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tsClinical DDworks21 Global

Enhance the Quality and Visualization of Global Clinical Trials without Compromising Good Clinical Practice (GCP) Compliance.

As clinical trials expand to be conducted on a global scale, countless problems arise, particularly:

  • The probability of GCP regulation violation and/or deviation increases
  • Variation in quality from region to region, creating difficulties when managing CROs.
  • Reporting becomes time consuming since formatting varies by region
  • Inefficient paper-based systems inevitably lead to a tremendous amounts of wasted effort when sponsor management and tracking of TMF documents is required
  • The status of TMF documents is impossible to confirm in a timely manner
  • Systems used to manage overseas supply vendors are often hard to implement and use

Streamline and Accelerate Clinical Trials with the DDworks21 Global Software Solution

Fujitsu's DDworks21 Global is a software package designed to ensure that clinical trials are conducted according to GCP guidelines and are enabled to provide accurate and real-time reporting of clinical trial status. The solution is specifically engineered to enhance visualization of global clinical trials and standardize and streamline operations. DDworks21 Global helps reduce risks and provides assurance of the quality of clinical trials regardless of region, while also proving to third parties that clinical trial processes are consistently properly conducted.

Ensure GCP Compliance with DDworks21 Global

DDworks21 Global performs appropriate and comprehensive monitoring of clinical trials-and complies with country-specific and regulations and requirements for clinical trials-by defining a monitoring visit checklist for each clinical trial/country. The solution accurately records and tracks violations of regulations and support so that corrective actions can be taken as needed. DDworks21 Global provides all stakeholders associated with the clinical trials a comprehensive view of issues to be observed, action plans, and follow-up review statuses. Using DDworks21 Global, a user can not only create, manage, and track TMF in document life cycle, but can manage and track TMF status and keep TMF documents after documents enabling.


  • Database structure that provides complete visualization and tracking of monitoring, compliance, and issues
  • Relational database of monitoring, documents, issues, and action items
  • Company-wide system that ensures work performance is sustained at inspection-ready levels
  • Monitoring visit reports and contact reports (PI/Site, CRO and Vendor etc.) can be created, submitted, approved, and managed
  • Capability to freely define the report type, report checklist, and approval route
  • Elimination of time lags in issue detection
  • Capability to identify causes quickly and resolve problems completely
  • Facilitation of prompt and appropriate measures without omission
  • Built-in prevention measures for problems of identical or similar natures
  • Reduction of workload, elimination of unnecessary processes, and prevention of credibility loss
  • Simplification of management-targeted TMF documentation lists that can be easily distributed to essential personnel
  • Visualization of TMF document status from creation to storage
  • Immediate detection of missing TMF documents
  • Master data of TMF is based on the DIA TMF Reference Model version 2.0
  • Meets 21 CFR Part 11 Rule on electronic records and signature


  • Enhanced Reaction: DDworks21 Global allows organizations to make timely decisions, immediately detect problems, and maintain regulatory accountability.
  • Improved Information Access: With DDworks21 Global, study information can be obtained in a timely manner. Additionally, the solution offers multi-dimensional information analysis and eliminates reformatting workloads.
  • Mitigated Quality/Compliance Risk: DDworks21 Global offers access to best-in-class monitoring and TMF tools, and ensures a GCP compliance baseline through proactive GCP alerts.
  • Resource Savings: The solution reduces the workload and time duration of clinical trials while improving their quality.