Clinical Trial Supply in Canada
Comparator and study-drug sourcing for research teams, with protocol-led documentation and vendor qualification
Clinical trial supply is everything a study needs that the sponsor does not manufacture itself: the marketed comparator, concomitant and rescue medications, and the licensed storage and distribution that moves them to sites without breaking the chain of custody. Nexara Health provides that service under Health Canada Drug Establishment Licence #3-002896 from 9 South Landing Dr, Unit 116, Winnipeg, MB R4G 0C4, Canada.
We work from the protocol and the pharmacy manual, not from a product list. For each line we confirm the exact presentation, strength and pack, the marketing authorization holder in the chosen source market, expiry dating on arrival, and whether the product can be blinded or overlabelled. Where more than one source market is acceptable we quote each so the sponsor can see cost, lead time and remaining shelf life side by side.
Standard enquiries are quoted within 24 hours of receiving the product name, strength, presentation, quantity and study timeline. Rescue supply for shortage events, failed vendor deliveries and mid-study amendments is available and is where a licensed Canadian wholesaler with direct market access matters most.
What is included
- Health Canada DEL #3-002896 — import, wholesale and storage authorizations
- Comparator and reference-listed drug sourcing from 40+ regulated markets
- Concomitant, rescue and background medication sourcing
- Canadian-labelled product for US and EU studies where the protocol allows
- GDP-compliant 2–8 °C, −20 °C and −80 °C storage with continuous monitoring and excursion reporting
- Certificate of Analysis, TSE/BSE statements and full chain-of-custody records
- Overlabelling, matched placebo and blinding handoff to the sponsor's packager
- Depot storage in Winnipeg and direct-to-site distribution across Canada
- Returns, reconciliation and witnessed destruction at study close-out
IND, IND exemption and IRB review
Whether a study requires an IND or qualifies for an exemption depends on the protocol and applicable regulatory criteria. The sponsor and its regulatory team determine the pathway; sourcing a Canadian-labelled product does not itself establish an exemption.
Share the protocol requirements and any planned IRB modifications before selecting a comparator or study-drug presentation. Product and supply documentation supports your review; it is not a regulatory determination.
Vendor approval and institutional onboarding
Send your institution's vendor questionnaire, procurement-portal requirements and requested tax documentation for review. W9-style requests and Coupa workflows should be assessed against the contracting entity and jurisdiction rather than assumed to apply.
Identify the licence evidence, applicable GMP documentation, lot records and chain-of-custody information your study requires. Confirm the available documents and responsibilities before placing an order.
What is included in clinical trial supply?
Sourcing of the marketed products a study needs (comparator, active control, co-medications, rescue medication), licensed import into Canada where the source market is abroad, GDP storage at the correct temperature, release documentation for each lot, and distribution to sites or to the sponsor's packager. Investigational product manufacture is not included; we handle the marketed side of the trial and the logistics around it.
Why source trial supply from Canada?
Canada publishes a full Drug Product Database, so every product we quote can be checked against its DIN, marketing status and monograph before a purchase order is raised. Canadian product carries English labelling, which reduces translation and relabelling work for North American studies. Health Canada's Drug Establishment Licence regime means the importer, wholesaler and storage site are inspected entities, and that documentation travels with the product.
For sponsors outside Canada, the practical questions are regulatory justification and equivalency. We provide the manufacturer's equivalency statement where one exists and the Canadian regulatory record for the product so the sponsor's regulatory team can make the case early, before the supply plan is locked.
How is the source market chosen?
The protocol decides. If it names a specific marketing authorization holder or presentation, we source that. If it allows any product with the same active ingredient, strength and form, we price the Canadian product against EU, UK, US and other regulated markets and show the trade-off. Restricted or single-source products are quoted with the realistic lead time rather than an optimistic one.
Documentation, and why it decides audits
Every shipment leaves with the Certificate of Analysis, the lot and expiry record, temperature data for the full journey, and the licences of every establishment that handled it. Sponsors and CROs are audited on this paper long after the study closes, so it is prepared at the time of shipment, not reconstructed later.
Cold chain and handling
Refrigerated, frozen and ultra-low-temperature products are stored in mapped, monitored zones and shipped in validated packaging with continuous temperature logging. Any excursion is reported with the data and a disposition recommendation; nothing is silently accepted.
Working with study timelines
Send the protocol excerpt or the supply list with strengths, presentations and quantities, the first-patient-in date and the destination sites. We return a quote within 24 hours for standard products with delivery in 1–3 weeks from Canadian, EU or US stock and 4–8 weeks for restricted markets. Recurring resupply is scheduled against the enrolment forecast so stock is usable on arrival.
Frequently asked questions
What is the difference between clinical trial supply and comparator sourcing?
Comparator sourcing is one part of clinical trial supply: buying the marketed product the investigational drug is measured against. Clinical trial supply also covers concomitant and rescue medications, storage, distribution to sites, reconciliation and destruction.
Is Nexara licensed to import and store trial supply in Canada?
Yes. Health Canada Drug Establishment Licence #3-002896 covers import, wholesale and storage from our Winnipeg facility.
Can you supply a US or EU trial from Canada?
Yes, where the protocol and the sponsor's regulatory authority accept Canadian-registered product. We provide the Canadian regulatory record and the manufacturer's equivalency statement where available so the sponsor can justify the source.
How fast can trial supply be sourced?
Standard products are quoted within 24 hours and delivered in 1–3 weeks from Canadian, EU or US stock. Restricted or single-source products typically take 4–8 weeks.
Do you handle cold chain trial supply?
Yes — 2–8 °C, −20 °C and −80 °C, with continuous monitoring and excursion reporting on every shipment.
Do you support blinding, overlabelling and placebo?
We supply matched comparator presentations, arrange overlabelling and hand off to the sponsor's packager for blinding; matched placebo is arranged through qualified manufacturers.
What happens to unused stock at study close-out?
Unused product is reconciled against the dispensing record, returned to our depot and destroyed under witness with a certificate of destruction for the trial master file.
Request a quote
Nexara Health is a Health Canada–licensed pharmaceutical wholesaler (DEL #3-002896) based in Winnipeg, Manitoba, supplying hospitals, pharmacies, clinics, CROs, and trial sponsors across Canada. Send us the product, strength, presentation, and quantity for clinical trial supply in canada and we will come back with availability, source market, lead time, and landed cost — usually within 24 hours.
Request a sourcing quote or call +1 (431) 588-9055.