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
Information Security
Data security at Medidata is the highest priority. We lead the industry in security and compliance using state-of-the-art technology and techniques, coupled with a strategy that supports our scalable, secure and stable environment, Medidata holds over twelve security certifications, six agency certifications, and built on four highly valued frameworks. We continuously improve our security capabilities and educate our workforce with the latest techniques to protect all of your clinical study data.
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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Data Privacy
In addition to our robust GDPR compliance program, Medidata achieved one of the first independent ISO certifications for Privacy and for Service Organization Control 2 (SOC2) over Privacy. Privacy protection is built into the entire service lifecycle at Medidata. From our GDPR-ready Data Processing Exhibit and integrated Privacy-by-Design to our industry-leading Data Governance program, Medidata is committed to accountability for how we steward your sensitive clinical trial data anywhere on our platform.
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Quality Management
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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