Advanced Project Management

Advanced Project Management

Through the use of AptivAdvantage® integrated software, our experienced CRAs and Project Managers provide advanced trial management based on fast, actionable performance metrics that enable flexible project management.

AptivAdvantage®

AptivAdvantage is essential to enable the continuous collection of information to allow actionable data, made available to the right people at the right time.

Coordination of Data and Study Activities

Successful project management involves a coordination of activities and data. The CRA encourages investigators to enter available data and to solve queries in a timely manner. This assures that verified and clean data are available in time for the interim analysis. The Project Manager ensures that all key elements necessary to perform an adaptive clinical trial are available on time.

These include:

  • Integrated IT platform (AptivAdvantage), CTMS and automation for running interim analyses
  • Training of team members (study-specific adaptive customization)
  • Training of site staff by CRAs
  • DMC member list and signed contract with each DMC member
  • DMC charter signed by all DMC members, constitutional DMC meeting and schedule for future DMC meetings
  • Tracking of site performance during recruitment
  • Tracking of timelines for data availability
  • Statistical Analysis Plan for interim analysis
  • Interim Analysis report to DMC
  • DMC recommendation to Sponsor
  • Written notification from the Sponsor regarding the adaptation decision
  • Implementation of the adaptation decision
  • Seamless trial continuation without any change, stop or break