The Security and Responsible AI You Need to Power Global Clinical Trials
Your innovations must be as trustworthy as they are transformative. That’s why every AI capability is built on secure data practices, explainable models, and accountable governance.
Ethical, human-centered intelligence helps you move faster—while protecting patients, data, and regulatory integrity.
INDUSTRY RECOGNITION
Everest Group 2026 Innovation Watch Report
Everest Group evaluated 18 providers and named Medidata the highest placed “Luminary” in their assessment—a ranking driven by our market performance, robust partnerships, and the maturity of our AI solutions.
INDUSTRY RECOGNITION
Gartner® Hype Cycle™ report:
Gartner’s 2025 Hype Cycle highlights the Digital Protocol as a key shift from document-based trials to data-first R&D.
Trusted
Maturity
25+ Years in Clinical Development
For more than 25 years, Medidata has supported clinical development at global scale, serving 2,300+ customers and contributing to more than half of approved drugs and medical devices worldwide.
We also bring more than a decade of applied AI innovation, positioning us as a mature, trusted, and transparent partner for safeguarding sensitive data and responsibly building advanced solutions in clinical trials.
That scale matters. Your trials run on infrastructure that's been rigorously validated by third-party oversight. Medidata was the first life sciences organization to complete the biannual SOC 2+ Type II audit and the first U.S. life sciences company to achieve ISO 27701 certification for Privacy Information Management—protecting your data, patients, and regulatory standing.
Your advantage: enterprise-grade security, transparent governance, and clinically grounded AI—so you accelerate progress without compromising trust.
Responsible
Ethical
Ethical AI. Operationalized.
Your trials demand technology grounded in ethics and global standards. Medidata’s commitment to ICH-GCP principles ensures that every AI capability aligns with the regulatory and scientific rigor your programs require.
Our AI moral compass translates responsible AI principles—grounded in the NIST AI Risk Management Framework—into everyday practice. This means technology that's valid, reliable, safe, fair, secure, and resilient.
You gain transparency, accountability, and explainability by design, so teams understand how AI works and can trust the insights it delivers. Every AI capability is built to provide measurable benefit while upholding lawful, ethical standards, supporting innovation without compromising integrity.
Security and Compliance Documentation
Data Security
Your clinical trials demand a secure, stable, and scalable environment. Medidata’s Information Security Program is built to protect highly sensitive data through multi-layered defenses and rigorous controls.
Based on the NIST 800-53 framework, security is embedded at the design stage across all products and services—ensuring the confidentiality, integrity, and availability of the data you entrust to us.
Protection includes encryption everywhere for data at rest, data loss prevention tools, and advanced firewall technologies. A global Information Security team monitors and manages safeguards 24x7x365, so protection never pauses.
Transparency is part of that protection. You receive visibility into detailed quarterly penetration tests, internal vulnerability scan summaries, and independent Tier 1 audits conducted by recognized experts, including PricewaterhouseCoopers, British Standards Institute, TÜV SÜD, SGS, and others.
Your advantage: continuous security, independent validation, and the assurance that your data is protected at enterprise scale.
Information Security Whitepaper (EN)
Information Security Whitepaper (JP)
Information Security Whitepaper (CN)
Information Security Whitepaper (KR)
Information Security Program Fact Sheet
ISO 27001:2022 Certificate
ISO 27017:2015 Statement of Conformity
ISO 27018:2019 Statement of Conformity
ISO 27701:2019 Certificate
Cloud Security Alliance (CSA) Star Registry (CAIQ)
Penetration Test Results
Vulnerability Scan Summaries
Statement on Security Incidents at Study Sites
Dassault Systémes Responsible Disclosure Program
Updated Statement on Ukrainian-Russian Conflict
MEDIDATA STATEMENT REGARDING CROWDSTRIKE ISSUE
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Validation Procedures
Your trials depend on proven, compliant, and inspection-ready software.
Medidata’s validation procedures are embedded within a rigorous quality management system (QMS) and a fully documented software development life cycle (SDLC). This foundation ensures the platform is fit for purpose and aligned with global regulatory requirements.
That same discipline extends to AI. Medidata applies a documented AI Validation Framework based on the NIST AI Risk Management Framework, ensuring AI capabilities are developed, assessed, and governed with the same rigor as core platform systems.
Validation does not end at deployment. Continuous post-deployment monitoring maintains every component in a validated state, with full version control, traceability, and auditability.
Your advantage: software—and AI—that is controlled, compliant, and built to withstand regulatory scrutiny.
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Documentation
Your programs require documentation that withstands scrutiny.
Medidata embeds transparency, traceability, and regulatory readiness into its QMS. Rigorous documentation policies ensure every stage of the data and product lifecycle is fully accounted for, controlled, and auditable.
Comprehensive standard operating procedures (SOPs) govern critical domains including Data Management, Access Management, and Operations—driving consistent, compliant execution across the platform.
All relevant metadata, audit trails, and supporting records are maintained within a centrally managed, version-controlled electronic document management system, ensuring complete traceability.
For AI and machine learning capabilities, detailed, up-to-date documentation is maintained and made available, supporting explainability, transparency, and regulatory confidence.
Your advantage: documentation discipline that protects your trials and withstands inspection.
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Accreditations and Certifications
Medidata’s Unified Protection Strategy integrates a secure, scalable cloud platform with rigorous data governance and an inspection-ready quality system to ensure compliant, reliable clinical trial execution.
Our Information Security, Privacy, and Quality Management teams work in unison to safeguard your data, ensure regulatory compliance, and maintain full transparency through extensive third-party attestations and certifications that validate our systems.
Security
Privacy
Regulatory
When It Comes to Meeting Strict Industry Guidelines, Medidata Has Done the Work.
Our Regulatory Compliance website contains documented position statements for Medidata customers, outlining how Medidata achieves compliance with key regulations such as ICH E6 (R2), ICH E6 (R3), 21 CFR Part 11, EU GMP Annex 11, the Ministry of Health, Labour and Welfare (MHLW) of Japan, the National Medical Product Administration of China (NMPA), and the FDA Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Q&A.
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