ScitoVation
ScitoVation is a Durham, NC-based CRO that uses New Approach Methods (NAMs), PBPK modeling, and AI to assess chemical safety for pharmaceutical, chemical, consumer product, and industry association clients, replacing animal testing with computational and cell-based approaches.
- Company typePrivate
- Founded2016
- HeadquartersDurham, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What ScitoVation does
ScitoVation, LLC is a contract research organization (CRO) headquartered in Durham, North Carolina, specializing in chemical safety assessment for pharmaceuticals, chemicals, food ingredients, cosmetics, agricultural chemicals, and consumer products using New Approach Methods (NAMs) that replace traditional animal testing with cell-based and computational techniques. The company was founded in 2016 by principals whose predecessor organization contributed to the National Academy of Sciences 2007 report "Toxicity Testing in the 21st Century," giving it a 40+ year lineage of expertise in regulatory toxicology. Its core technology portfolio centers on PLETHEM, an open-source physiologically based pharmacokinetic (PBPK) modeling platform developed under a memorandum of understanding with the US Environmental Protection Agency and comprising integrated modules for rapid PBPK, high-throughput in vitro to in vivo extrapolation (IVIVE), kinetically derived maximum dose (KMD) modeling, chemical clearance prediction, and ecotoxicological PBPK. Supporting tools include MoAViz (a mode-of-action gene expression visualization database), the TTC Data Mart (a 45,000-compound threshold of toxicological concern database), and the forthcoming ScitoSim AI Platform for predictive toxicology. The TgX DDI transcriptomic biomarker is currently undergoing FDA validation for genotoxicity assessment.
The company serves three primary verticals: pharmaceutical companies (lead compound screening, genotoxicity assessment, PBPK modeling for dose prediction, drug-drug interaction simulation), chemical manufacturers and consumer product companies (chemical safety assessment, NAMs implementation, regulatory submissions), and industry associations such as the American Chemistry Council, American Beverage Association, Cosmetic Europe, CAPHRA, RIFM, and NiPERA (consortium-funded research on member-relevant compounds). ScitoVation generates revenue through fee-for-service contract research priced via a Request For Quote process with multi-year project terms, supplemented by Small Business Innovation Research (SBIR) grants from the National Institute of Environmental Health Sciences (NIEHS). In February 2025 the company announced a strategic shift to focus exclusively on computational toxicology, concluding laboratory operations on March 31, 2025, and in November 2025 deepened a strategic partnership with Integral Consulting to deploy AI- and NAM-based chemical safety tools.
ScitoVation firmographics
Firmographics- Name
- ScitoVation
- Legal name
- SCITOVATION, LLC.
- Website
- https://scitovation.com
- Company type
- Private
- Founded year
- 2016
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- ScitoVation is a Durham, NC-based CRO that uses New Approach Methods (NAMs), PBPK modeling, and AI to assess chemical safety for pharmaceutical, chemical, consumer product, and industry association clients, replacing animal testing with computational and cell-based approaches.
- Ownership category
- akta.pro rank
ScitoVation industry classification
Industry- Product category
- Contract Research Services
- NAICS
- Research and Development in Biotechnology (except Nanobiotechnology) (541714), Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (54169)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)
- akta.pro primary industry
- Toxicology & Safety Assessment CROs (GLP) (HLAGAAAC)
Keywords
Where ScitoVation is headquartered
LocationHeadquarters
- HQ city
- Durham
- HQ country
- United States
- HQ region
- North America
Offices2 records
Markets served
ScitoVation business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales
Revenue model
- Contract Research Services: ScitoVation operates as a CRO providing fee-for-service research to assess chemical compound safety for pharmaceuticals, chemicals, food ingredients, cosmetics, and consumer products. Services include PBPK modeling, IVIVE, transcriptomics, cell-based assays, and genotoxicity testing.
- Government Research Grants: SBIR awards from National Institute of Environmental Health Sciences (NIEHS) to develop computational solutions for predicting human health effects.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom project-based pricing |
Go-to-market motion2 records
Distribution channels1 record
Marketing channels5 records
ScitoVation product offering
Product offeringCore offering
ScitoVation is a contract research organization (CRO) that helps clients assess the safety of pharmaceuticals, chemicals, food ingredients, cosmetics, and consumer products using new approach methods (NAMs) including cell-based assays, computational toxicology, PBPK modeling, and transcriptomics. The company offers a unified platform-plus-services model combining proprietary software tools (PLETHEM, MoAViz, TTC Data Mart, ScitoSim AI) with laboratory and computational research services for chemical safety assessment and regulatory submission support.
Product overview
ScitoVation is a contract research organization (CRO) offering a unified platform-plus-services model for chemical safety assessment. The core technology portfolio centers on PLETHEM, an open-source PBPK modeling platform, complemented by specialized tools including MoAViz (mode of action visualization), TTC Data Mart (threshold of toxicological concern), and ScitoSim™ AI Platform. ScitoVation provides laboratory services including in vitro compound screening, micronucleus assays, gene expression analysis, and hypothesis testing via RNAi/CRISPR, alongside computational services spanning PBPK modeling, IVIVE, toxicogenomic studies, and AI-assisted literature review. The offering integrates the PLETHEM modules (RapidPBPK, HT-IVIVE, KMD, Clearance Tool, Ecotox PBPK) with wet-lab capabilities and the new DRIIVE developmental platform to provide end-to-end NAM-based risk assessment.
Differentiator
Problem solved
Functional benefit
Brands
- MoAViz: Mode of Action Visualization tool - a database and visualization platform for comparing gene expression changes in response to chemical exposures in different model systems.
- PLETHEM
- TTC Data Mart
- ScitoSim™
Products and services
- PLETHEM (Population Life-course exposure to Health Effects Model) Flexible open-source PBPK modeling platform combining high-throughput exposure prediction and rapid physiologically-based pharmacokinetic modeling for chemical dosimetry and risk assessment, developed under memorandum of understanding with US EPA.
- MoAViz (Mode of Action Visualization) Interactive database and visualization tool for comparing gene expression changes in response to chemical exposures across different model systems and exposure scenarios.
- TTC Data Mart (Threshold of Toxicological Concern)
- ScitoSim AI Platform Next-generation AI platform for predictive toxicology, leveraging advanced molecular and computational toxicology tools to predict human health effects through NAMs.
- DRIIVE (Developmental PBPK/IVIVE Platform) Developmental PBPK/IVIVE platform for traceable, regulator-ready evidence pipelines supporting developmental and reproductive toxicology assessments.
- PBPK Modeling Services Physiologically-based pharmacokinetic modeling for interspecies extrapolation, intra-species variability, route-to-route extrapolation, high-to-low dose extrapolation, and population variability assessment.
- IVIVE Services In vitro to in vivo extrapolation for translating large-scale in vitro toxicity assay results into in vivo exposure context, including high-throughput IVIVE and quantitative IVIVE (Q-IVIVE).
- Toxicogenomic Studies Cutting-edge technologies for probing molecular changes to identify perturbations related to apical effects using Adverse Outcome Pathway frameworks.
- Compound Screening Service In vitro cell-based assays for go/no-go decision making, compound ranking by cytotoxicity, and range-finding for concentrations in complex experiments, screening up to 30 compounds per batch.
- Lead Compound Assessment Characterization of safety endpoints including cell viability, cell cycle, kinetic proliferation, integrated stress response, and mitochondrial fragmentation using high-content imaging (Phoenix Opera).
- Micronucleus Assay Flow cytometry-based in vitro micronucleus assay using human TK6 or HepaRG cells for genotoxicity assessment compliant with OECD 487.
- QSAR Mutagenicity Screening Computational tools based on compound structure highly predictive of bacterial mutagenicity testing (Ames Test) for early candidate triage.
- Gene Expression Analysis Differential gene expression analysis using qRT-PCR (targeted) and RNA-seq (omics scale) with computational expertise for developing biologically meaningful hypotheses.
- Hypothesis Testing (RNAi and Gene Editing) Protein expression manipulation through lentiviral transduction for overexpression/shRNA knockdown and CRISPR/Cas9 for knockout cell lines.
- Custom Assays Bespoke cell-based assays designed to measure specific mode of action endpoints, including steatosis and uterine assays.
- AI-Assisted Literature Review Research scientist-led initiative to modernize toxicology evidence gathering through automation and AI-assisted curation for DART, IVIVE, and PBPK modeling.
Quantifiable outcome
- Removed artificial adjustment factor for children in pyrethroid risk assessment after EPA review of ScitoVation's PBPK modeling
- +2 more outcomes
Companies that use ScitoVation
Customer profileNamed customers7 records
Segments3 records
Ideal customer profiles3 records
ScitoVation technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability8 records
Feature6 records
ScitoVation partnerships and signals
Strategic signalPartnerships
Six partnerships are on record, tiered core and major.
- Integral Consulting Inc.coreDeepened strategic partnership deploying advanced molecular and computational toxicology tools using AI and NAMs to accelerate chemical safety assessments. Integrated tools enhance toxicology, pharmacokinetics, exposure, and risk assessment processes for faster chemical safety decisions.
- Integral Consulting Inc.coreStrategic alliance to advance innovation in health risk assessment, combining ScitoVation's computational toxicology expertise with Integral Consulting's engineering and environmental science capabilities.
- HESI (Health and Environmental Sciences Institute)majorActive participation in committees developing standards for regulatory submission of PBPK models. Collaboration yielded a consensus paper on transcriptomics, inhalation, and genotoxicity methods.
- MIT (Bevin Engelward)majorCollaboration with MIT and University of Ottawa (Carole Yauk) to develop a human-relevant genotoxicity testing platform using metabolically competent human hepatocytes integrated with rapid detection of genotoxicity and mode-of-action based genomic profiling.
- OECD Genetic Toxicology Expert Working GroupmajorDr. Leslie Recio serves on this working group since 2014, contributing to international standards for genetic toxicology testing.
- US Environmental Protection Agency (EPA)majorCollaborated on PBPK model development under memorandum of understanding. EPA Office of Pesticides utilizes PLETHEM as open-source platform for evaluations. ScitoVation data submitted to EPA influenced regulatory decisions on pyrethroids.
Scale indicators5 records
Recent moves7 records
Expansion highlights6 records
ScitoVation competitors and assessment
Company assessmentDirect peers
- ToxStrategies: Private toxicology and risk assessment consulting firm offering PBPK modeling, mode-of-action, and regulatory toxicology services to chemicals, pharma, and consumer products clients. Closely comparable in scope, client mix, and service model to ScitoVation's NAMs offering.
- Inotiv (formerly ILS): Preclinical and genetic toxicology CRO where ScitoVation's CSO Dr. Leslie Recio previously served as CSO/Director. Provides genetic toxicology, regulatory toxicology, and NTP-aligned testing — overlapping directly with ScitoVation's genotoxicity and OECD-submission capabilities.
- Gradient Analytics: Environmental and human health risk assessment consultancy providing toxicology, exposure, and PBPK modeling services to chemical, consumer products, and legal clients. Highly comparable boutique competitor in the same NAMs/mode-of-action space.
- Cardno ChemRisk: Toxicology and risk assessment consulting practice providing chemical safety, exposure, and PBPK services to industry and legal clients. Comparable boutique in NAMs, mode-of-action, and regulatory toxicology.
Broad incumbents
- Ramboll (Environ): Global engineering and environmental consulting firm whose health sciences practice conducts chemical risk assessment, exposure science, and toxicology for industrial and government clients — increasingly intersecting with NAMs work.
- Charles River Laboratories: One of the largest preclinical CROs globally with deep safety assessment, genetic toxicology, and PBPK capabilities. Competes with ScitoVation for outsourced chemical and pharmaceutical safety work but at substantially greater scale.
- Pharmaron: Integrated CRO with significant in vitro/in vivo toxicology, DMPK/PBPK, and computational toxicology capabilities serving both pharmaceutical and chemical clients. Competes for outsourced safety assessment and PBPK modeling engagements.
- Exponent: Large engineering and scientific consulting firm with a health sciences practice that conducts toxicology, PBPK, and risk assessment work for chemicals, pharma, and product liability clients. A broader, more diversified competitor operating in overlapping NAMs engagements.
- Battelle: Large nonprofit contract research organization with a dedicated life sciences and toxicology practice. Competes for government and chemical-industry toxicology contracts and operates in adjacent areas such as inhalation toxicology, environmental health, and PBPK modeling.
Regional players
- RTI International: Research Triangle Park-based nonprofit research institute with significant environmental health, statistical, and toxicology capabilities. Geographic and talent-market overlap with ScitoVation, and competing for federal grants and chemical-industry research dollars.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks5 records
Key highlights6 records
Customer concentration
ScitoVation social profiles
Digital presenceScitoVation financial estimates
Financial estimateRevenue estimate
Valuation estimate
ScitoVation leadership team
Management profileNumber of profiles
Profiles6 records
ScitoVation funding detail
Funding detailFunding overview
Funding rounds3 records
Investors1 record
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ScitoVation M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ScitoVation
What does ScitoVation do?
ScitoVation is a contract research organization (CRO) that helps clients assess the safety of pharmaceuticals, chemicals, food ingredients, cosmetics, and consumer products using new approach methods (NAMs) including cell-based assays, computational toxicology, PBPK modeling, and transcriptomics. The company offers a unified platform-plus-services model combining proprietary software tools (PLETHEM, MoAViz, TTC Data Mart, ScitoSim AI) with laboratory and computational research services for chemical safety assessment and regulatory submission support.
Is ScitoVation a public or private company?
ScitoVation is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was ScitoVation founded?
ScitoVation was founded in 2016. It employs 11 to 50 people.
Where is ScitoVation based?
ScitoVation is headquartered in Durham, United States, in the North America region.
How does ScitoVation make money?
Two revenue lines are on record. Contract Research Services are the primary driver. The others are government Research Grants.
Who are ScitoVation's main competitors?
Direct peers on record are ToxStrategies, Inotiv (formerly ILS), Gradient Analytics and Cardno ChemRisk. Broad incumbents are Ramboll (Environ), Charles River Laboratories, Pharmaron, Exponent and Battelle. RTI International is listed as a regional player.
Does ScitoVation have an API?
No public API is recorded for ScitoVation.
What industry is ScitoVation in?
ScitoVation's product category is Contract Research Services. Its primary akta.pro industry code is HLAGAAAC, Toxicology & Safety Assessment CROs (GLP). Its NAICS code is 541714 and its SIC code is 8731.