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Case Studies

Acquiring a biologic comparator product for a US biotech company

A US Biotech was about to launch a global Phase 3 Oncology study and was struggling with acquiring the Biologic comparator product required for their head-to-head study. Working with another vendor, the sponsor was unable to access the product in the desired quantity and was given a 4-6 month lead-time to procure the product from the US market.

Thanks to the use of our UniQ™ in practice, our client achieved a $2.1m saving on the first-year comparator spend ($6m over the 3-year study). Bionical Emas also provided support on additional documentation to ensure products could be released and imported into the various countries involved in the study (Certificate of Analysis, Certificate of Compliance, GMP Certificate, Batch Release, Manufacturer Equivalency Statement). As a result of Bionical Emas involvement, lead-times were reduced by 4 months compared to the existing route offered by the original vendor and a guarantee was provided by the manufacturer for the duration of the 3-year study.