Centralize Cardiac Safety to achieve better data quality, integrate, reduce burden and risk, and lower costs to protect patients and compounds
All new pharmaceutical products must go through comprehensive testing to assess their effect on the electrical functions of patients’ cardiac system before being approved for release to the market. As cardiac safety concerns are the number one reason that drugs are refused regulatory approval or withdrawn from the market, the need for reliable, accurate collection and interpretation of ECG and blood pressure data during the clinical trial process is paramount.
Centralizing cardiac safety with ERT in Phase II-IV trials reduces the burden and risks while lowering overall costs by ensuring standardized ECG equipment and algorithms, consistent training, fewer adept readers, cardiologist and electrophysiologist analysis, and real-time digital access. Centralization results in better data quality and increased protection for patients and compounds. And yet, an estimated 50% of studies still use a decentralized approach.