Study start-up requirements
Collect protocol, product, country, site and target dates. Client-facing output: Start-up checklist.
Clinical trial logistics
Omega Depot Clinical Trial Support Services
Clinical-trial support services: one country operating plan connecting permits, import, inventory, site supply and close-out from study start-up to archive.
IMPinvestigational product
IVDkits and reagents
MDmedical devices
End-to-endoperating model
Study operations
Keep product, inventory and site plans connected
Product and site master data
Sequence permits, import, sourcing, systems and quality decisions. Client-facing output: Operating instruction.
Inventory and order coordination
Verify product, site, contact, stock unit and reporting rules. Client-facing output: Periodic inventory report.
Urgent-need and change control
Model stock from activation, patient/visit and lead time. Client-facing output: Close-out package.
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 service2–8 °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 service2–8 °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 service2–8 °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 service15–25 °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 serviceSource: 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?
Clinical-trial support connects product, site, permission, inventory, order and escalation dependencies in one country operating plan from start-up to close-out.
Procurement brief
Omega Depot Clinical Trial Support Services
Clinical-trial support joins import, inventory, site and supply activity in one operating plan.
Included in scope
- Study start-up requirements
- Product and site master data
- Inventory and order coordination
- Urgent-need and change control
- Study close-out support
Outside scope
- Sponsor clinical decisions
- Protocol-deviating movements
- Unscoped site services
Inputs we need
- Protocol and study overview
- Product and site plan
- Patient and consumption estimate
- System and reporting needs
Records delivered
- Start-up checklist
- Operating instruction
- Periodic inventory report
- Close-out package
Risks affecting timing
- Forecast not following study change
- Site activation and stock misalignment
- Unclear escalation ownership
RACI
Decision and record ownership
SponsorProtocol, budget, clinical decisions and final scope
CROSite/study coordination and delegated decisions
Omega DepotLocal operating plan, inventory/logistics coordination and records
Sites/suppliersAssigned data, delivery, use and service duties
Exception scenarios
Keep control when the plan changes
Site activation moves earlier
Update stock assumptions and confirm feasibility before commitment.
Protocol or product list changes
Place affected permits, orders, stock and training under change control.
Consumption exceeds forecast
Build recovery from remaining stock, lead time and safety stock.
Operating model
From uncertainty to a traceable outcome
Every project follows the same control logic, adapted to product and protocol requirements.
- 01
Start-up brief
Collect protocol, product, country, site and target dates.
- 02
Dependency map
Sequence permits, import, sourcing, systems and quality decisions.
- 03
Master data
Verify product, site, contact, stock unit and reporting rules.
- 04
Demand plan
Model stock from activation, patient/visit and lead time.
- 05
Active management
Track orders, stock, changes, urgent needs and exceptions.
- 06
Periodic control
Report verified stock, movements, actions and risks.
- 07
Close-out
Close return, reconciliation, destruction and archive duties.
Service-specific FAQ
What to know before scoping
Does Omega make clinical decisions?
No. It presents operational options and impact; authorised sponsor/CRO retains clinical decisions.
What is in the operating plan?
Roles, timing, dependencies, master data, reporting and escalation.
Is IRT integration mandatory?
It depends on the study; an approved manual order model can be scoped.
How is forecast updated?
Activation, patient/visit, use, loss and lead-time assumptions are reviewed.
When is close-out planned?
Owners are set during scoping and converted into a detailed schedule before study end.
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.