The Challenge

• Disparate systems: Separate vendors for EDC and safety led to lack of data synchronization, impeding decision-making.
• Limited stakeholder collaboration: Lack of centralized portals hindered real-time access and coordination with vendors and investigator sites.

• Legacy eTMF system limitations: Document fragmentation and manual tracking created inefficiencies, making audit readiness difficult.

• Manual data entry and oversight gaps: Inefficient workflows caused delays in tracking milestones, budgets, and compliance metrics.

The Solution

• Centralized Trial Oversight via CTMS: Enabled protocol tracking, milestone planning, CRA visit scheduling, and site management in one dashboard with full audit trails and role-based access.
• Budget Accuracy and Control with CTBM: Provided a structured approach to budget planning with study and site-specific templates, ensuring precise financial tracking and improved resource allocation.
• Streamlined Document Management through eTMF: Migrated thousands of legacy documents into Cloudbyz eTMF. Introduced real-time document tracking, metadata tagging, DIA TMF Reference Model mapping, and inspection readiness dashboards.
• Simplified Data Collection via EDC: Implemented form-based, rules-driven eCRF creation for reliable data collection, supporting real-time subject tracking and visit management.
• Enhanced Collaboration with Investigator and Vendor Portals: Integrated portals facilitated controlled third-party access, improving communication, document exchange, and compliance.
• Salesforce Native Platform Advantage: Provided a secure, scalable foundation with seamless integration across modules and intuitive user experiences.

The Results

• Audit Readiness Achieved: The eTMF overhaul delivered a compliance-ready document ecosystem, drastically reducing preparation time for audits.

• Operational Efficiency Improved: Automating CTMS processes like monitoring and milestone tracking allowed clinical teams to focus on strategic tasks, saving significant time and effort.

• Visibility Across Trials: Real-time dashboards offered complete transparency into site performance, enrollment progress, and budget status, supporting proactive management.

• Streamlined Collaboration: Portals for investigators and vendors eliminated the need for back-and-forth communications, enabling efficient document and data sharing.

• Unified System Benefits: By consolidating systems into a single platform, the sponsor eliminated data silos and improved overall trial agility and responsiveness.