QDRx - Interactive Web-Randomization (IWR)

QDS will implement web-based randomization criteria based upon a SAS PROC plan, which can accept up to 10 stratification criteria. IWR is capable of linking kit numbers to investigational product (IP) shipments, and serves as a check and balance upon subject randomization and IP assignment. Through this link, IP re-supply and inventory are easily tracked and managed.

Dynamic randomization, used in adaptive design studies, is another key feature of QDS’ IWR System which seeks to balance treatment groups across each stratification as well as the overall study.

As subjects are randomized, confirmations are sent to Site Staff to maintain with subject source documentation for easy IP-accountability. Ensuring tight control of the randomization process, the randomization sequence deactivates upon reaching enrollment goals.

When used in tandem with the CTMS, the Study Team will be alerted when a site is short of clinical supplies to ensure a subject is never randomized in the absence of IP.