Aces

Access Control Execution System

Access Control Execution System (ACES)

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.

Key Features

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

Numerous sponsors have deployed ACES in accordance with their data handling SOPs and regulatory guidance. The Phase 3 VALOR oncology trial is using ACES to facilitate the interim analyses per the adaptive sample size re-estimation design. This ASCO-accepted poster documents VALOR's adaptive design and ACES implementation.

Contact Sales
Schedule Live Demo