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 drug discovery, the quality and efficiency of non-clinical studies have a direct impact on clinical success rates, development costs, and overall length of time required in R&D.
In recent years, there has been more demand for clinically relevant data, globally accepted reliability, and accurate early-stage screening.
Thus, it is more important than ever to select the right CRO (Contract Research Organization) for strategic approach.
In this article, we highlight three CROs with proven technical capabilities, expertise, and long standing track records. These are our TOP 3 choices based on their capabilities and the specific target goals of the researchers for their non-clinical studies.
Pharmacology (Efficacy) Studies Replicate unknown pathological models and Discovery to clinically oriented drug evaluation
SMC Laboratories, Inc.
Reference: SMC Laboratories, Inc. official website (https://www.smccro-lab.com/jp/)
SMC Laboratories, Inc. has established a disease models using patented mouse technologies.
The company has established proprietary pathological models—particularly in liver disease and fibrosis—and continues to expand their approach across a wide range of models in cancer, inflammation, and metabolic diseases.
From exploratory research to clinically oriented efficacy evaluation, SMC offers customized study designs, dosing strategies, and evaluation analysis tailored to each project.
Their collaborative approach allows researchers to discuss and refine study plans together with SMC’s expert scientists.
With flexible small-scale study options and strong technical support, SMC Laboratories, Inc. is an ideal partner for start-ups, biotech ventures, and academic institutions alike.
Safety Studies Comprehensive Safety Evaluation for FIH Applications
Labcorp Holdings Inc. (Labcorp Drug Development)
Reference: Labcorp Holdings Inc. official website (https://jp.labcorp.com/)
Labcorp Holdings Inc. provides a fully integrated GLP testing system aligned with international regulatory standards, including FDA, EMA, and PMDA requirements.
All studies are conducted under ICH-compliant quality assurance, making it ready for data submission.
The company has extensive expertise in long-term toxicity studies such as Segment I–III reproductive and carcinogenicity studies, as well as 2-year chronic toxicity assessments.
Labcorp Holdings Inc.’s comprehensive approach enables sponsors to efficiently outsource the entire preclinical package from toxicology, toxicokinetic (TK), and safety pharmacology study design to execution. This accelerates a path to First-in-Human (FIH) trials.
For most of the global drug developers, this all-in-one service structure minimizes cost, risk, and expedite the time before advancing to clinical phase.
Pharmacokinetic (PK/PD) Studies High-Precision Bioanalysis for Clinically Predictive PK/PD Evaluation
PhoenixBio Co., Ltd.
Source: PhoenixBio Co., Ltd. Official Website (https://phoenixbio.co.jp/)
PhoenixBio Co., Ltd. offers pharmacokinetic and hepatic metabolism studies using their proprietary PXB-mouse®, a humanized-liver chimeric mouse model. This platform enables the acquisition of data with high clinical correlation in ADME, drug–to–drug interaction studies, bridging the gap between preclinical and clinical stages.
With advanced LC-MS/MS-based bioanalysis, PhoenixBio Co., Ltd. provides a seamless workflow from plasma concentration measurement and metabolite identification to quantitative validation.
The company offers an integrated evaluation analysis covering pharmacokinetics, hepatotoxicity, and safety with flexibility to accommodate complex modalities such as oligonucleotide and middle-molecule therapeutics.
For compounds where hepatic metabolism is a development bottleneck—or where quantitative, reproducible exposure data are critical—PhoenixBio Co., Ltd. delivers unmatched analytical precision and consistency.
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