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

  • Trial Master File (TMF) archival
  • Investigator Site File (ISF) management
  • Regulatory submission document storage
  • Pharmacovigilance documentation
  • Medical device technical documentation
  • CSR & protocol archival
  • Electronic and physical document management

Compliance Standards

  • ICH-GCP guidelines
  • CDSCO / DCGI requirements
  • FDA & EMA retention standards
  • ALCOA+ data integrity principles
  • Data privacy & confidentiality regulations

Features

  • Structured indexing & cataloging
  • Digital document conversion (if required)
  • Access-controlled storage systems
  • Retrieval support during audits
  • Retention policy guidance

Benefits

  • Inspection readiness
  • Reduced document loss risk
  • Secure & organized storage
  • Regulatory-compliant retention
  • Faster audit support

Quick Contact

  • Email:

    business@landmarkcro.com

  • Phone:

    +91 999 888 5186

  • Location:

    Ahmedabad, India

Landmark CRO
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