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.
- 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