Cytel - Access Control Execution System (ACES) Software
The use of independent Data Monitoring Committees (DMCs) for clinical trials has grown dramatically across all therapeutic areas. As such practice continues to expand, sponsors face increased pressure to form committees that ensure adherence to charters, study protocols and regulatory requirements. ACES provides support to DMCs by offering a web-based trial workflow and document management system. Trial sponsors use ACES to comply with regulatory guidance, and to communicate in a secure environment about interim data and recommendations made by the DMC/DSMB, Independent Statistical Center and the clinical team.
- Integrates trial implementation components including statistical design, analysis plan, data collection (EDC, IxRS), and drug supply.
- Constructs firewalls protecting data from inappropriate access
- Forms information paths for sponsor and DMC communications
- Reduces potential for operational biases to be introduced during interim analyses for safety monitoring and/or adaptive design
- Generates supporting documents, including statistical, operational reports