FLeX IWRS 9843b

 

Embedded on-line randomization

 

The randomization of patients to a treatment group is a critical component of a randomized clinical trial.

Lambda-Plus Interactive Web Response System (IWRS) - FLeX+ IWRS - provides convenient, real-time, secure, confidential access to a centralized study database to help manage this process.

Lambda-Plus e-Platforms integrating IWRS increase the accuracy, efficiency, and cost savings of conducting clinical trials using one system.

Study site staff seamlessly access the IWRS module through a secure e-Platform for on-line randomization.

 

Key Features

  • Cost-effective and user-friendly solution
  • IWR accessed 24/7 from anywhere
  • ICH GCP and FDA 21 CFR part 11 compliant
  • Confirmation of treatment allocation by e-mail/fax
  • Seamless management of the unblinding process
  • Full interaction between sites, CRO and sponsor
  • Date- and time-stamped data
  • Real-time access to study database
  • Multi-language capability
  • Randomization result possibly coupled with drug supply management