Archival Strengths:
- Data Protection
- Controlled Access
- Long Retention
Archival Services
Secure, Compliant Archival for Clinical Research
Hard copy archival is essential to ensure regulatory compliance, data integrity, participant safety and legal protection throughout and beyond the study lifecycle.
CliniApps provides secure, audit-ready archival services trusted by sponsors, CROs and research organizations.
Why Archival Matters
Hard copy archival remains the backbone of clinical research documentation by ensuring:
- Regulatory & GCP compliance
- Data integrity and source verification
- Participant safety and rights protection
- Inspection and audit readiness
- Long-term retention and legal protection
Why Choose CliniApps Archival Services
- Data protection for mission-critical records
- Compliance with legal and regulatory requirements
- Uniform archival implementation
- Cost-efficient, time-saving solutions
- Doorstep pickup and delivery
- Scanning and digitization support
- Quick and effortless retrieval
- Barcode-based file identification
- Compliance monitoring and reporting
- Backup and disaster recovery
- Secure document shredding
- Continuous process improvement
Safety-First Archival Framework
Regulatory & GCP Compliance
- ICH-GCP E6 (R2/R3) compliant retention
- DCGI/CDSCO, FDA 21 CFR 312, EMA, MHRA adherence
- Defined retention timelines
- Inspection-ready documentation
Document Security & Confidentiality
- Role-based restricted access
- CCTV surveillance and access logs
- Visitor control procedures
- Data protection compliance
Environmental Controls
- Temperature and humidity monitoring
- Pest control programs
- Fire, flood, dust and sunlight protection
Infrastructure & Storage Design
- RCC-constructed, independent facility
- Dedicated archival zones
- Fire-proof doors and cabinets
- Scalable storage capacity
- Study-wise document segregation
SOPs & Documentation Control
- Controlled receipt, storage, retrieval and destruction
- Version control and CAPA handling
- Approved archival SOPs
Indexing, Traceability & Retrieval
- Unique project identification
- Inventory logs
- Defined retrieval turnaround time
- Complete audit trails
Qualified & Trained Staff
- GCP-trained archival personnel
- Inspection-ready teams
- Documented training records
Disaster Recovery & Continuity
- Disaster management planning
- Backup storage options
- Emergency access protocols
Audit & Inspection Access
- Sponsor, regulatory and EC audits supported
- Supervised inspector access
- Immediate record availability
Record Retention & Destruction
- Retention per agreement and regulations
- Authorized destruction only
- Certificate of Destruction issued
Hybrid Archival (Physical + Digital)
- Controlled scanning processes
- Scan verification
- Secure physical-digital linkage
- ALCOA+ compliance
How It Works
- Order required archival boxes
- Pack documents securely
- Pickup arranged by CliniApps
- Secure storage at our facility
- Retrieve records as needed
Our Services
Language Translation Services
We deliver accurate, context-aware language translation services designed for clinical research and regulated industries. Our linguists ensure clarity, compliance and consistency across study documents, regulatory submissions and global communications.