Efficacy Data Quality Check

Overtime, NJS has provided below proprietary SAS programming tool to check the data quality and derive the primary efficacy endpoints. In Phase I extension or Phase II trials, the investigator response is the primary efficacy endpoints. NJS can derive the response from the raw data to safe guard the accuracy of the derivation. 

The endpoints are:

  • RECIST Data Quality Check and Derivation Check
  • iRECIST Derivation Check
  • Cheson Criteria for AML and Lymphoma
  • PCWG for Prostate Cancer
  • IMWG for Myeloma
  • Myelofibrosis
  • IWCLL for CLL

Other Expertise

E
Therapeutic Area
E
Statistical Methodology
E
Efficacy Data Quality Check
E
Oncology Event Projection
E
Sample Event Projection