Client Overview
A leading research institution faced challenges in managing and securing their electronic data capture (EDC) processes. Their existing system lacked compliance with 21 CFR Part 11, making regulatory adherence difficult. They needed a scalable, cloud-based solution that could enhance data security, streamline data entry, and ensure seamless collaboration across multiple research sites.
Challenges
- Regulatory Compliance: The client’s system did not meet FDA and HIPAA standards, posing risks to sensitive research data.
- Data Integrity: The lack of automated validation checks led to inconsistencies and errors.
- Inefficient Workflow: Researchers struggled with a slow, outdated system that hindered productivity.
- Limited Collaboration: Cross-site data sharing was cumbersome, leading to operational bottlenecks.
Solution
Our team implemented a customized EDC SaaS platform designed for compliance-driven research institutions. Key features included:
✅ 21 CFR Part 11 Compliance – Ensured full regulatory adherence with audit trails, e-signatures, and automated validation checks.
✅ Cloud-Based Infrastructure – Enabled real-time collaboration with role-based access control.
✅ Automated Data Migration – Secure transfer of legacy data with error-free validation.
✅ Scalable Licensing Model – Flexible pricing based on usage, reducing upfront investment.
✅ End-to-End Support – Live training, documentation, and 24/7 technical assistance.
Implementation Process
🔹 Phase 1: Consultation & Requirement Gathering – Worked closely with stakeholders to tailor the solution.
🔹 Phase 2: Development & System Configuration – Built custom forms, automated workflows, and compliance features.
🔹 Phase 3: Data Migration & Validation – Ensured smooth transition with data integrity checks.
🔹 Phase 4: Training & Go-Live Support – Provided in-depth onboarding and real-time troubleshooting.
Results
📈 50% Reduction in Data Entry Errors – Automated validation significantly improved accuracy.
📉 40% Faster Research Workflows – Cloud-based system streamlined data collection and analysis.
🔐 100% Compliance with 21 CFR Part 11 – Eliminated regulatory risks and enhanced audit readiness.
💰 Cost Savings on IT Maintenance – Cloud hosting reduced infrastructure costs and downtime.
Conclusion
By partnering with our SaaS solution, the research institution modernized its data management practices, enhanced compliance, and boosted efficiency. Our scalable model ensures they remain at the forefront of innovation without the burden of costly IT overhead.
