How TrialPal MOVI Reduces Errors and Ensures 21 CFR Part 11 Compliance in Clinical Trial Monitoring
In modern clinical trials, monitoring visits are critical for ensuring data integrity and participant safety. Yet many contract research associates (CRAs) still rely on paper-based processes or non-validated tools, increasing the risk of errors, delays, and compliance violations. TrialPal MOVI is a validated digital platform for clinical trial monitoring, designed in accordance with FDA 21 CFR Part 11. It enables complete electronic source (eSource) monitoring, remote access, and real-time oversight, with the traceability, speed, and automation that today’s studies demand.
The Problem: Manual Monitoring = Risk
Clinical trial sites using manual or hybrid methods face well-known challenges:
- Data loss during transport or storage of paper files.
- Undetected discrepancies in source data verification (SDV).
- Delayed report approvals due to manual review of workflows.
- Non-compliance with audit trail and access control requirements.
These gaps can affect regulatory readiness, lead to protocol deviations, and increase operational costs.
The Solution: TrialPal MOVI — Clinical Trial Monitoring Software That Delivers
TrialPal MOVI simplifies the CRA’s workflow and accelerates clinical oversight by offering:
- Digital report creation and e-signatures — record deviations, findings, and action items in minutes.
- Complete traceability — track each step, from scheduling to sponsor sign-off.
- Built-in compliance — audit trail, access control, and eSignatures per 21 CFR Part 11 and GCP standards.
- Secure remote monitoring — access reports from any device, anywhere.
- Real-time dashboards — monitor report status, trends, and team performance.
Real-World Impact: From Paper to Digital in a Multicenter Study
In a multicenter vaccine trial, CRAs were using paper forms and encountered these issues:
- High site variability — some centers still fully paper-based.
- 2 out of 5 CRAs reported data loss due to document misplacement.
- Up to 4-week delays in sponsor report approvals.
With TrialPal MOVI, we implemented:
- Secure, cloud-based access for all CRAs.
- Digital forms with real-time validation and field controls.
- Role-based review workflows:
- CRAs complete visit forms directly in the platform.
- Project Managers (PMs) review and approve, with comment tracking and version control.
- Audit-ready dashboards for visibility into monitoring KPIs.
- Dual signature options: electronic or wet ink, aligned with local requirements.
Results After Implementation
Zero data loss during monitoring visits.
Report approval time cut from weeks to hours.
Improved traceability between CRA and PM roles, minimizing contextual errors.
Regulatory compliance confirmed in multiple audits.
Why Sponsors and CROs Choose TrialPal MOVI
TrialPal MOVI helps CROs and sponsors improve the accuracy, speed, and compliance of their monitoring processes:
- Enables remote monitoring across global sites
- Replaces outdated paper-based monitoring tools
- Improves CRA productivity and documentation quality
- Ensures readiness for regulatory inspections
