Quality Commitment

Quality Commitment

Focused on IRT, focused on quality

As IRT specialists, we know clinical trials have many risks that need to be mitigated throughout the life of the trial. Simply put, we ensure patients are randomized into the right treatment group and receive the correct medication on time, every time.

The Cenduit Quality System maintains a sharp focus on the quality of the IRT. Cenduit’s global Quality System promotes consistent, compliant delivery of our IRT-driven services and the successful management of your clinical trial throughout requirements gathering, development, testing, User Acceptance Testing (UAT), deployment, and especially maintenance.

Cenduit Quality Delivery includes:

  • Automated study checks that constantly monitor your trial, on each study database, to verify ongoing alignment with the statistical and dispensing rule requirements of the clinical protocol
  • Close collaboration with the clinical and supply chain PMs means Cenduit offers assurance that the treatment balance, associated material kit quantities, and material type IDs and configuration are consistent between all groups and match the protocol requirements
  • Strategic Risk Management Committee (SRMC) Oversight Composed of senior level staff who evaluate circumstances that require risk-based consideration
  • Strong procedural controls are in place to drive quality, consistency, and repeatability throughout all phases of the study software development lifecycle: Requirements, Development, Testing, UAT, Release and Maintenance through to Study Close Out
  • Early detection opportunities to minimize errors in later phases: Unit Testing, Test Dry-Run, System Quality Review (SQR) are followed by a full System Demo and Client System Review to eliminate any surprises prior to validation and User Acceptance Testing (UAT).
  • Risk-based validation strategies employed to seek efficiencies with standard functionality while ensuring mitigation approach for higher risk areas along with a well-defined escalation process for unusually high-risk areas or complexities.
  • Effective and efficient change control process once the study is live. Our modular design and clear specification process enable clients to rapidly implement system changes to reflect protocol amendments or modifications to the supply chain strategy. Quality controls also maintain strict standards for any documented data changes or updates.
  • Strict data controls maintain not only the accuracy and timeliness of all data transfers, exports and reports, but also ensure that the study blind is fully protected at all times.
  • “Gates” defined at key points in the lifecycle to enforce sequencing of events, ensure convergence of activities, and resolve open items