The Challenge
Despite its leadership in herbal medicine research, the company faced major clinical trial management inefficiencies due to:
- Disconnected and disparate trial master file (TMF) systems – Lack of integration created confusion and delayed study execution.
- Time-consuming document management – Manual processes made organizing, retrieving, and managing clinical documentation inefficient.
- Limited collaboration & security concerns – Without a centralized platform, ensuring secure data access and version control was difficult.
- Delays in study execution – Inefficient workflows slowed down the process of launching and managing clinical trials.
To streamline trial operations, improve compliance, and accelerate research, the company needed a modern, cloud-based solution to integrate clinical trial data, automate workflows, and ensure seamless document management.
The Solution
To overcome these challenges, the company partnered with Cloudbyz to implement a fully customized Clinical Trial Management System (CTMS) and eTMF solution. This cloud-based transformation provided:
- A centralized platform for clinical trial data – All documentation, study management, and reporting were integrated into a single, secure system.
- Automated eTMF management – Study teams could create DIA-modeled folders with a single click, eliminating manual folder creation.
- Custom workflows & automation – Automated budget tracking, site management, and reporting improved trial efficiency.
- Granular access control & security – User-based permissions ensured only authorized personnel could access trial-related data.
- Seamless collaboration – Internal and external stakeholders could access real-time study updates, improving coordination.
With Cloudbyz CTMS and eTMF, the company gained an efficient, compliant, and scalable solution, positioning itself for faster trial execution and improved data management.
The Result
With Cloudbyz’s cloud-based CTMS and eTMF solutions, the company achieved greater operational efficiency, compliance, and scalability in clinical trial management. Additional key benefits included:
- Faster Trial Execution – Automating study setup, documentation workflows, and approvals reduced time spent on administrative tasks, accelerating clinical research timelines.
- Elimination of Data Silos – A single, unified system provided a centralized repository for all clinical trial data, ensuring seamless data retrieval, tracking, and reporting.
- Improved Regulatory Compliance – With automated audit trails, version tracking, and role-based access controls, the company ensured compliance with FDA, GCP, and DIA standards.
- Greater Data Security & Access Control – The granular permission settings in eTMF safeguarded sensitive trial data, ensuring that only authorized personnel had access to critical files.
- Enhanced Collaboration Across Sites – Investigators, sponsors, and study teams could work together in real-time, accessing up-to-date trial documents and study progress reports from anywhere.
- Significant Cost Savings – Digitizing workflows reduced paper-based processes and manual inefficiencies, lowering operational and administrative costs while improving productivity.
By transitioning to Cloudbyz’s digital ecosystem, the company streamlined its clinical trial processes, enhanced regulatory compliance, and improved trial execution speed—ultimately positioning itself as a leader in herbal medicine research and innovation.
