The Challenge

• Complex sponsor requirements: Required a CTMS adaptable to the diverse study needs of multiple sponsors across global regions.

• System silos and inefficiencies: Utilized a mix of EDCs, eTMFs, and analytics tools that lacked interoperability, resulting in manual reconciliation and data inconsistency.

• Lag in system responsiveness: The legacy CTMS caused delays in implementing changes or enhancements due to outdated infrastructure.

• Limited oversight: Teams struggled with inconsistent site feasibility and document tracking processes, resulting in inefficient site activation and monitoring.

• DCT trial management gaps: Growing decentralized trial models needed mobile-friendly access and visit tracking functionalities to maintain protocol adherence.

The Solution

• Configurable CTMS platform: Cloudbyz CTMS was tailored to the customer’s operational model using Salesforce’s flexibility to accommodate diverse sponsor and protocol workflows.

• Investigator and Sponsor Portals: Deployed role-based access portals with automated approval and document review workflows, improving cross-functional visibility.

• Seamless integrations: Integrated with existing systems including Medidata, Veeva, Zelta EDCs, and Veeva Vault eTMF through open APIs, allowing subject and document data synchronization.

• Advanced features deployed: Leveraged feasibility surveys, essential document checklists with eSignature, eDOA logs, budget management with planned vs actual financials, and centralized reporting.

• DCT enablement: Implemented Cloudbyz DCT components such as eSource, eConsent, and Visit Window Projection, along with Salesforce One mobile access, empowering clinicians to conduct remote and mobile site data entry.

The Results

• Reduced operational lag: Real-time subject and site updates via integrated EDC and eTMF systems eliminated data duplication and expedited decision-making.

• Improved efficiency: Achieved a 50% reduction in turnaround time for MVRs and clinical reporting via standardized templates and automated workflows.

• Enhanced site activation: Auto-assigning milestones and site creation upon feasibility approvals improved site onboarding efficiency.

• Increased study visibility: Dashboards and dynamic reports offered centralized monitoring of study progress, training, and budget metrics across global units.

• DCT readiness: Clinicians used mobile interfaces for real-time CRF entry, while eConsent and visit projections supported remote patient interactions and adherence tracking.