ValidCare
Validcare is a performance-based Contract Research Organization that delivers real-time clinical trials through its proprietary SmartSource™ platform, serving emerging biotech, mid-market pharma, medical device, and nutraceutical sponsors across 40+ countries.
- Company typePrivate
- Founded2014
- HeadquartersNew Castle, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What ValidCare does
Validcare, LLC is a performance-based Contract Research Organization founded in 2014 and headquartered in Castle Pines, Colorado, that delivers Real-Time Clinical Trials to emerging biotech, mid-market pharmaceutical, medical device, nutraceutical, and academic sponsors. The company operates a unified proprietary technology platform called SmartSource™, a 21 CFR Part 11-compliant cloud-based clinical trial system that integrates CTMS, EDC/eCRF, ePRO, eCOA, eConsent, randomization/IRT, safety/PV, eTMF/eISF, digital recruitment, and protocol deviation modules into a single architecture. The platform's distinguishing technical feature is Source Data Collection at the point of care, in which investigator entry serves as the source record — eliminating transcription and collapsing SDV scope — combined with continuous cleaning that achieves database lock in days after Last Patient Last Visit rather than weeks or months.
Validcare generates revenue through three streams: (1) full-service CRO engagements delivered under performance-based fixed-fee contracts covering protocol development, regulatory submissions, site management, monitoring, data management, biostatistics, and medical writing; (2) SmartSource platform licensing as a white-labelable platform-as-a-service (e.g., Florida International University's 'FIU Study'); and (3) risk-sharing commercial structures that include equity participation, shared enrollment risk, and milestone-based payments rather than hourly billing. The company maintains legal entities in 8 countries and operational reach across 40+ countries, with therapeutic depth spanning 20+ areas including women's health, oncology, cardiovascular, neurology, gastroenterology, and endocrinology.
The go-to-motion is direct enterprise sales supported by inside-sales inquiry handling, industry event presence (including the JPMorgan Healthcare Conference), content marketing via blog and newsletter, and partnership channels that double as distribution into academic institutions and emerging markets. Validcare is privately held with no disclosed external funding rounds, no parent company, and no subsidiaries beyond the integrated Real-World Research Ltd capability acquired in 2022.
ValidCare firmographics
Firmographics- Name
- ValidCare
- Legal name
- Validcare, LLC
- Website
- https://validcare.com
- Company type
- Private
- Founded year
- 2014
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Validcare is a performance-based Contract Research Organization that delivers real-time clinical trials through its proprietary SmartSource™ platform, serving emerging biotech, mid-market pharma, medical device, and nutraceutical sponsors across 40+ countries.
- Ownership category
- akta.pro rank
ValidCare industry classification
Industry- Product category
- Clinical Research Organization (CRO) Services
- NAICS
- Scientific Research and Development Services (5417), Custom Computer Programming Services (541511)
- SIC
- Services-Computer Programming, Data Processing, Etc. (7370), Services-Misc Health & Allied Services, Nec (8090)
- akta.pro primary industry
- Clinical CROs (Phase I–IV) (HLAGAAAA)
- akta.pro secondary industries
- Decentralized/Hybrid Trial Enablement (DCT) Platforms (HLACAOAL), Patient Recruitment, Site Feasibility & Trial Enablement CROs (HLAGAAAI), Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL)
Keywords
Where ValidCare is headquartered
LocationHeadquarters
- HQ city
- New Castle
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
ValidCare business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Operations, Marketing or Sales, Others
Revenue model
- Full-Service CRO Services: Validcare operates as a full-service Contract Research Organization providing end-to-end clinical trial services including protocol development, regulatory support, site management, clinical monitoring, data management, biostatistics, medical writing, and safety management under a single contract.
- SmartSource™ Platform Licensing: The SmartSource Clinical Trial Platform is offered as a platform-as-a-service (PaaS), available for white-labeling by partners and institutions (e.g., FIU white-labeled as 'FIU Study').
- Performance-Based Contracts: Fixed-fee contracts for setup and monthly study management with transparent pass-through costs and simple admin fee. Risk-sharing options include partial payment in equity, shared risk on enrollment rates, and milestone-based payments. No hourly billing or catch-all project management line items.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Multi-year contract | Fixed-Fee Setup and Management |
| Outcome Based/ Performance | Multi-year contract | Risk-Sharing Options |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels5 records
ValidCare product offering
Product offeringCore offering
Validcare operates as a performance-based, full-service Contract Research Organization (CRO) delivering end-to-end clinical trial services — including protocol development, regulatory support, site management, clinical monitoring, data management, biostatistics, medical writing, and safety management — underpinned by its proprietary SmartSource™ Clinical Trial Platform. The unified cloud platform enables Source Data Collection at the point of care, continuous cleaning, real-time stakeholder dashboards, and database lock in days after Last Patient Last Visit, delivered under fixed-fee, performance-based contracts with risk-sharing options.
Product overview
Validcare operates as a Performance-Based CRO delivering Real-Time Clinical Trials through its SmartSource™ Clinical Trial Platform — a unified platform-plus-modules architecture. The core SmartSource™ platform integrates CTMS, EDC (eCRF), ePRO, eCOA, eConsent, Randomization/IRT, Safety/PV Workflow, eTMF/eISF, Digital Recruitment, and Protocol Deviations modules into a single system. This platform powers Source Data Collection at the point of care and enables protocol-governed real-time access for sponsors, sites, participants, IRBs, and regulators. Validcare's Full-Service CRO offering combines this technology with comprehensive clinical trial services (protocol development, regulatory support, site management, monitoring, data management, biostatistics, medical writing) delivered under performance-based fixed-fee contracts.
Differentiator
Problem solved
Functional benefit
Products and services
- Full-Service CRO Services End-to-end clinical trial services including protocol development, regulatory submissions, site selection and management, clinical monitoring, data management, biostatistics, medical writing, and safety/pharmacovigilance delivered as a single accountable engagement under performance-based contracting. Targeted at biotech, pharmaceutical, medical device, nutraceutical, and academic sponsors running Phase I–III trials, decentralized studies, IDE submissions, and real-world evidence studies.
- SmartSource™ Clinical Trial Platform Unified, cloud-based, 21 CFR Part 11 compliant platform-as-a-service integrating CTMS, EDC/eCRF, ePRO, eCOA, eConsent, Randomization/IRT, Safety/PV Workflow, eTMF/eISF, Digital Recruitment, and Protocol Deviations modules. Enables Source Data Collection at the point of care, continuous cleaning, AI-assisted anomaly detection, real-time sponsor dashboards, and protocol-governed stakeholder access for sponsors, sites, participants, IRBs, and regulators. Available for white-label PaaS deployment by partners and institutions (e.g., FIU's 'FIU Study').
- Source Data Collection Service Operational methodology and service whereby clinical data are captured directly from investigators and patients at the point of care through the SmartSource platform, eliminating transcription errors, collapsing SDV scope, and enabling continuous cleaning throughout study execution. Delivered as part of Validcare's full-service CRO engagements and available wherever SmartSource is deployed.
Quantifiable outcome
- Database lock achieved in days after Last Patient Last Visit - vs weeks/months traditional approach
- +3 more outcomes
Companies that use ValidCare
Customer profileNamed customers9 records
Segments4 records
Ideal customer profiles2 records
ValidCare technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration6 records
AI capability2 records
Feature6 records
ValidCare partnerships and signals
Strategic signalPartnerships
Eight partnerships are on record, tiered core.
- Univo IRBcoreStrategic alliance to provide emerging biotech and biopharma sponsors with a modernized, end-to-end experience making Real-Time Clinical Trials a reality. Integration of Univo IRB's efficient IRB model with Validcare's SmartSource™ platform delivers unprecedented real-time visibility into study data across the entire trial lifecycle for sponsors, investigators, and regulators.
- Algernon NeuroSciencecoreCRO partnership for Phase 2a clinical study examining DMT treatment in stroke patients. Validcare committed to $170,000 equity investment in AGN Neuro staged progressively as the study advances. Alignment of financial incentives toward timely completion, budget adherence, and robust data quality.
- CoologicscoreCRO partnership for multi-center prospective study involving 160 women evaluating Vlisse vaginal cooling device for vulvovaginal candidiasis, with findings intended to support FDA market approval submission.
- TECLenscoreCRO partnership for presbyopia study evaluating proprietary qCXL™ technology. Services include protocol development, electronic source data collection, data management, and statistical analysis.
- Bubs AustraliacoreCRO partnership for 440-infant Growth Monitoring Study across 13 U.S. sites to support FDA market authorization for Bubs infant formula products. Study targeted completion before FDA September 2024 deadline.
- Farmacon GlobalcoreStrategic partnership to enhance clinical trial execution in Latin America and emerging markets. Farmacon specializes in accelerating trials with expertise in rare disease, cancer, immunology, and infectious disease research. Partnership enables electronic case report forms, e-diaries, and real-world evidence applications.
- Florida International UniversitycoreSole source agreement where FIU white-labels Validcare's platform as 'FIU Study' for hybrid and decentralized clinical trials. Platform supports iOS/Android apps, investigator portal, and support services across the institution.
- Garden of LifecorePartnership for largest clinical trial ever performed for women studying Dr. Formulated Women's Once Daily Probiotic supplement. Leverages Validcare's decentralized trial technology via branded mobile app for Android and iOS.
Scale indicators6 records
Recent moves6 records
Expansion highlights7 records
ValidCare competitors and assessment
Company assessmentDirect peers
- Medpace Holdings: Mid-sized, science-led full-service CRO with a strong technology backbone and a reputation for predictable, fixed-fee trial execution — the closest direct analogue to Validcare's performance-based, tech-embedded model.
- Worldwide Clinical Trials: Mid-market full-service CRO focused on complex Phase II/III trials across multiple therapeutic areas, comparable to Validcare in scale, sponsor mix, and reliance on differentiated operational models.
Broad incumbents
- ICON plc: Top-five global CRO offering full-service clinical development plus laboratory and commercial services; broad incumbent competing across the same therapeutic and trial phases as Validcare.
- IQVIA: Largest CRO and life-sciences technology platform — competes head-on with Validcare across full-service operations, eClinical software, and DCT enablement, but at far greater scale and breadth.
- Parexel International: Full-service global CRO with strong biotech sponsor relationships and growing decentralized trial capabilities — directly comparable in target customer segment and trial complexity.
- Charles River Laboratories: Early-stage CRO services and preclinical solutions provider whose discovery-to-Phase II suite overlaps with Validcare's biotech and emerging-sponsor focus areas.
- Veeva Systems: Life-sciences cloud platform with CTMS, eTMF, and clinical operations suites — competing for the same CRO technology budgets while extending into operational software adjacent to Validcare's stack.
Emerging players
- Clario: Specialized eClinical technology provider (eCOA, cardiac safety, imaging) with similar decentralized trial DNA — overlaps with Validcare on the SmartSource platform layer more than on full-service operations.
- Medidata Solutions (Dassault Systèmes): Enterprise EDC and clinical cloud platform; competing with the SmartSource™ platform for sponsor eClinical mandates that anchor Validcare's performance-based CRO offering.
- Biofourmis: Decentralized and hybrid trial enablement vendor leveraging connected biosensors and AI — intersects with Validcare's DCT capabilities and continuous-data-stream thesis but does not provide full-service CRO operations.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key highlights7 records
Customer concentration
ValidCare social profiles
Digital presenceValidCare financial estimates
Financial estimateRevenue estimate
Valuation estimate
ValidCare leadership team
Management profileNumber of profiles
Profiles3 records
ValidCare funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
ValidCare M&A and investment
M&A and investmentM&A
Investments1 record
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about ValidCare
What does ValidCare do?
Validcare operates as a performance-based, full-service Contract Research Organization (CRO) delivering end-to-end clinical trial services — including protocol development, regulatory support, site management, clinical monitoring, data management, biostatistics, medical writing, and safety management — underpinned by its proprietary SmartSource™ Clinical Trial Platform. The unified cloud platform enables Source Data Collection at the point of care, continuous cleaning, real-time stakeholder dashboards, and database lock in days after Last Patient Last Visit, delivered under fixed-fee, performance-based contracts with risk-sharing options.
Is ValidCare a public or private company?
ValidCare is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was ValidCare founded?
ValidCare was founded in 2014. It employs 11 to 50 people.
Where is ValidCare based?
ValidCare is headquartered in New Castle, United States, in the North America region.
How does ValidCare make money?
Three revenue lines are on record. Full-Service CRO Services are the primary driver. The others are smartSource™ Platform Licensing and performance-Based Contracts.
Who are ValidCare's main competitors?
Direct peers on record are Medpace Holdings and Worldwide Clinical Trials. Broad incumbents are ICON plc, IQVIA, Parexel International, Charles River Laboratories and Veeva Systems. Emerging players are Clario, Medidata Solutions (Dassault Systèmes) and Biofourmis.
Does ValidCare have an API?
No public API is recorded for ValidCare.
What industry is ValidCare in?
ValidCare's product category is Clinical Research Organization (CRO) Services. Its primary akta.pro industry code is HLAGAAAA, Clinical CROs (Phase I–IV), with a secondary code of HLACAOAL, Decentralized/Hybrid Trial Enablement (DCT) Platforms. Its NAICS code is 5417 and its SIC code is 7370.