Inspection-ready trial master file management

Omega eTMF — Electronic Trial Master File

Omega's own electronic Trial Master File platform: the essential document set of every clinical trial — collected, classified and archived in an inspection-ready structure from start to close-out.

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المعايير: 21 CFR Part 11 İKU Temel Dokümanlar ALCOA+ KVKK

المزايا الرئيسية

Artifact taxonomy

Trial master file organized into zones, sections and artifacts for direct evidence retrieval.

Metadata & search

Full-text search and filtering by study, document type, country and date.

Versioning & audit trail

Every upload and approval recorded; prior versions always retrievable.

Part 11 e-signatures

Approval workflows with compliant electronic signatures.

Inspection-ready archive

Retention policies and export packages that respond to authority requests in minutes.

Role-based access

Access and task assignment by role and study team.

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فريقنا جاهز لمساعدتك على التعرّف على كيفية دعم Omega CRO لاحتياجاتك من التجارب السريرية.

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