Clinical trial logistics

Storage

Validated ambient, refrigerated and frozen investigational medicinal product storage with continuous temperature and security monitoring.

IMPinvestigational product
IVDkits and reagents
MDmedical devices
End-to-endoperating model

Depot control

Protect inventory status as carefully as product conditions

01

Receipt and product checks

Define product, temperature, stock unit and quarantine instructions. Client-facing output: Receipt record.

02

Quarantine and released-stock segregation

Check package integrity, identity, quantity and temperature evidence. Client-facing output: Inventory and movement report.

03

Traceable temperature-controlled storage

Separate quarantine, released, blocked and returned stock. Client-facing output: Temperature data or summary.

04

Expiry and movement records

Monitor the assigned zone, sensors, access and locations. Client-facing output: Deviation and dispatch records.

Client-anonymized operating experience

The operating scope of past projects

Client names remain private; vaccine studies are shown by name with their own project figures.

15–25 °C · Multi-site programme

Nationwide supply for a smoking-cessation programme

Project scope224 centres · 164,733 participants · 247,435 medicine boxes

The project summary records medicine supply at 15–25 °C across a network involving 400 physicians and 650 assistant healthcare personnel. The box and participant figures belong to this past programme.

For sponsors: Site-level demand, stock units and the delivery calendar should be defined together at the start of scoping.

Distribution service

2–8 °C · Phase 3

Coronovac Phase 3

Project scope24 sites · 26,180 vaccines · 2–8 °C

The Coronovac Phase 3 summary records a 24-site scope for vaccines with a 2–8 °C temperature profile. This quantity belongs to this Phase 3 study alone and is not combined with the other vaccine projects.

For sponsors: Site allocation and cold-chain requirements should be specified for each study and shipment plan.

Storage service

2–8 °C · Phase 3

Turkovac Phase 3

Project scope8 sites · 1,290 people × 2 administrations · 2,580 vaccines

The Turkovac Phase 3 summary lists 2,580 vaccines for two administrations to 1,290 people across eight sites under a 2–8 °C profile. Participant, administration and product counts are distinct planning inputs.

For sponsors: Calculate product demand from the administration schedule, not the site count alone.

Storage service

2–8 °C · Phase 2b

Rapel Phase 2b

Project scope41 sites · 4,340 vaccines · 2–8 °C

The Rapel Phase 2b summary records 4,340 vaccines across a 41-site study scope under a 2–8 °C profile. The breadth of the site network is a planning variable separate from product quantity.

For sponsors: Prepare site-level demand, delivery windows and recipient contacts separately.

Storage service

15–25 °C · Non-drug study

Research material for a non-drug clinical study

Project scope14 sites · 4,484 boxes · 15–25 °C

The summary of a clinical study described as non-drug records 4,484 boxes of research material for 14 sites under a 15–25 °C profile. The product is not labelled as a medicine or medical device without a separate classification check.

For sponsors: State the product classification, box/stock unit and site allocation in the initial brief.

Distribution service

Source: past project summaries supplied by Omega. Quantities and times describe only the relevant historical examples, not current capacity or a delivery commitment. The source does not distinguish vaccine doses from vials.

Short answer

What does this service actually solve?

Controlled storage governs quarantine/released status, lot and expiry, access, alarms and deviation decisions from receipt to dispatch—not temperature alone.

Procurement brief

Storage

Controlled storage manages receipt, stock status, access, alarms, deviations and release instructions as one system.

Included in scope

  • Receipt and product checks
  • Quarantine and released-stock segregation
  • Traceable temperature-controlled storage
  • Expiry and movement records
  • Alarm and deviation escalation

Outside scope

  • Sponsor quality-release decisions
  • Automatic acceptance of undeclared hazardous goods
  • Repacking outside written scope
01

Inputs we need

  • Product and stock-unit list
  • Temperature and light conditions
  • Quarantine/release instructions
  • IRT and ordering requirements
02

Records delivered

  • Receipt record
  • Inventory and movement report
  • Temperature data or summary
  • Deviation and dispatch records
03

Risks affecting timing

  • Incorrect storage profile
  • Status mismatch between systems
  • Outdated alarm contacts

RACI

Decision and record ownership

Sponsor/CROStorage condition, stock status, release and deviation authority
Shipper/carrierQualified transport, logger and handover records
Omega DepotReceipt, segregation, monitoring, inventory records and alarm escalation
Authorised quality partyDisposition after a temperature event

Exception scenarios

Keep control when the plan changes

Logger shows an excursion

Block stock, preserve data and send it for authorised impact assessment.

Unexpected or unidentified package arrives

Segregate it until identity and receipt instruction are confirmed.

Expiry is approaching

Report at agreed thresholds and plan distribution, return or destruction.

Operating model

From uncertainty to a traceable outcome

Every project follows the same control logic, adapted to product and protocol requirements.

  1. 01

    Receipt planning

    Define product, temperature, stock unit and quarantine instructions.

  2. 02

    Goods receipt

    Check package integrity, identity, quantity and temperature evidence.

  3. 03

    Status assignment

    Separate quarantine, released, blocked and returned stock.

  4. 04

    Controlled storage

    Monitor the assigned zone, sensors, access and locations.

  5. 05

    Inventory control

    Report lot/kit/serial, expiry, FEFO and movements.

  6. 06

    Alarm and deviation

    Escalate limit events while keeping disposition with the authorised party.

  7. 07

    Dispatch release

    Prepare only against approved instructions and valid stock status.

Service-specific FAQ

What to know before scoping

Does Omega decide whether product is usable?

Omega supplies supporting records; disposition remains with the authorised party unless formally delegated.

Which temperature ranges are supported?

Current verified facility scope is matched to the product during qualification.

What does an inventory report contain?

As scoped: product, lot/kit/serial, status, location, quantity, expiry and movement.

Is quarantine physically segregated?

Physical location and system status are used together.

Who receives an alarm?

The approved escalation list, thresholds and out-of-hours contacts govern notification.

Omega Depot

Plan your next shipment with confidence

Share the product, route and timeline; our team will map a workable operational flow.

Talk to our team