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Evidilya, People & Research First®
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Quality & Compliance · Sponsor collaboration

Quality designed for confident collaboration.

Our quality framework brings governance, compliance, security and operational continuity together, giving sponsor teams a clear foundation for working with Evidilya.

People & Research First®
Eight connected domains

The structure behind our quality approach.

Together, these domains show how quality is organised across our studies, technology and delivery network, and what sponsor teams can explore with us.

Quality Management System

SOPs, controlled documents, training, CAPA and management review, reviewed against sponsor QMS expectations.

Regulatory compliance

ICH E6(R3), GCP/GVP, applicable EMA/FDA/MHRA guidance, and sponsor-specific SOP alignment.

Data governance

Ownership, sovereignty, EU hosting, retention, portability and clean exit, verified end-to-end.

Data security

ISO 27001-aligned controls, MFA, encryption, RBAC, immutable logging and penetration testing.

Business continuity

BCP/DR plans, incident response, backups and validated recovery objectives.

Vendor & site oversight

Qualification, monitoring and audit of subcontractors, sites and technology providers in our network.

21 CFR Part 11 & CSV

Validated systems, e-signatures, audit trails and computer system validation records.

Ethics & integrity

Code of conduct, anti-bribery, whistleblowing under Directive (EU) 2019/1937, conflict-of-interest and data ethics.

Looking for more on our quality approach?

Tell us about your study, or ask for the quality documentation relevant to your review.