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Pharmacovigilance
Risk Management
Technology & Operations
Data & Analytics
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26-75 Employee | 1 Contact
Year Founded

2013

Headquarters

, Frankfurt am Main, Frankfurt am Main, Hessen, DEU

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Cyntegrity

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Cyntegrity is a leading provider of AI-enabled Risk-Based Quality Management (RBQM) solutions purpose-built for the life sciences industry. Our mission is to empower sponsors, CROs, and regulators with predictive insights, operational transparency, and intelligent decision support across the clinical trial lifecycle. At the core of our offering is the MyRBQM® Portal, a secure, cloud-based platform that integrates data-driven risk assessment, centralized monitoring, and quality oversight into a unified, regulatory-aligned environment. The platform enables compliance with ICH E6(R3) and ICH E8(R1) by operationalizing Quality by Design (QbD) and continuous risk management principles. Key Capabilities: AI-Augmented Risk Assessment: Identify, score, and prioritize study-specific risks using structured templates and contextual machine learning. Centralized Monitoring: Detect safety, protocol, and operational signals using intelligent Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and trend analytics. Protocol Deviation Detection: Uncover underreported or misclassified deviations with AI-supported algorithms and data pattern recognition. Regulatory Compliance: Ensure GxP, 21 CFR Part 11, and GDPR compliance with robust audit trails, role-based access control, and full traceability. Customizable Workflows: Tailor monitoring plans, risk libraries, and review workflows to align with study-specific and organizational requirements. Why Customers Choose Cyntegrity: Regulatory Alignment: Trusted by regulators and top-tier sponsors for our leadership in interpreting and implementing ICH guidelines. Scientific Rigor: Co-developed with global clinical experts, our models are continuously validated with real-world study data. Efficiency & Cost Savings: Reduce SDV, site visits, and rework while enhancing quality oversight and decision-making speed. Innovation at Scale: AI-enhanced modules integrate seamlessly into modern trial ecosystems and eClinical stacks. Client Portfolio: Cyntegrity supports pharmaceutical sponsors, CROs, and research institutions across over 60 countries. Our technology is used in hundreds of clinical trials, ranging from early-phase studies to complex, global Phase III programs.
Cyntegrity is a leading provider of AI-enabled Risk-Based Quality Management (RBQM) solutions purpose-built for the life sciences industry. Our mission is to empower sponsors, CROs, and regulators with predictive insights, operational transparency, and intelligent decision support across the clinical trial lifecycle. At the core of our offering is the MyRBQM® Portal, a secure, cloud-based platform that integrates data-driven risk assessment, centralized monitoring, and quality oversight into a unified, regulatory-aligned environment. The platform enables compliance with ICH E6(R3) and ICH E8(R1) by operationalizing Quality by Design (QbD) and continuous risk management principles. Key Capabilities: AI-Augmented Risk Assessment: Identify, score, and prioritize study-specific risks using structured templates and contextual machine learning. Centralized Monitoring: Detect safety, protocol, and operational signals using intelligent Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and trend analytics. Protocol Deviation Detection: Uncover underreported or misclassified deviations with AI-supported algorithms and data pattern recognition. Regulatory Compliance: Ensure GxP, 21 CFR Part 11, and GDPR compliance with robust audit trails, role-based access control, and full traceability. Customizable Workflows: Tailor monitoring plans, risk libraries, and review workflows to align with study-specific and organizational requirements. Why Customers Choose Cyntegrity: Regulatory Alignment: Trusted by regulators and top-tier sponsors for our leadership in interpreting and implementing ICH guidelines. Scientific Rigor: Co-developed with global clinical experts, our models are continuously validated with real-world study data. Efficiency & Cost Savings: Reduce SDV, site visits, and rework while enhancing quality oversight and decision-making speed. Innovation at Scale: AI-enhanced modules integrate seamlessly into modern trial ecosystems and eClinical stacks. Client Portfolio: Cyntegrity supports pharmaceutical sponsors, CROs, and research institutions across over 60 countries. Our technology is used in hundreds of clinical trials, ranging from early-phase studies to complex, global Phase III programs.
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Headquarters

, Frankfurt am Main, Frankfurt am Main, Hessen, DEU