Experience > Registration Trials
In 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 is proud to have provided electronic data capture, randomization, data management and statistical support. 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 a Clinical Data Interchange Standards Consortium (CDISC) compliant format.
CRAB also utilizes CDISC standards for the majority of its eCRF design. All eCRFs for registration trials and SWOG trials using a CTEP-held IND comply with CDASH. This format enables greater standardization with other trial data and also allows for more efficient downstream processes related to FDA submission.