IWRS

Randomization

Adaptive trials require robust yet flexible randomization engines that can adjust mid study (i.e. dropping a treatment arm or increasing a dose) or even dynamically as the data from previous patients dictate the next randomization. Embedded within the EDC component of AptivAdvantage® is a truly interactive and web based randomization process. The system also offers a ‘statistician interface’ that allows the development, simulation and validation of even the most complex randomizations. Because it is utilizing the same database as the EDC system, AptivAdvantage reduces time to deployment by avoiding custom programming to integrate disparate systems. Any emergency unblinding during the course of the trial is supported by AptivAdvantage without any risk of unblinding stakeholders not involved in the process.

Drug Supply/Inventory Control

In an adaptive trial with dynamic randomization, inventory control needs to be accessible to EDC at all times. The system must know precisely what kits are on site and available for deployment. In the past, data technologists were required to facilitate this data exchange via nightly batch loads, sFTP exchange and, in the case of the ambitious, custom built Application Programming Interfaces. AptivAdvantage takes inventory control takes to the next level by creating an environment specifically for the product supply team that constitutes an interactive logistics, supply chain and inventory control management system. The system allows depot to depot exchange, supply packing and shipping to sites and a quarantine/stability interface with clinical supply and site. Investigators are also able to track shipments from within the EDC environment.