Specialized Products | Data Monitoring Committees
Cardiac Safety | Project Turnaround | CRO Services
Longitudinal Data Integration
Cardiac Safety
New regulatory requirements have established cardiac safety as an important factor during drug development. These requirements have been accepted globally and have been documented in “Guidance for Industry E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs.” This guidance speaks to the integration of pre-clinical and clinical findings for a cardiac safety assessment, with a focus on cardiac repolarization, a surrogate for the risk of life threatening ventricular arrhythmias. Although there has been a lot of focus on the ‘thorough QT' study in drug development, recent events have highlighted the need for broader cardiac safety and risk management efforts.
ACI offers the following specialized Cardiac Safety services:
- Regulatory Strategy — Preclinical To Phase IV
- Thorough QT Studies
- Protocol Design
- Sample Size To Optimize Validity Within Cost Constraints
- Clinical Monitoring
- Biostatistical Analysis Of Completed Studies
- Final Report
- Cardiac-Specific DMCs
- Cardiac Endpoint Adjudication
- Cardiac Risk Management
