Contract Research Organization (CRO) services contract

Summary

FIBAO is procuring the integrated services of a Contract Research Organization (CRO) for a multicentre, randomized, double-blind, placebo-controlled clinical trial of ruxolitinib cream for atopic dermatitis affecting the hands, feet and eyelids. The study is planned for five hospitals and approximately 64 patients. The services include study start-up and documentation, electronic data-capture system development and support, regulatory submissions, monitoring, project management, pharmacovigilance, data management and biostatistics. The contract is not divided into lots and is expected to last 30 months, with a possible extension up to a maximum of 60 months.