Putting Trial Data Insights Into Action For Your Study

By Amanda MacGregor, Product Manager, Strategic Solutions

Maintaining data integrity by ensuring that data are complete, consistent, and accurate is essential throughout every stage of a clinical trial. Recent regulatory guidance not only reinforces the importance of safeguarding data integrity but also emphasizes a proactive, documented approach to how data will be monitored, verified, and maintained over the course of a study. Establishing a comprehensive data monitoring plan is therefore critical, as it provides a structured mechanism to meet regulatory expectations and uphold the credibility and reliability of trial outcomes.

The International Council for Harmonization (ICH) revised its guidance to require clear, documented evidence demonstrating how sponsors conduct ongoing surveillance and oversight of study data. Similarly, the MHRA, FDA, and EMA have issued data integrity guidance that promotes a proactive stance — moving beyond assurance to prevention through robust systems and documentation.

To develop a rigorous data monitoring plan, sponsors must ensure that effective solutions are in place to facilitate systematic data review and verification. In the absence of an integrated eClinical platform, this process may require manual data exports, cross-system checks, and validation activities across multiple tools. Incorporating technology that enables seamless data integration and monitoring can significantly enhance efficiency, reduce risk, and strengthen compliance with evolving regulatory standards.