Instat Clinical Research

What Instat Clinical Research does

Instat Clinical Research is a U.S.-based contract research organization originally founded in 2003 as a biometrics-focused CRO, now operating as a wholly-owned subsidiary of Veristat LLC following acquisition and full brand integration under the Veristat name. The entity is domiciled in Massachusetts, with European operations anchored by Veristat International Limited in London, and additional operational reach into Switzerland and Canada. Through its parent, Instat/Veristat functions as a global full-service CRO delivering integrated solutions across the entire clinical development, regulatory registration, and commercialization lifecycle.

The company's service portfolio is organized into core offerings — Biometrics (data management, biostatistics, statistical programming, standards implementation), Clinical Operations (project management, monitoring, patient recruitment and retention), Regulatory Affairs (strategy, marketing applications, CMC, agency meetings, regulatory publishing, medical devices/IVDs), Medical Affairs and Pharmacovigilance, Medical/Regulatory Writing, Strategic Consulting (adaptive design, statistical power), Quality Assurance & Compliance, and FSP/Resourcing — and specialized solutions including Decentralized Trials, Rescue Trials, Natural History Trials, Cell and Gene Therapies, Vaccine Trials, and Rare Diseases. Therapeutic expertise spans oncology/hematology, neurology/psychiatry, endocrine/metabolic, inflammation/immunology, infectious disease, and cardiovascular disease. Proprietary technical capabilities include an automated DBL-to-TLF processing pipeline that compresses reporting timelines from weeks to days, and a decentralized clinical trial platform supporting virtual and central site models for advanced therapy products.

Commercially, the company operates a professional services revenue model with project-based and FSP/resourcing engagements, executed through enterprise field sales and a formal RFP/RFI process targeting pharmaceutical, biotechnology, medical device, and diagnostic company sponsors. The GTM is content-led, supported by a blog, podcast series, webinars, conference presence, and monthly newsletter focused on regulatory science thought leadership. Pricing is quote-based and not publicly disclosed. Data privacy and compliance posture is anchored by EU-U.S. DPF, UK Extension, Swiss-U.S. DPF, and GDPR certifications, enabling cross-border personal data processing for global trial programs. The company is privately held with no disclosed funding rounds, no public revenue figures, and leadership represented by co-founders Dave Koster, Mark McBride, and Kyle McBride.

Name

Instat Clinical Research

Legal name

Veristat LLC

Website

https://instat.com

Company type

Private

Founded year

2003

Operating status

Operating

Headcount range

11–50 employees

Ownership category

akta.pro rank

Product category

Contract Research Organization Services

NAICS

Scientific Research and Development Services (5417), Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (541690), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Services-Commercial Physical & Biological Research (8731), Services-Management Consulting Services (8742)

akta.pro primary industry

Clinical CROs (Phase I–IV) (HLAGAAAA)

akta.pro secondary industries

Clinical Data Management, Biostatistics & Statistical Programming CROs (HLAGAAAF), Medical Writing & Regulatory Submission Support CROs (HLAGAAAG), Specialty Therapeutic-Area CROs (e.g., oncology/rare disease) (HLAGAAAL), Clinical Quality Assurance (GCP QA, TMF/QMS oversight) (HLAGAKAI), Pharmacovigilance, Risk Management & Medical Affairs CROs (HLAGAAAH)

Keywords

• Clinical research services
• Contract research organization
• Clinical data management
• Regulatory affairs services
• Biometrics services

Headquarters

HQ city

Chatham

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Infrastructure

Revenue model

1. Full-Service CRO Services: Comprehensive clinical research organization services spanning the entire drug development lifecycle including biometrics, regulatory affairs, clinical operations, and pharmacovigilance. Revenue is generated through project-based contracts with pharmaceutical and biotechnology sponsors.
2. Strategic Consulting: Regulatory strategy, adaptive trial design, and statistical consulting services provided on a project or retainer basis.
3. FSP/Resourcing: Functional Service Provider solutions providing dedicated staffing and resourcing for client development programs.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

Instat Clinical Research (now operating as Veristat) is a full-service Contract Research Organization (CRO) that delivers clinical trial services across the entire clinical development, regulatory registration, and commercialization lifecycle. Its offering spans biometrics (data management, biostatistics, statistical programming), clinical operations (project management, monitoring, patient recruitment), regulatory affairs (consulting, marketing applications, CMC, agency meetings), medical affairs, medical writing, pharmacovigilance, quality assurance, strategic consulting, and FSP/resourcing solutions. Services are sold primarily to pharmaceutical, biotechnology, medical device, and diagnostic sponsors.

Product overview

Instat Clinical Research is now Veristat, a full-service Contract Research Organization (CRO) and consultancy offering integrated solutions across the entire clinical development, regulatory registration, and commercialization lifecycle. The company's portfolio consists of core service offerings including Biometrics (data management, biostatistics, statistical programming, standards implementation), Clinical Operations (project management, monitoring, patient recruitment), Regulatory Affairs (consulting, marketing applications, CMC, agency meetings, regulatory publishing, medical devices), Medical Affairs (safety, data monitoring, medical monitoring), Medical/Regulatory Writing, Strategic Consulting (adaptive designs, statistical power), Pharmacovigilance, Quality Assurance & Compliance, FSP/Resourcing, and Full-Service Clinical Trials. These core services are organized into specialized solutions including Decentralized Trials, Rescue Trials, Natural History Trials, Cell and Gene Therapies, Vaccine Trials, and Rare Diseases solutions. The company also maintains therapeutic expertise across Oncology/Hematology, Neurology/Psychiatry, Endocrine/Metabolic, Inflammation/Immunology, Infectious Disease, and Cardiovascular Disease. The offering operates as a unified service portfolio rather than a modular software platform, providing end-to-end support from biometrics through regulatory submission.

Differentiator

Problem solved

Functional benefit

Products and services

• Biometrics Services Comprehensive data management, biostatistics, statistical programming, and standards implementation services for clinical trial data collection, analysis, conversion, and regulatory reporting. Targets pharmaceutical and biotechnology sponsors needing rigorous trial data handling.
• Clinical Operations Full-service clinical trial operations including project management, monitoring and site management, patient recruitment, and patient retention and site engagement. Aimed at sponsors running clinical trials who need operational execution support.
• Regulatory Affairs Regulatory strategy, consulting, marketing applications, Chemistry Manufacturing and Controls (CMC), agency meetings, regulatory publishing, and medical devices/IVDs support. Supports sponsors across FDA interactions and global regulatory submissions.
• Medical Affairs Clinical trial safety, data monitoring committees, and medical monitoring services to support patient safety management throughout the product lifecycle. Targets sponsors needing ongoing safety oversight during and after trials.
• Strategic Consulting Strategic guidance on adaptive designs, statistical power, and clinical and regulatory milestones across the entire development journey. Sold to sponsors seeking expert input on trial design and program planning.
• Medical/Regulatory Writing Clinical trial document writing, regulatory agency communications, and marketing applications preparation services. Supports sponsors preparing submissions to health authorities.
• Pharmacovigilance Patient safety management and risk reduction services throughout the product lifecycle, including medical information safety services. Sold to sponsors needing ongoing post-trial and post-market safety oversight.
• Quality Assurance & Compliance Quality assurance services ensuring compliance with regulatory requirements throughout clinical development. Targeted at sponsors needing audit-ready quality systems.
• FSP/Resourcing

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Scale indicators1 record

Recent moves7 records

Expansion highlights5 records

Direct peers

• Medpace Holdings: Mid-to-large full-service CRO with comparable therapeutic specialization (oncology, rare disease) and biometrics/biostatistics depth. Closely comparable operating model and target sponsor base to Veristat.
• Premier Research: Specialty mid-sized CRO focused on rare disease, pediatrics, and oncology. Directly comparable therapeutic mix and mid-market sponsor focus.
• Theorem (formerly Chiltern): Mid-sized CRO with comparable therapeutic expertise in oncology and rare disease. Directly comparable in scale and sponsor target profile.
• Worldwide Clinical Trials: Mid-sized full-service CRO with strong therapeutic specialization in neuroscience, rare disease, and complex modalities. Highly comparable in scale, sponsor base, and integration of biometrics with clinical operations.
• Biorasi: Mid-sized CRO with concentration in rare disease, oncology, and advanced therapies. Comparable sponsor profile and therapeutic specialization to Veristat.
• Rho: Mid-sized CRO with strong biometrics, biostatistics, and regulatory affairs capabilities, similar to Instat's original core. Comparable in scale and full-service integration.

Broad incumbents

• Parexel International: Large global CRO with comparable biopharmaceutical services including regulatory, biometrics, and clinical operations across complex therapies and rare diseases.
• Syneos Health: Large biopharmaceutical services organization combining CRO capabilities with commercial services. Overlaps with Veristat on clinical development and regulatory offerings.
• ICON plc: Global full-service CRO formed through the PRA Health Sciences merger, offering overlapping clinical operations, biometrics, and regulatory services across all major geographies.
• IQVIA: Largest global CRO offering the full spectrum of clinical, biometrics, regulatory, and post-approval services. Competes with Veristat on large enterprise RFPs but with materially greater scale.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xtwitter.com/VeristatCRO
• YouTubeyoutube.com/@veristat
• Facebookfacebook.com/VeristatCRO
• LinkedInlinkedin.com/company/veristat-llc

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Instat Clinical Research