Customer Challenge

A federal agency needed to establish a centralized, standardized data infrastructure to advance vascularized composite allotransplantation (VCA). Challenges such as small patient populations, inconsistent outcome reporting, and complex treatment protocols hindered both research and clinical progress. The agency sought a collaborative framework to unify patient registries, harmonize study standards, and enable secure, national data sharing a foundation critical to strengthening clinical decision-making, informing policy, and accelerating VCA's recognition as a standard of care.

Navitas Solution

Navitas developed CONSORT VCA-NET, a decentralized Clinical Trial Management System (eCTMS) tailored to the clinical and data integration demands of hand and face reconstructive transplantation. Our secure, web-based platform streamlines critical trial workflows, enforces consistent outcome reporting, and validates the technical and operational feasibility for a future national VCA registry. This foundation enables harmonized data collection, seamless cross-site collaboration, and a robust evidence base to assess long-term safety and effectiveness of VCA procedures.

To achieve these outcomes, Navitas designed the solution around eight consensus-driven pillars: Patient Inclusion/Exclusion Criteria, Patient Education, Surgical Procedures, Immunosuppression, Outcome Metrics, Quality of Life, Rehabilitation, and Data Reporting. The platform integrates AI-powered analytics for predictive modeling, benchmarking, and advanced clinical decision support accelerating the adoption of VCA as a standard of care.

We delivered the program end-to-end, leveraging data engineering, model development, and multidisciplinary stakeholder engagement. Our team led structured workshops to define standardized practices, governance models, and consensus across the eight focus areas. Using Agile methodologies, we iteratively launched features with continuous validation to ensure sustained alignment with clinical priorities and mission requirements.

Results

• Multiple clinical applications and registries unified within the platform, supporting diverse vascularized composite allotransplantation (VCA) studies.
• 25% reduction in manual data collection effort, resulting in significant time savings for clinical and research teams.
• 45% boost in data accuracy, enabling more reliable outcome reporting and benchmarking.
• 25% improvement in operational efficiency and collaboration across participating research centers, driven by standardized workflows and automated reporting.
• Accelerated adoption of VCA as a standard of care by enabling evidence-based decision-making and streamlined governance through AI-powered analytics and automated processes.