Data Capture Software for Compliant Psychotherapy Trials
Product Overview
Client’s goals
To meet the client’s needs, Jelvix designed a solution that balanced affordability, compliance, and scalability.
The psychotherapy research group approached Jelvix with five clear goals:
1. Select an open-source EDC platform that fits current pilot trials and supports long-term expansion.
2. Deploy securely on AWS or Azure with HIPAA-compliant cloud architecture.
3. Implement strong security and compliance measures, including encryption, audit logs, and access control.
4. Integrate workflows for trial management, such as CRF setup, patient enrollment, and e-signatures.
5. Provide long-term monitoring and support to keep their EDC system audit-ready for regulators.
Implementation
Turning the client’s goals into a real solution took a clear, step-by-step plan. Jelvix specialists guided the project from the early feasibility study through to full deployment, making sure the system met compliance standards and fit smoothly into daily research workflows. Their proven experience in AI software development and healthcare integrations helped align the platform with modern standards and prepare it for future research expansion.
Step 1. Discovery and Cost Analysis
Jelvix business analysts began with a comprehensive workflow review to define how an EDC in clinical research should support psychotherapy research. They analyzed trial protocols, user roles, and data management requirements. Cost modeling for AWS and Azure helped the client understand long-term operational expenses.
Step 2. Feasibility Assessment
The team compared three open-source platforms (OpenClinica, LibreClinica, and REDCap) to determine which one best matched the client’s needs. After weighing compliance capabilities, community support, and scalability, REDCap emerged as the strongest option. Its proven use in academic research and flexibility for multi-site studies made it the most reliable choice.
Step 3. Pilot Implementation
To test the approach, Jelvix set up a pilot on AWS that replicated a live trial environment. This allowed the client to see how the system would perform in practice. During this phase, encryption, role-based access, audit logging, and compliance with HIPAA and CFR 21 Part 11 were all validated. Researchers also worked with customized Case Report Forms (CRFs) and confirmed that the platform aligned with their study workflows.
Step 4. Full Production Deployment
With the pilot complete, the team moved to full deployment on AWS/Azure. The platform launched with secure logins, permission controls, and real-time encrypted data capture. Audit trails and e-signatures ensured compliance, while workflows for enrollment, monitoring, and reporting were integrated directly into daily operations. Careful planning meant the rollout did not disrupt ongoing studies, and researchers could continue their work while smoothly transitioning to the new system.
Step 5. Ongoing Support
Jelvix DevOps and compliance specialists continue to provide updates, monitoring, and security audits. The system remains inspection-ready for regulators and adaptable to new trials.
Value Delivered
Beyond meeting technical requirements, the new EDC system created measurable advantages for the client.
Affordability with Long-Term Cost Transparency
By implementing an open-source platform like REDCap, Jelvix eliminated the need for annual licensing costs that can reach thousands of dollars with commercial vendors. Instead of paying per-user fees, the client invested only in cloud hosting and customization, both of which scale predictably as trials grow.
This shift freed up over 60% of the budget previously allocated for software and allowed funds to be redirected toward patient recruitment, therapy delivery, and future study design. The cost modeling performed during discovery also gave the client a clear projection of AWS/Azure expenses, making long-term financial planning more reliable.
Regulatory Compliance Embedded Into the Workflow
Rather than treating compliance as an afterthought, Jelvix designed the platform so that HIPAA and CFR 21 Part 11 requirements are enforced at every step of trial management. Audit trails automatically record every data entry, update, and system access, giving researchers full traceability. Role-based access allows only authorized users to view or edit sensitive information, while electronic signatures support legally valid approvals.
By building these controls directly into the platform, the research team gained the confidence to launch trials without worrying about costly compliance gaps or delays during inspections.
Operational Efficiency Through Digitization
The previous manual processes often required multiple reviews, leading to errors and inconsistencies in trial records. With Jelvix’s EDC system, researchers now manage patient enrollment, CRF completion, and monitoring electronically. Automated data checks reduce transcription mistakes, while integrated reporting tools shorten the time required to prepare study updates.
What previously took weeks to compile can now be generated in real time. This efficiency not only reduces staff workload but also improves data quality, which is critical for psychotherapy studies where regulatory scrutiny is high.
Scalability for Multi-Site Expansion
The solution’s cloud-native design allows the client to scale from single-site pilot trials to multi-site national studies without major reconfiguration. Data remains consistent across locations, with central control over user access and monitoring.
This flexibility ensures that as the research team secures additional funding or partnerships, the digital infrastructure will not become a bottleneck. In practice, this means that opening a new study site involves only creating new user roles and extending permissions, avoiding months of redevelopment and reducing costs typically associated with commercial electronic data capture in clinical trials.
Sustainability and Long-Term Support
For a small academic group without dedicated IT staff, sustainability was a top concern. Jelvix addressed this by delivering not just a platform but also ongoing managed services. DevOps engineers continuously monitor performance, compliance specialists run regular audits, and support teams provide quick resolution for technical issues. This proactive approach ensures the platform remains secure, up to date, and audit-ready.
As regulations evolve or trial protocols change, Jelvix adapts the system without interrupting ongoing studies, giving the client a reliable long-term partner in digital research infrastructure.
Project Results
The partnership with Jelvix transformed the way US Psychotherapy conducts EDC clinical trials, delivering measurable improvements in cost efficiency, compliance, scalability, and operational performance.
60% lower costs compared to commercial EDC platforms
By selecting REDCap instead of commercial platforms such as Medidata or Oracle Clinical, the client cut licensing and support costs by more than half. These savings were not limited to the initial rollout but created a lasting financial benefit. With lower ongoing expenses, the research group was able to redirect funds into patient recruitment, therapy programs, and the development of new trial phases.
The transparent cost modeling provided by Jelvix also gave the group long-term financial predictability, an essential factor for academic organizations working with grants.
HIPAA and CFR 21 compliance validated from day one
Compliance is the most critical factor in psychotherapy trials. The deployed platform passed internal audits confirming that encryption, audit trails, role-based access, and e-signatures all met HIPAA and CFR 21 Part 11 standards.
For the client, this means no delays during inspections and no risk of data integrity violations that could jeopardize trial approval. Instead of dedicating staff to manual oversight, the platform automatically enforces compliance in daily operations, ensuring reliable electronic data capture.
Trial setup reduced from weeks to days
Previously, preparing a new study required manual CRF design, paper documentation, and repeated compliance checks, often delaying trial launches by several weeks. With the new EDC, researchers can configure enrollment forms, workflows, and monitoring tools in a matter of days. This agility allows the group to respond quickly to funding opportunities or new study protocols, maximizing their competitiveness in the field of psychotherapy research.
Scalable architecture ready for multi-site expansion
The cloud-native design ensures that scaling trials across multiple research sites does not require major redevelopment. When the client adds a new site, administrators simply define new user roles and permissions, while data remains centralized and consistent. This capability removes one of the largest barriers to growth, enabling the organization to plan nationwide psychotherapy studies without worrying about IT infrastructure.
Error reduction and improved workflows
The shift from paper-based or fragmented digital tools to a centralized EDC in clinical research significantly reduced transcription errors and inconsistencies. Case Report Forms (CRFs) are now validated automatically, while electronic signatures guarantee that approvals are securely logged.
Reporting tools provide real-time visibility into study progress, reducing the administrative burden on staff. These changes improve data quality and reliability, which is particularly important for psychotherapy research where outcomes are often scrutinized closely by regulators and funding agencies.
