Genius IWRS™- Treatment Allocation
Randomization is fundamental to clinical trials—It prevents the selection bias and insures against the accidental bias. It produces the comparable groups and eliminates the source of bias in treatment assignments.
Genius IWRS™ is a web-based application, seamlessly integrated with Genius EDC and Genius DSM™, reducing the need or completely eliminating traditional telephone-based randomization systems. Our expert biostatisticians and IWRS programmers provide fixed, dynamic, multi-stage and adaptive randomization methods.
Genius IWRS™ provides
- Complete Subject Enrollment Tracking (screening through end of study)
- Real-time team notifications
- Eligibility and screening visit enforcement
- Subject Randomization
- Block-based or centrally managed with multiple stratifications
- Study’s custom randomization algorithm
- Global access by authorized clinical site personnel 24/7
- Emergency/Pharmacovigilance code breaks
- Connection with external tools (DSM, eCRF, CTMS)
- 21 CFR Part 11 Compliance