Comparator Sourcing & Clinical Trial Supply
Comparator and reference products sourced from the market your protocol specifies, with validated chain of custody, batch consistency and the import documentation your sites actually need.
Comparator supply is a documentation problem, not a purchasing problem
Buying a licensed innovator product is easy. Buying it in a way that will survive a regulatory inspection of your trial is not. The comparator has to come from an acceptable market, carry an unbroken chain of custody back to a legitimate distribution channel, and ideally come from a single batch with enough remaining shelf life to cover the whole study.
Those constraints are what make comparator sourcing slow, and they are where studies get held up. A comparator obtained cheaply through an unverifiable channel is worth nothing if the sponsor cannot demonstrate provenance later.
We work backwards from the protocol and the inspection requirement, not from the price list.
What holds studies up
- Comparator sourced from a market the protocol does not accept
- Multiple batches where the protocol assumed one
- Residual shelf life shorter than the study duration
- Chain of custody with an unverifiable link
- Missing Certificate of Conformity or Authenticity
- Import permit not secured before the shipment moves
- Labelling that does not meet the destination's trial requirements
What we supply
Comparator products
Innovator and reference-listed products sourced from the specific market your protocol or regulator requires, with country of purchase documented.
Reference standards
Pharmacopoeial and working reference standards for APIs, excipients and impurities, supplied with certification and stability-preserved packaging.
Biologics & vaccines
Temperature-controlled comparator biologics and vaccine references, with continuous data-logger records and qualified shipping systems.
Ancillary supplies
Rescue and background medication, placebo-matching support, and co-administered products needed to run the protocol.
Documentation for trial supply
- Certificate of Conformity
- Certificate of Authenticity
- Batch-specific Certificate of Analysis
- Documented chain of custody from point of purchase
- Country of purchase and distribution channel record
- Invoice and packing list matched to batch and quantity
- Continuous temperature record where applicable
- Import permit and licence support for the destination
- Remaining shelf-life declaration at dispatch
- Original manufacturer packaging retained and photographed
How a comparator project runs
Which markets are acceptable as a source, is single-batch supply required, what is the minimum shelf life at last dose, and what does the destination regulator require for import of trial material.
We confirm real availability of a single batch in sufficient quantity with adequate residual shelf life, before quoting. Where a single batch is not achievable we say so early so the protocol can be adjusted rather than the study delayed.
Price, batch details, shelf life and lead time quoted together, with the stock reserved for a defined period so it does not disappear during your approval cycle.
Purchase through a licensed distribution channel with each transfer documented, original packaging retained and photographed, and storage conditions logged throughout.
Permit and licence support for the receiving country, qualified shipping system for temperature-sensitive material, and delivery to your depot, CRO or investigator site as instructed.
Where enrolment extends or sites are added, we hold source details on file so a top-up can be matched to the original batch wherever it remains available.
Who we work with
- Sponsors running multi-country studies needing consistent comparator supply
- CROs and clinical supply teams managing sourcing on a sponsor's behalf
- Bioequivalence centres requiring a locally acceptable reference product
- Academic and biotech R&D groups needing reference standards with full traceability
- Generic developers sourcing the innovator product for comparative studies
Send us your comparator requirement
Product, strength, quantity, acceptable source markets, required shelf life and destination country. We will confirm availability and batch position before quoting.
Submit Study Requirement Talk to our teamRelated services
Frequently Asked Questions
Comparator and reference material is supplied for research and clinical study use by qualified organisations. We do not supply medicines to individuals, and nothing on this page constitutes medical advice or a recommendation for patient treatment.
