Skip to main content

Take our TMF Risk Score Survey today!

Improve Quality and Reduce Risk in Clinical Trials

Increase data integrity and audit preparedness. Trial Interactive offers tools to help QA professionals clear a compliant, risk-mitigated path through clinical trial complexity.

Trial Interactive meets a host of regulatory certification requirements.

Achieve Global Compliance


21 CFR Part 11

TI’s 21 CFR Part 11 compliant eClinical platform provides assurances for audit trail functionality, for example eTMF audit trails, electronic signatures, security and data integrity, record retention, etc.

ISO 9001:2015

TI’s QMS complies with the ISO 9001:2015 international standard and is audited in accordance to enhance customer satisfaction.

SSAE 16 SOC 2 Type 2

All data centers comply with this standard for reporting on controls at service organizations.

Annex 11, GDPR, Privacy Shield

Audited on rigorous quality standards for businesses – staffing, training, production, information management, and quality control measures.


TI’s policies and procedures are designed to comply with this standard and employees are required to pass introductory training.


Our computerized systems are GAMP 5 compliant and are evaluated based on the framework’s risk-based approach.

Automate and Improve Quality Processes and Management

Our Quality Suite helps life sciences organizations gain visibility into quality processes and increase process efficiencies.

Download The Ultimate TMF Resource Pack (2023 Edition)

Want to know your TMF Inspection Risk Score or determine the right-fit TMF management vendor? Get our TMF resource pack to gain critical insights into the state of your TMF.


Quality assurance teams can manage standard operating procedures, policies, and any other documents from approved templates as required by the quality manual. Author, edit, approve, and manage quality documents.

Simplify quality knowledge management by connecting quality document processes to your training management.

  • Approve with eSignature

  • Share Approved Document to Training Management

  • Document Becomes Effective

  • Draft from Template, Edit, and Collaborate on Document