FACIT Group

What FACIT Group does

FACIT Group is a private non-profit organization headquartered in Ponte Vedra Beach, Florida, operating through two interconnected entities: FACIT.org, which licenses the FACIT Measurement System, and FACITtrans, LLC, which provides translation and linguistic validation services. The FACIT Measurement System is a comprehensive library of over 700 items, 130 pediatric items, and more than 100 validated questionnaires assessing health-related quality of life in chronic illness populations, with cancer-specific modules (FACT-G and disease-specific extensions) and symptom-specific measures. The system is offered in 80+ languages, and FACITtrans has cognitively debriefed over 10,000 patients globally. FACIT.org also manages licensing for third-party COAs, including the C-Path PRO Consortium's measures since 2019.

The underlying technology is a domain-specific content library supported by a proprietary Universal Translation Methodology that produces a single valid translation per language for cross-country comparability, eCOA adaptation and migration services (XML/JSON/CSV), and the FACIT Searchable Item Library with a Build-a-PRO function for custom measure assembly. The translation methodology, first published in 1996, is the de facto standard adopted by NIH PROMIS, Neuro-QOL, NIH Toolbox, and C-Path, and FACITtrans is ISO 9001:2015 and ISO 17100:2015 certified. FACT measures have been included in 26.6% of EMA oncology submissions, with a 66.7% label-claim success rate.

The company monetizes through per-trial/per-measure licensing fees for commercial use by top pharmaceutical companies, professional services fees for translation and linguistic validation on initial use (subsequent uses of the same translation are free of charge to the original sponsor), and managed services for COA licensing administration on behalf of clients. Non-commercial use (academic, investigator-initiated, clinical) is typically fee-waived. The company operates as a sales-led enterprise with direct website registration, high-touch staff follow-up, and a relationship-driven conference presence at ISOQOL, ISPOR, ATA, and PHO. The organization has 11-50 employees and no external funding, with revenue not publicly disclosed.

Name

FACIT Group

Legal name

FACIT Group

Website

https://facit.org

Company type

Private

Founded year

1988

Operating status

Operating

Headcount range

11–50 employees

Short description

FACIT Group is a non-profit organization that licenses the FACIT Measurement System (100+ validated health-related quality-of-life questionnaires in 80+ languages) and provides translation and linguistic validation services to pharmaceutical companies for multinational clinical trials and regulatory label claims.

Ownership category

akta.pro rank

Product category

Clinical Outcome Assessment Services

NAICS

Scientific Research and Development Services (5417)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Medical Writing & Regulatory Submission Support CROs (HLAGAAAG)

akta.pro secondary industry

Real-World Evidence (RWE), HEOR & Epidemiology CROs (HLAGAAAK)

Keywords

• Clinical outcome assessments
• Patient-reported outcomes
• Linguistic validation services
• Health-related quality of life
• COA translation services

Headquarters

HQ city

Ponte Vedra Beach

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

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

Revenue model

1. COA Licensing Fees: Licensing fees are assessed on a per trial/per measure basis for commercial use. There is no fee for use of the English version, but a license should be obtained. Non-commercial use is assessed case-by-case with fees typically waived for investigator-initiated research, students, or clinical use.
2. Translation and Linguistic Validation Services: FACITtrans provides translation services of unsurpassed quality to the international clinical research community. After an initial translation fee for pharma-sponsored trials, subsequent uses of said translation(s) are free of charge to the sponsor.
3. COA Management and Licensing Services: FACIT.org manages licensing for FACIT measures, C-Path COA measures, and other questionnaires on behalf of clients. Provides distribution, infrastructure support, and Q&A support for measure implementation.

Pricing tiers

Go-to-market motion3 records

Distribution channels2 records

Marketing channels4 records

Core offering

FACIT Group manages the licensing and distribution of the FACIT Measurement System—more than 100 validated questionnaires and 700+ items assessing health-related quality of life across chronic illnesses—and provides professional translation and linguistic validation services for these Clinical Outcome Assessments (COAs) in 80+ languages. Through its FACIT.org and FACITtrans divisions, the organization serves pharmaceutical clinical trials, academic researchers, and other COA developers (including the NIH PROMIS initiative and the Critical Path Institute) with measure licensing, eCOA adaptation, and custom measure creation via the Build-a-PRO function.

Product overview

FACIT Group is a health outcomes research organization comprised of two inter-related divisions: FACIT.org (licensing entity) and FACITtrans (translation services). The core product is the FACIT Measurement System, a collection of over 700 items, 130 pediatric items, and 100 validated measures assessing health-related quality of life for chronic illness. The system includes the FACIT Searchable Item Library with a Build-a-PRO function for custom measure creation. FACIT.org manages licensing for FACIT measures and other COAs including PROMIS and C-Path measures. FACITtrans provides translation and linguistic validation services, eCOA adaptation and migration, with ISO 9001:2015 and ISO 17100:2015 certifications. The portfolio spans cancer-specific measures (FACT-G as core), treatment-specific measures, symptom-specific measures, palliative care, pediatric measures, and utility indexes (FACT-8D).

Differentiator

Problem solved

Functional benefit

Products and services

• FACIT Measurement System
• FACIT Searchable Item Library
• Translation and Linguistic Validation Services
• eCOA Adaptation and Migration Services
• COA Management and Licensing Services
• FACT-G (Functional Assessment of Cancer Therapy - General)

Quantifiable outcome

• FACT measures included in 12 (26.6%) of EMA oncology submissions and led to labeling for 8 (38.1%) of indications reviewed
• +2 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Nine partnerships are on record, tiered core and minor.

• Northwestern University (Dr. David Cella's Research Program)coreStrategic or Co-development PartnerFACIT Group maintains a strong ongoing collaboration with Dr. Cella's research program at Northwestern University, the largest academically-based outcomes research group in the world. This partnership provides scientific direction and academic grounding for FACIT's measurement system development and validation.
• Critical Path Institute (C-Path)coreStrategic or Co-development PartnerSince 2019, FACIT.org manages licensing for C-Path PRO Consortium's patient-reported outcome measures. FACIT Group operates the www.c-pathcoas.org website on behalf of CPI and provides comprehensive COA management services.
• National Institutes of Health (NIH) - PROMIScoreStrategic or Co-development PartnerFACITtrans serves as the principal translation resource for NIH PROMIS (Patient Reported Outcomes Measurement Information System) item banks. Dr. Cella was Principal Investigator of the PROMIS Statistical Coordinating Center. FACIT items are used in PROMIS and can be scored on a national metric.
• NIH - NeuroQOLcoreStrategic or Co-development PartnerFACITtrans serves as the principal translation resource for Neuro-QOL (Quality of Life in Neurological Disorders) item banking project, a federally-funded initiative specific to neurological conditions.
• NIH - ToolboxcoreStrategic or Co-development PartnerFACITtrans serves as the principal translation resource for NIH Toolbox assessment, providing translations for this comprehensive assessment battery.
• ISOQOL (International Society for Quality of Life Research)coreStrategic or Co-development PartnerMember for over 20 years and financial sponsor. FACIT leadership has held Co-Chair positions on the Translation and Cultural Adaptation SIG. Team members present regularly at ISOQOL conferences and contribute to the field's scientific literature.
• ISPOR (International Society for Pharmacoeconomics and Outcomes Research)coreStrategic or Co-development PartnerMember for over 20 years. FACITtrans is a founding member of the ISPOR Task Force for Translation and Cultural Adaptation which established the seminal 'Principles of Good Practice for Translation and Cultural Adaptation Process for PRO Measures' (Wild, 2005), now industry standard.
• PROMIS Health Organization (PHO)coreStrategic or Co-development PartnerFACIT Group proudly supports the PHO, whose mission is to improve health outcomes by developing and encouraging application of PROMIS in research and clinical practice. Contributes financially to PHO Annual Conferences and regularly presents research.
• American Translators Association (ATA)minorStrategic or Co-development PartnerMember for over 20 years. Team regularly presents at ATA conferences, publishes articles, presents posters, and attends meetings.

Scale indicators6 records

Recent moves10 records

Expansion highlights7 records

Emerging players

• Kayentis: Kayentis is a specialist eCOA and patient-centric clinical trial technology provider serving pharma and CROs. It overlaps with FACITtrans on eCOA migration and multilingual deployment, but focuses more on technology platform than on translation methodology.

Broad incumbents

• ICON plc: ICON is a top global CRO with dedicated COA, translation, and linguistic validation capabilities (including the former Mapi Language Services). It directly competes with FACITtrans for multilingual COA translation contracts in clinical trials.
• IQVIA: IQVIA is the world's largest CRO with comprehensive clinical research and translation services. Its linguistic validation and COA translation capabilities compete with FACITtrans at the high end of the pharma market, particularly for full-service trial engagements.
• Lionbridge Life Sciences: Lionbridge is a major translation services provider with a dedicated life sciences practice offering COA translation, linguistic validation, and eCOA migration. It competes with FACITtrans across large pharma accounts and clinical trial translation engagements.
• Parexel International: Parexel is a major global CRO with full-service clinical research capabilities, including COA translation and linguistic validation services. Its scale and end-to-end trial execution capability make it a competitor for FACIT's pharmaceutical clients, particularly for full-service contracts.
• Clario (formerly ERT/Bioclinica): Clario is a large technology provider of eCOA solutions and clinical trial endpoint services to pharma. It competes with FACITtrans on eCOA adaptation and migration services, but as part of a much broader portfolio spanning imaging, wearables, and respiratory solutions.
• TransPerfect Life Sciences: TransPerfect is one of the largest language service providers globally, with a dedicated life sciences division offering COA translation and linguistic validation. It competes with FACITtrans on volumes and language breadth, though with less PRO-specific methodology.
• Signant Health (formerly CRF Health + Bracket): Signant Health is a leading eCOA and clinical technology provider offering electronic patient-reported outcome solutions for clinical trials. It overlaps with FACIT on eCOA migration and screenshot proofing services as part of a broader rating scale and rater training portfolio.

Direct peers

• Critical Path Institute (C-Path): C-Path is a non-profit that develops and standardizes clinical outcome assessments through consortia, and is a partner of FACIT Group. It operates overlapping COA development and licensing activities, making it a direct functional peer in PRO consortium management.
• Mapi Research Trust: Mapi Research Trust is a non-profit that manages distribution, licensing, and linguistic validation of patient-reported outcome measures worldwide. It is the most directly comparable peer to FACIT.org, operating an analogous COA licensing and translation model.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/facitgroup

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles8 records

Subsidiaries2 records

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 FACIT Group