Regulatory authorities are increasingly holding sponsors accountable for the demonstration of proper safety management and classification of simple and composite morbidity and mortality endpoints as either primary or secondary endpoints. The FDA and EMA now recommend centralized endpoint adjudication to assess unacceptable cardiovascular risk of new anti-diabetic drugs. Similar guidelines for drugs and medical devices in other therapeutic areas will follow.
Aptiv Solutions provides experienced staff and technology to fully manage and streamline the complete endpoint adjudication process. Our experts support all aspects of the process from development of standard and clinically relevant definitions, through charter development, to timely endpoint package field management and sophisticated status reports and study impact analyses. Aptiv Solutions offers:
- A highly experienced endpoint coordination team consisting of qualified clinical research medical personnel to collect and process endpoints, and provide consistent and ongoing communication with the project team
- A global team solely dedicated to endpoint processing
- AptivEndpointTM – an integrated technology platform for endpoint management of drug, biologic and medical device studies providing centralized real-time access to study information for sites, investigators, CEC and the sponsor
- Clinical Endpoint Committee (CEC) management including electronic adjudication decisions
- Access to trained and industry-experienced committee members
- Management of translation vendors
- Reconciliation across the clinical, safety and endpoint databases
AptivEndpointTM is a CFR 21 Part 11 compliant application that handles the complex logistics of endpoint management. Users can efficiently manage the endpoint dossier through its lifecycle, from clinical site through CEC, to clinical database, significantly reducing timelines and cost for adjudication services.
- Integrated system with firewalled workflows for sponsors, sites, investigators, and CEC members
- Compliant data transfer procedures for collection, assembly and dissemination of standardized endpoint dossiers
- Efficient site and data query paths
- Accurate delivery of adjudication data
- Workflow tracking dashboards for sponsors and project managers
- Delivery of a robust audit trail