A Single Front-End For EDC and Randomization

Full integration between EDC and IRT system

IRT system In a double-blind randomized placebo-controlled Phase II study, IDDI set up a complete integration between its EDC  system (ID-base™ powered by XClinical) and its IRT system (ID-net). This was a single front-end for the site. Full integration means that the randomization is performed by the site using the EDC system, which calls in the background ID-net randomization web services to perform randomization and treatment allocation. The investigator could therefore randomize patients directly from the EDC system without using the randomization system (ID-net).
In this study, a huge number of subjects had to be screened to ensure a total of 200 fully eligible subjects for treatment. IDDI decided to set up two instances in the EDC system, one for the automatic upload of the data coming from the pre-screened subjects and the other instance for the data collection of the eligible and randomized subjects. This particular set up meant a huge save of time in the study conduct.