TrialAssure Achieves ISO 27001:2022 Certification as Demand Grows for Trusted AI in Drug Development

Aug 20, 2026
Press release cover image

CANTON, Mich. (August 20, 2026) –TrialAssure, a leading technology provider advancing clinical trialtransparency, disclosure, and data sharing, today announced it has achievedISO/IEC 27001:2022 certification for its Information Security Management System(ISMS), further strengthening the company’s commitment to delivering secure,trusted technology across its growing portfolio of AI life science softwaresolutions.

ISO/IEC 27001:2022 is theinternationally recognized standard for ISMS and provides a comprehensiveframework for managing information security risks, protecting sensitive data,and continually improving security practices. Certification demonstrates thatTrialAssure's information security program has been independently audited andverified against globally recognized standards.

"AI has tremendouspotential to transform clinical development, but innovation like this must bebuilt on trust," said Prasad M. Koppolu, Chief Operating Officer atTrialAssure. "Achieving ISO 27001:2022 certification shows the level of carethat we take in protecting the sensitive information that our customers entrustto us every day. As organizations expand the use of AI across regulatedworkflows, they deserve technology that delivers high levels of innovationalongside strong information security."

As pharmaceutical andbiotechnology organizations continue adopting AI across medical writing,regulatory operations, and clinical trial transparency, information securityhas become a foundational requirement for innovation. TrialAssure's certificationprovides customers with added confidence that the company's technology platformis built upon internationally recognized security practices designed to protectsensitive clinical and regulatory information.

"AI is becoming partof everyday work across drug development, but successful adoption depends onfar more than model performance," said Zach Weingarden, MS, Director of AITechnology & Applications at TrialAssure. "Organizations needconfidence that their data is protected, their workflows are secure, and theirtechnology partner is prepared for the realities of regulated development. ISO27001:2022 certification is an important milestone in delivering thatconfidence."

The certification supportsTrialAssure's complete technology portfolio, including:

●       LINK AI for AI-assisted medical writing,

●       ANONYMIZE for document and dataanonymization,

●       REGISTRY for clinical trialdisclosure, and

●       TrialAssure’sbroader suite of solutions that help life sciences organizations simplifycompliance, improve operational efficiency, and support global transparencyrequirements.

To learn more aboutTrialAssure and its portfolio of secure AI and clinical technology solutions,visit: https://trialassure.com.

ABOUT TRIALASSURE

TrialAssure® is anaward-winning global data transparency company providing fast, intelligent, andcost-effective software and services for the pharmaceutical industry andrelated sectors. A recognized leader in artificial intelligence (AI) andmachine learning (ML), TrialAssure offers AI Enabled, Human Driven™ solutionsthat support compliance through document and data anonymization, AI-assistedcontent development, compliance tracking, and clinical trial disclosure.Founded in 2009, TrialAssure’s global team builds proven technology platformsthat help Sponsors and research organizations stay aligned with transparencyregulations worldwide. TrialAssure was named Data Solution of the Year by theData Breakthrough Awards.

For more information, visit www.trialassure.com

Media Contacts

Don F. McLean, [email protected] 

Read the original article: BioSpace