Define product profile
Confirm molecule type, temperature requirements, batch needs, and protocol-specific constraints.
Clinical Trial Supply
Sourcing Biologics & Biosimilars
Source large-molecule biologics and biosimilars for clinical environments with 2–8°C cold-chain aware handling and controlled documentation throughout.
Biologics and biosimilars introduce sourcing complexity beyond standard small-molecule comparators. McHade procures large-molecule therapeutics for clinical trial environments with cold-chain aware handling — 2–8°C where required — and the chain-of-custody documentation biologic programs demand.
From originator biologics to licensed biosimilars, sourcing is aligned to your protocol requirements and handled through a registered US wholesaler with GDP-aligned procedures.
Biologic sourcing integrates with comparator, RLD, and rescue services when study needs overlap — but each capability can be scoped and engaged on its own.
Who it's for
Built for protocols with temperature-sensitive large-molecule products
- Biologic trial sponsorsSource large-molecule products with temperature-aware handling and documented chain of custody.
- Biosimilar development programsProcure reference biologics and biosimilars with batch traceability for regulated study environments.
- CROs managing complex protocolsSupport multi-product trials where biologics require controlled sourcing beyond standard comparators.
What's included
Scope and deliverables
- Large-molecule sourcing for clinical trial environments
- 2–8°C cold-chain aware handling for temperature-sensitive products
- Validated shipping systems where refrigerated transit is required
- Chain-of-custody documentation for biologics and biosimilars
- Controlled sourcing aligned to protocol requirements
- Coordination with comparator, RLD, and rescue sourcing as needed
How it works
How McHade delivers this service
A clear operating path from protocol review through documented delivery to your study team.
Qualify supply channels
Identify licensed US sources and verify availability against study timeline and volume needs.
Source & protect
Procure product with 2–8°C handling where required and continuous temperature oversight in transit prep.
Document & deliver
Provide batch records and chain-of-custody documentation with shipment to your study depot or site.
DSCSA
Full DSCSA pedigree support and traceability standards across every shipment.
Quality & GDP
Operational quality controls with GDP-aligned storage, handling, and transportation procedures.
US Market Access
Regulatory and documentation support that simplifies compliant entry into and out of the US market.
Discuss Sourcing Biologics & Biosimilars
Share your protocol, comparator needs, product profile, and timeline. Our team will review the scope and respond with a compliant sourcing approach — turnaround depends on product complexity and regulatory requirements.