Central Laboratory Services for Clinical Trial

Summary

The procurement covers central laboratory services for two phase I/IIa clinical trials investigating bispecific antibody therapy for solid tumours. The studies are planned for 90 participants at five sites in Germany; the project starts in mid-November 2026, the first subject is expected in December 2026, and the study ends in April 2028. The service provider will manage sample receipt and logistics, laboratory kits, blood sample processing, PBMC isolation, serum cytokine analysis, specimen management and long-term storage, as well as data management and reporting. Indicative volumes are approximately 90 kits, 30 inbound and 4 outbound shipments, 360 PBMC specimens, 2,250 cytokine tests and 4,500 managed specimens; at least two cumulative data transfers are required. Specimens are to be stored at −80 °C and/or in liquid nitrogen for approximately 90–720 days, with temperature monitoring and a 24/7 alarm system. The stated serum assay panel comprises TNF-alpha, IFN-gamma, IL-1beta, IL-6 and IL-10; the study-parameters table also lists IL-2. The laboratory must meet GCP/GCLP requirements and be ready to receive specimens by First Subject In. Bids must be submitted in English electronically through DTVP by 11:00 German time on 4 November 2026. Evaluation weights are price 40%, analytical quality and performance concept 35%, and turnaround time and laboratory readiness 25%.