Pharmacological Response
Reference: Inotiv official website (https://www.inotiv.com/)
Inotiv
Inotiv provides integrated PK/PD, DMPK, and bioanalytical services to characterize drug exposure and its relationship with pharmacological response.
Areas of Expertise
Pharmacokinetic Characterization
PK studies characterize exposure, half-life, clearance, and other pharmacokinetic parameters needed to understand how a candidate behaves in the selected model.
Exposure–Response Evaluation
Pharmacokinetic data can be combined with pharmacodynamic endpoints and bioanalysis to evaluate the relationship between drug exposure and pharmacological response.
Integrated DMPK and Development Support
Integrated DMPK, pharmacology, and safety information supports candidate comparison, dose selection, dosing-frequency optimization, and decisions about subsequent preclinical development.
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