Secure. Structured. Compliant.
Proper archival of clinical research documents is critical for regulatory inspections, audits, and long-term compliance. We provide secure document archival and record management services aligned with global regulatory requirements.
Our services ensure that essential documents are systematically stored, traceable, retrievable, and audit-ready throughout the retention lifecycle.
Scope of Archival Services
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Trial Master File (TMF) archival
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Investigator Site File (ISF) management
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Regulatory submission document storage
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Pharmacovigilance documentation
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Medical device technical documentation
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CSR & protocol archival
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Electronic and physical document management
Compliance Standards
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ICH-GCP guidelines
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CDSCO / DCGI requirements
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FDA & EMA retention standards
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ALCOA+ data integrity principles
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Data privacy & confidentiality regulations
Features
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Structured indexing & cataloging
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Digital document conversion (if required)
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Access-controlled storage systems
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Retrieval support during audits
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Retention policy guidance
Benefits
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Inspection readiness
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Reduced document loss risk
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Secure & organized storage
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Regulatory-compliant retention
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Faster audit support