FACT
FACT is a nonprofit accreditation organization that develops peer-reviewed standards and inspects cellular therapy programs, cord blood banks, and immune effector cell facilities worldwide, serving as the voluntary accreditation arm of ASTCT and ISCT.
- Company typePrivate
- Founded1995
- HeadquartersOmaha, United States
- Headcount11–50
- GTM typeB2B
- OfferingServices
What FACT does
FACT (Foundation for the Accreditation of Cellular Therapy) is a Nebraska-incorporated nonprofit founded in 1995–1996 that operates as the voluntary inspection and accreditation arm of two major professional societies: ASTCT (American Society for Transplantation and Cellular Therapy) and ISCT (International Society for Cell & Gene Therapy). It serves cellular therapy clinical programs, cord blood banks, collection facilities, processing facilities, and immune effector cell programs worldwide by issuing peer-developed consensus standards and conducting voluntary accreditation inspections. Its core product surface consists of the FACT Accreditation Portal (a secure OAuth2-authenticated platform managing application submission, compliance documentation, inspection scheduling, and renewal workflows), the FACT Standards (Hematopoietic Cellular Therapy, Immune Effector Cells, Cord Blood Banking, and Common Standards editions), the Learning and Development Academy (webinars, boot camps, Quality Management Series, and inspector development modules), and FACT Consulting Services (a wholly-owned nonprofit subsidiary providing pre-accreditation consulting).
FACT monetizes accreditation through annual subscription-style accreditation fees scaled to scope of services and patient/product volume, a one-time initial registration fee, fee-for-service consulting engagements, and transactional sales of educational content ($100/webinar, $650/boot camp, $340 for 4-part bundles) and printed or digital standards manuals. Accreditation is granted for 3-year cycles with renewal beginning around the second anniversary, and the typical accreditation process takes one year or less. The organization is supported by a global volunteer inspector network, a 17-member Board with directors appointed by ASTCT and ISCT, and approximately 30–40 staff based at its Omaha, Nebraska headquarters. FACT co-publishes standards internationally through the Joint Accreditation Committee of ISCT and EBMT (JACIE) and maintains operational partnerships with WMDA, CIBMTR, and other transplant/cell therapy organizations.
Revenue is not publicly disclosed and FACT does not raise external equity; funding derives from accreditation fees, educational sales, consulting revenue, and likely dues or grants from its member societies. There are no patents, no M&A activity, no funding rounds, and no AI/ML capabilities disclosed in the source material.
FACT firmographics
Firmographics- Name
- FACT
- Legal name
- The Foundation for the Accreditation of Cellular Therapy
- Website
- https://factglobal.org
- Company type
- Private
- Founded year
- 1995
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- FACT is a nonprofit accreditation organization that develops peer-reviewed standards and inspects cellular therapy programs, cord blood banks, and immune effector cell facilities worldwide, serving as the voluntary accreditation arm of ASTCT and ISCT.
- Ownership category
- akta.pro rank
FACT industry classification
Industry- Product category
- Healthcare Accreditation Services
- NAICS
- Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Testing Laboratories and Services (541380)
- SIC
- Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731)
- akta.pro primary industry
- Accreditation Evaluation, Peer Review & Site-Visit Organizations (EDADACAI)
- akta.pro secondary industries
- Institutional & Programmatic Accreditation Audits (EDADAGAA), Laboratory Quality Systems, Accreditation & Proficiency Testing Programs (HLAJAIAM)
Keywords
Where FACT is headquartered
LocationHeadquarters
- HQ city
- Omaha
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
FACT business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Operations, Technology or R&D, Marketing or Sales, Others
Revenue model
- Accreditation Fees: Annual accreditation fees based on the scope of services and volume of patients treated or cellular therapy products provided by the organization. Fees are customized to individual accreditation and provide a predictable annual payment schedule.
- Initial Registration Fee: One-time registration fee required when applying for initial accreditation
- Educational Content Sales: Revenue from educational webinars, boot camps, and training materials. Webinars typically priced at $100, boot camps at $650, with free content for inspectors and committee members
- FACT Consulting Services: Customizable consulting solutions through a non-profit subsidiary to help organizations prepare for accreditation
- Standards and Manuals Sales: Sale of FACT Standards and Accreditation Manuals in digital or printed form
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Annual | Annual Accreditation Fees |
| One time/ perpetual license | Multi-year contract | Initial Registration Fee |
| Subscription | Pay-as-you-go | On-Demand Webinars |
| Subscription | Pay-as-you-go | Quality Boot Camps |
| Subscription | Annual | Inspector Annual Learning Bundle |
| Subscription | Pay-as-you-go | QM Series Bundles |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels6 records
FACT product offering
Product offeringCore offering
FACT develops peer-reviewed consensus-based accreditation Standards and provides voluntary accreditation services for cellular therapy clinical programs, cord blood banks, collection facilities, and processing facilities worldwide. The accreditation process involves eligibility application, compliance documentation submission, on-site inspections by volunteer inspectors, and ongoing annual compliance, all managed through the FACT Accreditation Portal. FACT also offers educational content, consulting services for accreditation preparation, and standards publications to support organizations pursuing and maintaining accreditation.
Product overview
FACT (Foundation for the Accreditation of Cellular Therapy) operates as a unified platform with multiple interconnected products focused on cellular therapy accreditation and quality assurance. The core offering includes the FACT Accreditation Portal for managing accreditation workflows, the Learning and Development Academy for education and training, and FACT Standards (including HCT, IEC, Cord Blood, and Common Standards editions). Additional offerings include FACT Consulting Services for accreditation preparation support, the FACT Inspector Handbook for inspector guidance, and Community IEC Standards for expanding access to cell therapies in community settings. These products work together to support the complete cellular therapy journey from standards development through accreditation and ongoing quality improvement.
Differentiator
Problem solved
Functional benefit
Brands
- FACT Consulting Services: Nonprofit subsidiary providing customizable consulting solutions to help organizations prepare for FACT accreditation.
- FACT Learning and Development Academy
Products and services
- FACT Accreditation Voluntary peer-reviewed accreditation services for cellular therapy programs, cord blood banks, collection facilities, processing facilities, and immune effector cell programs. The process involves eligibility application, compliance documentation submission, on-site inspection by volunteer inspectors, and ongoing annual compliance, with accreditation valid for 3 years.
- FACT Standards Peer-developed consensus standards for cellular therapy covering Hematopoietic Cellular Therapy (HCT), Immune Effector Cells (IEC), Cord Blood Banking, and Common Standards, available in digital or printed form.
- Learning and Development Academy An educational platform providing live, online, and on-demand educational opportunities including the Quality Management Series, on-demand recordings, registration for live events, inspector development modules, webinars (typically $100), and Quality Boot Camps ($650).
- FACT Consulting Services A non-profit subsidiary of FACT providing customizable consulting solutions to help organizations prepare for FACT accreditation, covering quality management, standards compliance, and readiness assessment.
- FACT Inspector Handbook (5th Edition) A comprehensive online handbook providing guidance for FACT inspectors covering all aspects of the inspection process from preparation through post-inspection activities.
- FACT Community IEC Standards Standards specifically designed for Immune Effector Cells in community clinical settings, aimed at bringing cell therapies closer to patients in community oncology practices.
Quantifiable outcome
- Accreditation valid for 3 years with renewal process
- +1 more outcomes
Companies that use FACT
Customer profileNamed customers5 records
Segments5 records
Ideal customer profiles4 records
FACT technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
FACT partnerships and signals
Strategic signalPartnerships
Five partnerships are on record, tiered core and flagship.
- ISCT (International Society for Cell & Gene Therapy)coreISCT is a global association driving the translation of scientific research to deliver innovative cellular therapies to patients. Since 1992, ISCT has been the leading global forum for developing and supporting innovative cellular therapies. FACT is the voluntary inspection and accreditation arm of ISCT, with ISCT members sharing a vision to translate cell and gene therapies into safe and effective therapies to improve patients' lives worldwide.
- ASTCT (American Society for Transplantation and Cellular Therapy)coreASTCT is an international professional association that promotes the advancement of the blood and marrow transplantation field. ASTCT members are both in clinical practice and in research. FACT is the voluntary inspection and accreditation arm of ASTCT, with ASTCT striving to be the leading organization promoting research, education, and clinical practice in cellular therapy.
- EBMT (European Society for Blood and Marrow Transplantation)flagshipFACT co-publishes Standards with the Joint Assurance Committee of ISCT and EBMT (JACIE). This international collaboration promotes harmonized requirements that promote patient access and product approvals across international borders.
- WMDA (World Marrow Donor Association)coreFACT accreditation includes inspection standards for cord blood banks, with some banks being members of WMDA (NetCord) for international cord blood exchange and standards harmonization.
- CIBMTR (Center for International Blood and Marrow Transplant Research)coreFACT partners with CIBMTR for data audit and management services. The FACT-CIBMTR Data Audit Committee reviews implementation, adequacy, and effectiveness of corrective action plans. CIBMTR provides training materials, reference manuals, and data submission systems used by accredited programs.
Scale indicators4 records
Recent moves1 record
Expansion highlights5 records
FACT competitors and assessment
Company assessmentDirect peers
- JACIE (Joint Accreditation Committee ISCT-EBMT): JACIE is the European cellular therapy accreditation body co-publishing standards with FACT under the ISCT-EBMT Joint Assurance Committee. It is the closest direct peer, operating the same accreditation model in a complementary geography with overlapping standards.
- AABB (Association for the Advancement of Blood & Biotherapies): AABB accredits blood banks, cellular therapy, and biotherapy programs with overlapping scope in cord blood and cell therapy. It is a direct peer in cellular therapy accreditation with comparable consensus-based standards and on-site inspection workflows.
Broad incumbents
- College of American Pathologists (CAP): CAP is a leading laboratory accreditation body with broad reach across clinical labs, including cellular therapy processing facilities. It is a broader incumbent that competes with FACT for laboratory accreditation mandates in processing facilities and similar settings.
- The Joint Commission: The Joint Commission is the dominant US healthcare facility accreditation body. While it does not specialize in cellular therapy, it competes for broader hospital accreditation scope and could expand into specialty cellular therapy accreditation in the future.
- CLIA-certified laboratory accreditation bodies: Multiple CLIA-equivalent laboratory accreditation providers cover processing facilities that FACT also accredits. They are broad incumbents competing for laboratory compliance mandates that overlap with FACT processing facility accreditation.
Others
- NMDP (National Marrow Donor Program) / Be The Match: NMDP operates the US marrow donor registry and works closely with transplant and cellular therapy centers. It is an ecosystem partner rather than direct competitor but influences the operating environment in which FACT-accredited programs operate.
- CIBMTR (Center for International Blood and Marrow Transplant Research): CIBMTR is a data audit and outcomes partner that works with FACT-accredited programs for data submission and audit. It is an ecosystem collaborator rather than competitor but exerts influence on program quality expectations that shape FACT standards.
Regional players
- WMDA (World Marrow Donor Association): WMDA sets international standards for stem cell donor registries and works with FACT on cord blood banking accreditation via the NetCord relationship. It is an adjacent standards organization with international scope and partial overlap in cord blood oversight.
- Foundation for the Accreditation of Cellular Therapy - Australia / Asia equivalents: Regional accreditation bodies modeled after or aligned with FACT operate in parts of Asia-Pacific. These regional players compete in their geographies while typically aligning with FACT-JACIE standards, creating partial direct competition internationally.
Emerging players
- ASHI (American Society for Histocompatibility and Immunogenetics): ASHI accredits histocompatibility laboratories that often interact with transplant and cellular therapy programs. It is an emerging adjacent player in the transplant quality ecosystem with overlapping customer base but narrower scope than FACT.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
FACT social profiles
Digital presenceFACT financial estimates
Financial estimateRevenue estimate
Valuation estimate
FACT leadership team
Management profileNumber of profiles
Profiles13 records
FACT subsidiaries and ownership
Company hierarchySubsidiaries1 record
FACT funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
FACT 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 FACT
What does FACT do?
FACT develops peer-reviewed consensus-based accreditation Standards and provides voluntary accreditation services for cellular therapy clinical programs, cord blood banks, collection facilities, and processing facilities worldwide. The accreditation process involves eligibility application, compliance documentation submission, on-site inspections by volunteer inspectors, and ongoing annual compliance, all managed through the FACT Accreditation Portal. FACT also offers educational content, consulting services for accreditation preparation, and standards publications to support organizations pursuing and maintaining accreditation.
Is FACT a public or private company?
FACT is a private company. It is classified as nonprofit foundation owned and is currently operating.
When was FACT founded?
FACT was founded in 1995. It employs 11 to 50 people.
Where is FACT based?
FACT is headquartered in Omaha, United States, in the North America region.
How does FACT make money?
Five revenue lines are on record. Accreditation Fees are the primary driver. The others are initial Registration Fee, educational Content Sales, FACT Consulting Services and standards and Manuals Sales.
Who are FACT's main competitors?
Direct peers on record are JACIE (Joint Accreditation Committee ISCT-EBMT) and AABB (Association for the Advancement of Blood & Biotherapies). Broad incumbents are College of American Pathologists (CAP), The Joint Commission and CLIA-certified laboratory accreditation bodies. Others are NMDP (National Marrow Donor Program) / Be The Match and CIBMTR (Center for International Blood and Marrow Transplant Research). Regional players are WMDA (World Marrow Donor Association) and Foundation for the Accreditation of Cellular Therapy - Australia / Asia equivalents. ASHI (American Society for Histocompatibility and Immunogenetics) is listed as an emerging player.
Does FACT have an API?
No public API is recorded for FACT.
What industry is FACT in?
FACT's product category is Healthcare Accreditation Services. Its primary akta.pro industry code is EDADACAI, Accreditation Evaluation, Peer Review & Site-Visit Organizations, with a secondary code of EDADAGAA, Institutional & Programmatic Accreditation Audits. Its NAICS code is 621511 and its SIC code is 8071.