Adaptive Trial Processes
The key to successful implementation of an adaptive design trial are processes that enable project management, data management and site monitoring to be tailored to real time learning. These processes need to be integrated with systems that support electronic data capture, dynamic randomization, drug or device supply management, organization and management of Data Monitoring Committees (DMCs), and deployment of operational firewalls that ensure the validity and integrity of the trial at all times.
With a wealth of statistical expertise and design and execution experience, and the leading software platform in the industry, Aptiv Solutions is uniquely positioned to help Sponsor Companies maximize the benefits, and avoid the pitfalls, of adaptive design trials. Utilizing our integrated technology platform (AptivAdvantage™) and operational processes specifically designed for adaptive trials, we adhere to the following principles and working practices to deliver success:
- Ensure maximum protection of the blind character of study data at all levels across data management, statistics, drug supply, and randomization
- Obtain clean data quickly under tight, well-defined deadlines
- Undertake automated statistical analysis
Through the harmonization of technology, processes and people, the facilitation of data driven monitoring and real time data cleaning is made easy, which in turn enables timely database lock at each interim analysis step. 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.