Monitoring visits in clinical trials are essential to ensuring data quality, patient safety, and regulatory compliance. However, many organizations still rely on paper-based processes to capture and manage critical information, leading to delays, errors, and high operational costs.
With increasingly strict regulations and growing pressure to accelerate study timelines, this paper-based model is no longer sustainable.
The Problem with Paper in Data Capture
Paper-based monitoring visits increase costs and pose a direct risk to the integrity of clinical trial data. Some of the most common errors include:
- Delays in consolidating and submitting monitoring reports.
- Difficulty maintaining compliance with FDA 21 CFR Part 11 and ICH-GCP.
- Risk of lost, duplicated, or inconsistent data.
- Limited real-time visibility for sponsors and CROs.
- High costs related to printing, storage, and document transportation.
According to the FDA and EMA, poor documentation remains one of the leading causes of regulatory inspection findings.
TrialPal Movi: Digitalization and Efficiency in Clinical Trial Monitoring
TrialPal Movi is a multi-study digital solution transforming paper-based monitoring visits into 100% electronic, auditable processes. CRAs can record information directly on electronic devices and generate validated, customizable eMonitoring Visit Reports (eMVRs) that comply with international standards.
Key features include
- Electronic, validated recording of monitoring visits.
- Cross-study module for Deviations, Informed Consents, and Action Items—ensuring continuous oversight.
- Real-time dashboards that enable remote monitoring aligned with Risk-Based Monitoring (RBM) practices.
Benefit for Sponsors and CROs
By adopting TrialPal Movi, sponsors, CROs, and research sites can immediately gain:
- Greater efficiency in data collection and analysis.
- Simplified audits and complete transparency through digital traceability.
- Reduced operational costs and eliminated paper dependency.
- Guaranteed compliance with global regulations (FDA, EMA, ICH-GCP).
- Flexibility to scale across global, multi-site studies.
The Future of Clinical Trial Monitoring is Digital
The clinical research industry is rapidly moving toward digital transformation—paperless, interoperable, automated processes that support real-time remote monitoring.
With TrialPal Movi, sponsors and CROs can ensure inspection readiness and accelerate study execution while improving data quality and patient safety.
Book a demo today
References
- U.S. Food and Drug Administration (FDA). Clinical Investigator Inspections. 2023.
- European Medicines Agency (EMA). Good Clinical Practice (ICH E6).
- TransCelerate BioPharma. Risk-Based Monitoring Methodology. 2022.
