Experience > Registration Trials
CRAB is proud to have provided electronic data capture (EDC), randomization, data management and statistical support for a successful randomized multicenter Phase III trial comparing a new formulation of cytarabine and daunorubicin to the standard regimen in patients with high risk AML. CRAB’s statistical team designed the trial, supported DSMB meetings and provided statistical representation at regulatory meetings at the FDA. Over 300 statistical outputs were generated by CRAB’s statistical team to support the New Drug Application (NDA). Data was submitted in Cinical Data Acquisition Standards Harmonization (CDASH) and Clinical Data Interchange Standards Consortium (CDISC) compliant format.