Request and authority check
Define sites, products, lots/kits, quantities and transport. Client-facing output: Transfer record.
Clinical trial logistics
Destruction
Destruction of returned and expired clinical trial supplies through an approved, documented process with counting, reconciliation and certified destructio…
IMPinvestigational product
IVDkits and reagents
MDmedical devices
End-to-endoperating model
Study close-out
Close returns and destruction through reconciliation
Stock/lot/kit reconciliation
Check package, identity, quantity and temperature evidence. Client-facing output: Reconciliation table.
Quarantine and segregation
Separate returns physically and in the system. Client-facing output: Contractor document.
Approved-contractor coordination
Compare dispatch, use, return, loss and remainder. Client-facing output: Destruction certificate.
Short answer
What does this service actually solve?
Returns and destruction reconcile unused products by lot, kit and quantity before written sponsor approval, waste segregation, authorised transfer and closure evidence.
Procurement brief
Destruction
Destruction closes unused supply through approval, reconciliation, segregation and documented contractor handling.
Included in scope
- Request and authority check
- Stock/lot/kit reconciliation
- Quarantine and segregation
- Approved-contractor coordination
- Outcome-document tracking
Outside scope
- Destruction without customer approval
- Closing unreconciled stock
- Acceptance of out-of-scope waste
Inputs we need
- Approved destruction list
- Product and waste classification
- Lot/kit/quantity data
- Witnessing requirements
Records delivered
- Transfer record
- Reconciliation table
- Contractor document
- Destruction certificate
Risks affecting timing
- Return and destruction-list mismatch
- Incorrect waste classification
- Incomplete approval chain
RACI
Decision and record ownership
Sponsor/CROReturn instruction, reconciliation decision and written destruction approval
SiteUse records, segregation and return handover
Omega DepotReceipt, quarantine, reconciliation and contractor coordination
ContractorWaste receipt, authorised treatment and certificate
Exception scenarios
Keep control when the plan changes
Return count differs from site record
Exclude from destruction until kit/lot investigation closes.
Product identity is unreadable
Quarantine separately and await sponsor decision.
Waste is outside contractor scope
Hold securely until an authorised route is confirmed.
Operating model
From uncertainty to a traceable outcome
Every project follows the same control logic, adapted to product and protocol requirements.
- 01
Return plan
Define sites, products, lots/kits, quantities and transport.
- 02
Return receipt
Check package, identity, quantity and temperature evidence.
- 03
Quarantine
Separate returns physically and in the system.
- 04
Reconciliation
Compare dispatch, use, return, loss and remainder.
- 05
Destruction approval
Submit the final list and waste class for written approval.
- 06
Contractor transfer
Preserve authorised chain and quantity/weight evidence.
- 07
Closure
Link certificate, reconciliation and exceptions to archive.
Service-specific FAQ
What to know before scoping
Can Omega destroy without sponsor approval?
No. The final list and authority chain require written confirmation.
Can returned product re-enter stock?
Only after defined quality assessment and authorised decision.
What is on the certificate?
As applicable: contractor, date, category/method, quantity or weight and reference.
Can destruction happen at a site?
Product, waste and local requirements need separate assessment; it is not default.
How is missing stock closed?
Investigation, sponsor explanation and accepted reconciliation are recorded.
Inside the facility
Real infrastructure, real operations
Omega Depot
Plan your next shipment with confidence
Share the product, route and timeline; our team will map a workable operational flow.