AptivAdvantage®

AptivAdvantage® the INTEGRATED TECHNOLOGY PLATFORM™ for adaptive trial execution

AptivAdvantage®

Successful implementation of an adaptive design trial requires harmonization of technology, processes and people. Aptiv Advantage integrates project, data and site management to enable real time learning and better decision making.

A Tool for Increased Trial Efficiency

AptivAdvantage is a flexible and seamless platform that connects electronic data capture (EDC), randomization and drug supply management.  Designed to simplify and streamline adaptive trials, it also offers broad application and benefits for traditional, non-adaptive trials.

  • Simplified data driven monitoring
  • Real time data cleaning
  • Faster database lock
  • Real time and dynamic randomization
  • Interactive logistics, supply chain and inventory management
  • Adherence with regulatory requirements to minimize operational bias and maintain trial integrity

Electronic Data Capture (EDC)

With AptivAdvantage, study monitors and data managers have tools as robust as those in a traditional paper Clinical Data Management System (CDMS).

  • A simple, intuitive interface that streamlines study activities for study coordinators and investigator
  • A workflow based dashboard portal provides a real time view of workloads, including incomplete CRFs and outstanding queries
  • A prioritized dashboard to guide users to increase their efficiency and productivity

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 dynamically as the data from previous patients dictate the next randomization. AptivAdvantage provides:

  • An interactive and web-based randomization process, embedded within EDC
  • A “Statistician Interface” to easily develop, simulate and validate even complex randomizations
  • EDC integration to eliminate custom programming between disparate systems, for faster and simpler randomization deployment
  • Emergency unblinding during the course of the trial, without any risk of unblinding stakeholders not involved in the process

Drug Supply/Inventory Control

In an adaptive trial with dynamic randomization, inventory control is supported through a well-connected EDC system. Product supply teams need to know precisely what kits are on site and available for deployment. Aptiv Advantage allows users to:

  • Eliminate the need for nightly batch loads, sFTP exchange and costly, custom built APIs
  • Simplify inventory data exchange using an interactive logistics, supply chain and inventory control management system that fully supports the product supply team
  • Manage depot to depot exchange, supply packing and shipping to sites
  • Use the quarantine/stability interface with clinical supply and sites
  • Track shipments from within the EDC environment

Click to download the AptivAdvantage Whitepaper. (PDF)