The Challenge

• Legacy technology limitations: The organization relied on outdated, in-house systems that lacked the flexibility and scalability required for modern clinical research.

• Integration bottlenecks: Siloed systems created data integrity issues, compliance risks, and hindered holistic trial oversight.

• Operational inefficiencies: High maintenance costs and manual processes slowed down trial setup, management, and monitoring.

• Sponsor pain points: Difficulty in collaborating with vendors and investigator sites due to the absence of a centralized access mechanism.

• Compliance exposure: Technology depreciation compromised the institution's ability to maintain audit-readiness and meet regulatory requirements.

The Solution

• Unified cloud platform: Deployed Cloudbyz's integrated suite including CTMS, CTBM, EDC, and eTMF, all hosted on a centralized cloud infrastructure to eliminate data silos and enhance real-time visibility.
• End-to-end study management: Enabled comprehensive tracking of study setup, milestones, site performance, and budget planning through Cloudbyz CTMS and CTBM.
• Seamless integration: Established robust interfaces with existing systems like Medidata Rave, RSS, Triad, Quic, and Sitecore to unify the clinical data ecosystem.
• Advanced document management: Cloudbyz eTMF centralized trial documents, enabled automated metadata tagging, milestone tracking, and real-time document completeness dashboards.
• Intelligent data capture: Implemented Cloudbyz EDC to streamline eCRF creation, subject tracking, and visit management, enhancing data accuracy and reducing manual workload.
• Enhanced collaboration: Deployed Site & Sponsor Portals to facilitate secure, role-based access for investigators and vendors, improving communication and oversight.
• Regulatory compliance: Ensured alignment with 21 CFR Part 11, GCP, and ALCOA+ standards, making the organization inspection-ready at all times.

The Results

• Improved operational efficiency: Digitization of trial processes led to faster study setup, reduced cycle times, and increased protocol adherence.
• Reduced IT burden: Transition to a cloud-based solution drastically lowered maintenance overheads and future-proofed the infrastructure.
• Enhanced trial visibility: Real-time analytics and dashboards provided key stakeholders with insights into performance, compliance, and budget adherence.
• Streamlined collaboration: Investigator and sponsor portals facilitated easy and secure data sharing, enhancing external stakeholder engagement.
• Integrated ecosystem: Unified data across previously disjointed systems enabled a single source of truth, improving data integrity and decision-making.