Application note: Interactive response Technology -An untapped source of historical and real-time data for risk-based monitoring

In this application note, ALMAC discuss the potentially useful source of real-time and historical data…

Risk-based monitoring has attracted the support of a diverse group of organisations in recent years. Regulators have released guidance encouraging the use of risk-based approaches to clinical trial quality, vendors have created technologies to support such methods, and large pharma companies have pooled their resources to drive adoption. Yet, despite this flurry of activity, the industry has overlooked a potentially useful source of real-time and historical data.

In essence, risk-based monitoring is a way for sponsors and CROs to focus their time and resources on the trial activities, data, and sites most critical to the success of the trial and safety of the patients. Instead of treating each site the same, organisations using a risk-based approach can tailor their approach. Communication with clinical investigators, reviews of study centres’ processes, procedures, and records, and Source Data Verification (SDV) activities can be adapted to each site’s past and current performance. The idea is to raise the quality of clinical trials not by doing more monitoring, but by doing smarter, more data-driven monitoring.