Case study ONCOLOGY CASE A randomized, double-blind, placebo-controlled multicenter study of efficacy and safety of the drug product. Therapeutic area: oncology, colorectal cancer. Data MATRIX provided a full service support for the standard phase III study of high complexity. Complicated randomization strategy: blocked randomization, 3 treatment groups; stratification by presence of neutropenia at the time of enrollment into the study. Tumor growth assessment performed by a central assessor. IWRS is programmed in accordance with the requirements of the Protocol. An “Independent Assessor” role is added to the MATRIX EDC/IWRS: the user may only see the results of tumor measurement and add findings of tumor assessment to CRF. Forms to be filled out by the Independent Assessor have l

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