Regulatory authorities are increasingly interested in 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.
To help clients meet the growing demands for verified endpoint data, our experienced thought leaders and seasoned endpoint team manages the full adjudication process. Aptiv Solutions can be involved in everything from development of standard and clinically reasonable definitions to charter development, timely endpoint package field management and sophisticated status report and impact analysis. We have also developed processes to ensure that events will be devoid of reviewer bias and/or cultural differences.
- Efficient endpoint processing center
- Technology platforms for endpoint management of drug, device & biologic studies
- CEC & IRC management, including iDMC interface
- Development of protocol language
- Trained & industry-experienced committee members
- Reconciliation across the clinical, safety & endpoint databases