Cyntegrity

What Cyntegrity does

Cyntegrity is a privately held Frankfurt-based software company that provides an AI-augmented Risk-Based Quality Management (RBQM) platform, branded as MyRBQM Portal, for clinical trial sponsors and contract research organizations (CROs). The platform unifies protocol risk assessment, KRIs, QTLs, central monitoring, predictive signals, medical monitoring, and data quality oversight into a single traceable evidence chain aligned with ICH E6(R3) and E8(R1) expectations, and is deployed on Microsoft Azure cloud infrastructure with Microsoft Healthcare AI Certification, ISO 27001:2022, SOC 2 Type II, ISO 9001:2015, 21 CFR Part 11, and GAMP 5 compliance. Modular capabilities include Central Monitoring Dashboard, Predictive Risk Signals, Data Quality Oversight, Medical Monitoring, Protocol Intelligence, and Risk Management (RACT), supported by API, EDC, and data-lake integration accelerators connecting to Rave, Veeva Vault, InForm, Castor EDC, and Azure/AWS/GCP/Snowflake. The company was founded in 2013/2014 and reports 51-100 employees operating across 12+ countries, with a US subsidiary in San Leandro, an EU R&D base at Frankfurt Innovation Center (FIZ), and a Scientific Advisory Board that includes a former Global Head of Clinical Quality at Roche.

Cyntegrity generates revenue primarily through annual enterprise SaaS subscriptions to the MyRBQM Portal licensed to pharma, biotech, and CRO customers, supplemented by MyRBQM Academy training and certification fees (White/Green/Black Belt, AI Essentials) and expert services for implementation, change management, and clinical due diligence. Pricing is quote-based and modular, reflecting portfolio size, number of studies, and selected capabilities. Go-to-market combines direct enterprise field sales (with EMEA and Americas contact centers) with channel routes through Microsoft Azure Marketplace, strategic consulting partners (PwC, Halloran, ADAMAS), academic and technology partners (Fraunhofer, Mannheim Technical University, MongoDB), and a CRO partnership network (Ergomed, Alimentiv, Tech Observer, Forschungsdock). Named customers include Bristol Myers Squibb, Roche, Biomarin, Bayer, CSL, Orion Pharma, Merz, Vericel, Ardelyx, and multiple CROs; the company cites 500+ organizations trusting its solutions and methods validated across 685+ trials. The company appears to be founder-led and bootstrapped, with no disclosed venture or private equity funding rounds in the source material.

Name

Cyntegrity

Legal name

Cyntegrity Germany GmbH

Website

https://cyntegrity.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

51–100 employees

Short description

Cyntegrity provides MyRBQM Portal, an AI-augmented Risk-Based Quality Management software platform that helps clinical trial sponsors, biotechs, and CROs deliver traceable, ICH E6(R3)-aligned oversight and inspection-ready evidence.

Ownership category

akta.pro rank

Product category

Clinical Trial Risk-Based Quality Management Software

NAICS

Other Scientific and Technical Consulting Services (54169), Computer Systems Design and Related Services (54151)

SIC

Services-Prepackaged Software (7372)

akta.pro primary industry

Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)

akta.pro secondary industries

Pharmacovigilance & Drug Safety Software (HLAGAJAK), Vertical/Industry-Specific LMS (e.g., Healthcare, Safety, Aviation, Government) (EDAFAAAM), Compliance, Safety & Regulatory eLearning Content (EDAGAEAF)

Keywords

• Risk-based quality management
• Clinical trial oversight
• RBQM software platform
• Clinical trial analytics
• Risk assessment software

Headquarters

HQ city

Frankfurt

HQ country

Germany

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

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

Revenue model

1. MyRBQM Portal SaaS Subscription: Annual SaaS subscription for access to the MyRBQM Portal platform including RBQM modules (Risk Management, Central Monitoring, Predictive Signals, Protocol Intelligence, Medical Monitoring, Data Quality Oversight). Modular, integration-ready platform licensed to sponsors and CROs.
2. MyRBQM Academy Training & Certification: Revenue from RBQM training courses including White Belt, Green Belt, and AI Essentials certification programs. Delivered via Open edX platform and Edudip webinar software.
3. Expert Services & Implementation: Functional service provision including expert implementation, change-management support, and clinical due diligence services aligned with ICH expectations.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels8 records

Core offering

Cyntegrity develops and licenses the MyRBQM Portal, a modular AI-augmented SaaS platform that enables clinical trial sponsors, biotech companies, and Contract Research Organizations (CROs) to convert protocol risk assessment into traceable, proportionate, inspection-ready oversight. The platform combines predictive risk signals, central monitoring dashboards, data quality oversight, medical monitoring, protocol intelligence, and an AI-augmented RACT workspace, with related revenue from training/certification (MyRBQM Academy) and professional/clinical due diligence services.

Product overview

Cyntegrity offers a modular AI-augmented RBQM platform plus services architecture centered on the MyRBQM Portal. The core platform provides centralized oversight connecting protocol risk to traceable oversight decisions, featuring modular key capabilities including Central Monitoring Dashboard, Predictive Risk Signals, Data Quality Oversight, Medical Monitoring, Protocol Intelligence, and Risk Management. Integration accelerators (API Integration, EDC Connector, Data Lake Bridge) enable connectivity with external clinical systems. The ecosystem is complemented by MyRBQM Academy offering role-based RBQM training and certification (White Belt, Green Belt, AI Essentials), a Clinical Monitoring Cost Savings Calculator tool, and Clinical Due Diligence services. The company positions itself as a pure-play RBQM software provider focused exclusively on risk-based quality management for clinical trials under ICH E6(R3) and E8(R1) guidelines.

Differentiator

Problem solved

Functional benefit

Brands

• MyRBQM: AI-augmented Risk-Based Quality Management platform providing oversight tools for clinical trials, including risk management, central monitoring, predictive signals, and protocol intelligence.
• MyRBQM Academy

Products and services

• MyRBQM Portal Modular AI-augmented RBQM SaaS platform providing centralized, traceable clinical trial oversight for sponsors, biotechs, and CROs. Connects protocol risk assessment, KRIs/QTLs, central monitoring, predictive signals, medical monitoring, and data quality oversight with role-based access control, AI workflows, and EDC/data lake integrations, aligned with ICH E6(R3)/E8(R1) and 21 CFR Part 11.
• MyRBQM Academy Industry reference standard for RBQM training and certification delivered via Open edX, offering role-based capability pathways (White Belt, Green Belt, Black Belt) and AI Essentials training for clinical trial professionals.
• RBQM Essentials – White Belt Approximately 80-minute self-paced foundation course providing shared RBQM vocabulary and aligned decision logic, with certification issued upon completion; targeted at professionals entering RBQM.
• Applied RBQM – Green Belt Applied RBQM skills course for study leads and operational teams using real clinical data, covering protocol design, risk evaluation, and data-driven oversight practice; certification issued on completion.
• AI in Clinical Trials Training Introductory training course on applying AI within GCP-compliant workflows for protocol design, monitoring, and documentation, with defined controls, validation, and human oversight; aligned with ICH E6(R3).
• Clinical Monitoring Cost Savings Calculator Interactive assessment tool modeling potential monitoring cost savings from transitioning from full SDV to risk-based quality management, using study-level inputs including site count, enrollment period, visit frequency, and risk stratification.
• Clinical Due Diligence Expert service assessing execution risk, data reliability, and inspection readiness before asset licensing or acquisition; evaluates data completeness vs. credibility, visibility gaps, and decision traceability, with a Clinical Due Diligence Scoring Checklist.

Quantifiable outcome

• Up to 60% increase in signal visibility
• +10 more outcomes

Named customers13 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

Yes

API docs

API detail

Core technology

AI maturity

App detail

Integration13 records

AI capability12 records

Feature7 records

Partnerships

14 partnerships are on record, tiered strategic, core technology, core, academic, channel and technology.

• PwCstrategicStrategic or Co-development Partner · 1 January 2021Strategic partnership for aligning risk-based oversight with global compliance expectations including ICH E6(R3) inspection readiness. PwC leverages Cyntegrity's RBQM platform for regulatory-aligned quality management and inspection readiness consulting.
• Microsoftcore technologyTechnology or IntegrationHealthcare AI-certified MyRBQM deployed on Azure cloud infrastructure. Microsoft commissioned independent audit of Cyntegrity's AI practices, resulting in Azure Marketplace listing and co-marketing through Microsoft Story.
• Halloran Consulting GroupstrategicImplementation/ SI/ Consulting PartnerHalloran helps MedTech and biotech organizations operationalize RBQM consistently and efficiently, leveraging Cyntegrity's platform for implementation and change management support.
• ADAMAS ConsultingcoreStrategic or Co-development PartnerStrategic collaboration blending predictive analytics with expert QA to sharpen inspection confidence in complex trials. Joint case study on Phase III oncology demonstrating targeted risk-based QA using AI-augmented RBQM analytics.
• NovartisacademicStrategic or Co-development PartnerProvided anonymized study data to support development of practical framework for setting and managing Quality Tolerance Limits (QTLs). Academic submission under peer review with publication expected Q1 2026.
• Mannheim Technical UniversityacademicStrategic or Co-development PartnerJoint validation lab for GxP-ready large-language models ensuring AI outputs remain clinically interpretable, explainable, and inspector-defensible.
• Fraunhofer-GesellschaftacademicStrategic or Co-development PartnerAI-TRIAL initiative advancing clinical-trial AI with independent method validation under LOEWE funding (HA-Projekt-Nr.: 2004/25-112). €1.2M LOEWE-funded projects advancing AI-driven RBQM algorithms.
• Ergomed Clinical ResearchchannelChannel Partner/ Reseller/ DistributorCRO partnership for delivering risk-based quality management services. Ergomed's RBQM approach represents future of clinical trial management.
• Tech ObserverchannelChannel Partner/ Reseller/ DistributorCRO partnership delivering end-to-end services driving success of clinical trials at every phase with RBQM integration.
• AlimentivchannelChannel Partner/ Reseller/ DistributorCRO collaboration for site management and risk-based monitoring services with long-standing local knowledge and expertise partnerships.
• Forschungsdock CROchannelChannel Partner/ Reseller/ DistributorContract research organization based in Hamburg providing risk-based quality management services.
• MongoDBtechnologyTechnology or IntegrationMongoDB Atlas provides flexible data workflows powering AI-augmented oversight. MongoDB case study documents Cyntegrity's clinical data architecture.
• University Medicine EssenacademicStrategic or Co-development PartnerClinical-science expertise supporting AI that is safe, fair, and clinically interpretable for responsible AI in clinical trials.
• FIZ Frankfurt Innovation CenterstrategicStrategic or Co-development PartnerEU R&D base inside Germany's largest biotech campus supporting continuous RBQM product advancement and rapid prototyping.

Scale indicators5 records

Recent moves9 records

Expansion highlights6 records

Broad incumbents

• Oracle Clinical One: Oracle's Clinical One platform unifies EDC, CTMS, and risk-based monitoring under one vendor, positioning Oracle as a broad incumbent alternative to Cyntegrity's standalone RBQM approach for large sponsors.
• IQVIA: IQVIA offers risk-based monitoring, centralized monitoring, and AI-driven trial analytics as part of its full-service CRO and technology portfolio, competing with Cyntegrity for sponsor RBQM technology spend across enterprise pharma.
• Clario: Clario (formerly ERT/Bioclinica) provides endpoint technology and trial oversight solutions, including RBQM-adjacent analytics, positioning it as a broad incumbent that overlaps with Cyntegrity on centralized monitoring and risk oversight.
• Medidata (Dassault Systèmes): Medidata's Rave platform is the dominant EDC in enterprise pharma and increasingly bundles RBQM capabilities, making it a broad incumbent that competes with Cyntegrity for enterprise RBQM budget within existing EDC relationships.
• Veeva Systems: Veeva Vault CTMS and the broader Veeva Clinical Suite offer risk-based monitoring and trial oversight modules as part of an enterprise clinical platform, competing with Cyntegrity especially in Top-10 pharma accounts.

Direct peers

• Saama Technologies: Saama offers AI-driven clinical trial analytics and risk-based monitoring solutions, competing head-on with Cyntegrity in applying machine learning to operational and clinical risk signals across pharma portfolios.
• CluePoints: CluePoints provides a centralized statistical monitoring and RBQM platform for clinical trials, directly competing with MyRBQM on risk-based monitoring, KRIs/QTLs, and data quality oversight for sponsors and CROs.
• eClinical Solutions (Elluminate): eClinical Solutions' Elluminate Clinical Data Cloud delivers centralized data review, analytics, and risk-based monitoring workflows for clinical trials, directly comparable to Cyntegrity's central monitoring and data quality oversight modules.

Emerging players

• Bioforum: Bioforum is a data-focused CRO that builds RBQM and centralized monitoring services around third-party platforms, overlapping with Cyntegrity on CRO-side delivery and clinical due diligence use cases.
• CASTOR: Castor is an emerging eClinical platform that integrates with RBQM tools and increasingly competes for mid-size sponsor and CRO budgets where Cyntegrity's agile RBQM positioning is strongest.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat7 records

Key risks6 records

Key highlights7 records

Customer concentration

• YouTubeyoutube.com/c/MyRBQMAcademyCyntegrityEDU
• LinkedInlinkedin.com/company/cyntegrity-germany-gmbh

Compliance8 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles16 records

Funding overview

Funding rounds1 record

Investors1 record

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 Cyntegrity