CRO harmonised a peptide reference standard across 6 sites for a sponsor-driven multi-arm study in 6 weeks
A global contract research organisation running a multi-arm sponsor-driven preclinical pharmacology study needed the same peptide reference standard, with traceable lot continuity, delivered to six study sites across three regions. Forecast-based reservation against a single locked synthesis route closed the campaign without lot-to-lot variance complaints from sponsor QA.
Published May 5, 2026 · Anonymized research-buyer story
RFQ → first site shipment
6 weeks
Sites supplied from locked route
6
Sponsor QA rejection rate
0
Forecast horizon
6 months
Challenge
The CRO's Project Manager faced a multi-arm preclinical pharmacology campaign running concurrently across six sites in three regions, with a sponsor QA team that required all sites to receive material from the same synthesis route and equivalent analytical packets. The CRO's previous supplier had been releasing the same SKU from two different upstream synthesis routes depending on which batch was available at ship time, which made the sponsor QA team reject the cross-site data merge. The Project Manager needed a supplier that could lock a single synthesis route, hold inventory against a 6-month forecast, and harmonise the lot-specific data packet across all six site shipments.
Approach
Lyochem's atelier team scoped the campaign at 1.2 kg total across the six sites, ran a single qualification lot at the standard analytical packet, and then released the campaign volume against a forecast-reserved synthesis schedule with a locked route. Every site received its shipment from the same parent batch where possible, and where multiple batches were needed each batch carried a documented lot-to-lot bridging analysis (overlay HPLC chromatograms, mass-spec identity continuity, and a side-by-side stability point comparison). The sponsor QA team received the harmonised data packet at campaign kickoff so the audit trail was in place before the first dose was prepared.
Outcome
Total elapsed time from RFQ to first site shipment: 6 weeks. The 6-month forecast carried the campaign through site rollout without renegotiation; the sponsor QA team accepted the harmonised data packet on first review without back-and-forth on lot-to-lot variance. The cross-site data merge cleared sponsor sign-off on schedule and the CRO has continued using Lyochem against rolling forecast for the follow-on programme.
“Lot-to-lot harmonisation across six sites is a procurement problem, not just a science problem — the sponsor QA team needs the audit trail in their hands before they will accept the data merge. Lyochem's forecast-reserved single-route approach was the difference between a clean campaign and a re-run.”