How a Leading Research Institute is Driving Clinical Excellence with Cloudbyz’s Integrated eClinical Platform

CTBM
Oncology research institute-1

Industry

Life Sciences

Challenge

Outdated legacy systems with poor integration, high maintenance costs, and lack of centralized oversight

Results

Improved trial efficiency, enhanced compliance, streamlined data management, and reduced operational costs

Key Products

CTMS, eTMF, CTBM, EDC

clinical trials in radiology need a image for the clinical trial happening

About your Customer

Founded in 1923, this academic research institution based in the United States, has been a pillar in medical imaging and radiology, representing more than 41,000 diagnostic and interventional radiologists, radiation oncologists, nuclear medicine physicians and medical physicists. With a century-long legacy, it operates within the strict regulatory purview of the U.S. FDA and adheres to global compliance standards including GCP and ICH guidelines.

The organization manages a vast array of clinical studies across various therapeutic areas, with a focus on radiological and imaging-based research. Operating in a dynamic regulatory and scientific landscape, it faced the pressing need to modernize its clinical trial infrastructure to match its ambitious research agenda.

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  • Legacy technology limitations: The organization relied on outdated, in-house systems that lacked the flexibility and scalability required for modern clinical research.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

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