AptivAdvantage™ the INTEGRATED TECHNOLOGY PLATFORM™ for adaptive trial execution
The key to successful implementation of an adaptive design trial is the harmonization of technology, processes and people to allow project management, data management and site monitoring to be tailored to real time learning.
AptivAdvantage™, is designed specifically for adaptive clinical trials to allow these processes to be integrated in a flexible and seamless environment that incorporates electronic data capture (EDC), randomization and drug supply management.
The result is the facilitation of data driven monitoring and real time data cleaning, which enables timely database lock. These are critical features for the effective execution of adaptive trials and are specifically designed to meet regulatory agency requirements to minimize operational bias and maintain trial integrity.
Electronic Data Capture (EDC)
AptivAdvantage™ provides tools to study monitors and data managers that are as robust as those found in a traditional paper Clinical Data Management System (CDMS). It also provides a simple and intuitive interface that streamlines the user experience for study coordinators and investigators. A workflow based dashboard portal provides users with a real-time view of their workload, including CRFs that need to be completed and outstanding queries. The dashboard facilitates productivity by guiding the user to the areas of most importance.
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.
A Tool to Improve Trial Efficiency
AptivAdvantage™ provides a robust platform for building efficiency into the clinical trial process and, while it has been designed for adaptive trials, it also has broad application in non-adaptive conventional trials.