For sponsors, CROs and procurement teams
Comparator drug sourcing for clinical trials
GNH Pharmaceuticals USA LLC accepts comparator sourcing enquiries from sponsors, CROs and procurement teams. Share the reference product or active comparator specification, the source-market requirements and the delivery schedule so the team can review the request.
A product name alone may leave important questions open. Presentation, pack size, batch requirements and remaining shelf life can affect whether a proposed supply fits your study. Availability, documentation and delivery arrangements need confirmation for each enquiry.
For rescue medication, co-medication or a broader study-material request, see clinical-trial supply.
Prepare an enquiry
Discuss your comparator requirement
Send your organization, product specification, quantity, destination and required-by date. Add any source-market, batch or expiry constraints.
RFQ checklist
What to include in a comparator sourcing request
A clear specification helps the team identify missing information before discussing supply options. If a detail is undecided, mark it as unknown rather than assuming an alternative is acceptable.
- Product: brand or reference product, active ingredient, strength and dosage form.
- Presentation: pack size, language or labelling requirements, and any acceptable alternatives for review.
- Source market: the required market or markets and any restrictions set by your study team.
- Quantity: packs or units, number of deliveries, and expected replenishment needs.
- Batch and shelf life: single-batch preferences, batch restrictions and minimum remaining shelf life at delivery.
- Schedule and destination: required-by dates, delivery locations and whether the request is for initial or ongoing supply.
- Documentation: the specific records your procurement or quality team needs to assess an offer.
Use the message field for details that do not have a dedicated field. Share confidential protocol documents only through a separately agreed secure channel; do not include patient information in the enquiry.
Procurement review
Questions to resolve before accepting a supply proposal
Match the exact presentation
Ask whether the proposed strength, form, pack and source market match the submitted specification. Identify differences for your study team to assess.Confirm available documentation
List the documents you need and confirm which can be provided for the specific product and sourcing route. Do not assume one standard pack applies to every request.Check timing and remaining shelf life
Discuss the required-by date, expiry constraints and delivery stages together. Confirm the proposed schedule before relying on it in study planning.Clarify handling and responsibilities
Identify storage and transport requirements, destination constraints and the responsibilities of each party in the proposed arrangement.
Compare proposals
Review a comparator sourcing offer against the study specification
Compare offers on the same basis before comparing pack prices. Record any proposed difference and ask the responsible study or quality team to assess it.
- Product match: compare the offered brand, strength, dosage form, pack and source market with the requested reference product. A shared active ingredient alone does not establish an acceptable substitution.
- Usable quantity: record the packs or units offered, batch allocation and remaining shelf life against the planned delivery stages. Distinguish a confirmed allocation from an indication of availability.
- Evidence to review: ask which product, batch, expiry, sourcing and handling records can be supplied. Request a sample document list where appropriate; document availability must be confirmed for that offer.
- Delivery and commercial scope: identify included transport arrangements, destination responsibilities, quote validity and any exclusions. Resolve differences before treating two offers as equivalent.
If the request spans rescue medication, co-medication or several delivery stages, describe the wider scope using the clinical-trial supply planning checklist.
Next steps
From an initial enquiry to a defined request
Submit the specification through the Sponsor & CRO enquiry form and select Comparator sourcing. The team can then identify questions that need clarification and discuss feasibility and next steps.
An enquiry is not an availability confirmation or a supply commitment. Review the proposed product, documentation, timing and commercial terms before agreeing an order. Decisions about suitability for a study remain with the responsible study and quality teams.
FAQ
Frequently asked questions
What should I include in a comparator sourcing RFQ?
Include the product or reference brand, active ingredient, strength, dosage form, pack size, quantity, source-market constraints, batch and expiry requirements, delivery destination and required-by date. Mark unknown details clearly.
Can I enquire before the final quantity is known?
Yes. The Sponsor & CRO enquiry form allows quantity to be left blank. Explain what is still being planned and provide an estimate or delivery stages if available. Feasibility and terms still need review.
Which documents will be available with the product?
Specify the documents your procurement or quality team requires. The available documentation must be confirmed for the particular product and sourcing route; the enquiry does not guarantee a standard documentation pack.
Does a catalogue listing confirm comparator availability?
No. Submit the exact presentation and sourcing requirements for review. A listing does not confirm current stock, remaining shelf life, suitability for a study or delivery timing.
How do comparator sourcing and clinical-trial supply enquiries differ?
Use this page for reference-product or active-comparator procurement. Use the clinical-trial supply page for broader study-material planning, including requests involving rescue medication, co-medication or several material types.
Case studies
Sourcing challenges in practice
Read how sourcing, quality documentation and logistics came together in an Nplate clinical-trial supply assignment.
For a complex order involving replacement supply, documentation and shipment planning, see the Ocrevus sourcing case study.
Related
Other services
Clinical Trials Supply
Discuss clinical-trial supply with GNH USA. Share study-material specifications, quantities, destinations and delivery stages for a sourcing review.
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