Compounding for clinical research
Study medication, prepared and documented to the standard your protocol demands, from feasibility review through final visit.
The lab and the discipline your trial needs
A 9,000 sq ft sterile facility, a team with cGMP experience, and the documentation habits of a pharmacy that expects to be inspected. Sponsors and CROs get one accountable partner for study drug, from the first feasibility call to the last resupply.
- Sterile and non-sterile preparations in ISO-5 hoods that exceed USP <797>, with USP <800>-compliant handling of hazardous drugs.
- Ingredients from qualified suppliers, traced lot by lot with certificates of analysis on file.
- Blinding, matched placebo and kit labelling aligned with your randomisation scheme.
- Compounders with cGMP experience, trained for both sterile and non-sterile work.
A facility built for scrutiny
Accredited since 2020
Pharmacy Compounding Accreditation Board accreditation for sterile and non-sterile compounding, renewed through independent survey.
Verified Pharmacy Program inspected
Inspected under the National Association of Boards of Pharmacy programme, with licensure in all 50 states and DC for multi-site studies.
Cleanrooms beyond the standard
ISO-5 performance exceeded in every hood, USP <800> hazardous-drug handling in place, LegitScript certified.
Built around your protocol, not the other way round
Investigational preparations rarely fit a catalogue. We compound to the strength, form and batch size your study design calls for, and change with it as the protocol amends.
- A range of strengths
- Multiple dosage forms
- Various routes of administration
- Excipient and base selection
- Blinded or unblinded product
- Batches sized to enrolment
From protocol to pharmacy manual
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1
Feasibility review
We review your protocol and confirm what we can prepare, package and document.
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2
Preparation plan
Formulation, blinding and labelling plan, agreed with your team before anything is made.
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3
Supply & support
Reliable resupply and responsive communication through study close-out.
Clinical trial questions, answered
Anything else, ask us in the form below and a pharmacist will reply.
Yes. We compound the active preparation and a placebo matched for appearance, taste and handling, and package both under blinded kit labels aligned with your randomisation scheme.
Sterile and non-sterile forms: injectables, capsules, troches, topicals and more, at the strengths the protocol specifies. If a form or strength isn't feasible we say so at the feasibility review, not after.
We are licensed in all 50 states and DC, so a single pharmacy can supply every US site in your study. Ask us about studies with sites elsewhere.
Batch records, certificates of analysis for ingredients, beyond-use dating with its rationale, and the stability considerations your monitors will ask for.
As small as your enrolment needs. Compounding is made to order, so we can match early-phase quantities and scale as the study grows, without minimum runs.
Send the basics through the form below. We review the protocol, confirm feasibility, agree a preparation plan with your team, and only then start making anything.
Tell us about your study
Share the basics and our team will schedule a feasibility conversation.
