Returns management & reconciliation

At the end of a clinical trial, or when products reach their expiry date at site level, investigational materials are returned to our facility for controlled processing.

Our dedicated teams manage the complete returns workflow to ensure full accountability, regulatory compliance and accurate inventory reconciliation.

Returns verification

Upon receipt, all returned products are thoroughly inspected and documented.

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Verification activities include: 

  • Counting unopened, partially used and used units 
  • Assessment of returned quantities and product status 
  • Documentation of returns in dedicated inventory systems 
  • Full traceability of returned materials 

Inventory reconciliation

A comprehensive reconciliation process is performed to confirm the accountability of all clinical trial supplies throughout the study.

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This involves comparing: 

  • Quantities originally shipped to each site 
  • Quantities returned 
  • Quantities reported as dispensed or administered 

Any discrepancy identified during reconciliation is investigated through a documented process to determine the root cause and ensure complete product accountability.

Secure quarantine management

All returned materials are placed in a dedicated quarantine area, physically separated from active and released inventory to prevent any risk of mix-up or unintended reuse.

Our robust returns and reconciliation procedures provide sponsors with full visibility of product accountability while supporting regulatory compliance and audit readiness throughout the clinical trial lifecycle.

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This controlled segregation ensures: 

  • Clear distinction between returned and released stock 
  • Compliance with GMP and study requirements 
  • Secure storage pending reconciliation, disposition or destruction activities 
  • Complete traceability throughout the returns management process 

Product destruction management 

Following completion of the reconciliation process and sponsor approval, returned or obsolete or expired clinical trial materials are removed from inventory and destroyed through qualified waste management partners.

Controlled destruction process

We coordinate the entire destruction process to ensure compliance with regulatory, environmental and study-specific requirements.

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Our services include: 

  • Management of products approved for destruction 
  • Coordination with qualified and licensed destruction providers 
  • Secure handling and transfer of materials 
  • Destruction of investigational, comparator and ancillary products 
  • Compliance with applicable GMP and local regulations 

Documentation & traceability

Full traceability is maintained throughout the destruction process, providing sponsors with complete visibility and audit-ready records.

By managing product destruction through an established network of qualified partners, we ensure the secure, compliant and fully documented disposition of clinical trial materials at the end of their lifecycle.

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Documentation includes: 

  • Verification of quantities approved for destruction 
  • Certificates of destruction issued by approved partners 
  • Archiving of destruction documentation in accordance with project requirements 
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