Post-approval adverse event reporting for clinical trials

Technology Services

For more information on PPD's post-approval technology services, please choose an option from the drop-down box below.



Adverse Event Adjudication

PPD GlobalView EventNet™ is an Internet, network-based event management and adjudication solution that expedites the review of safety and endpoint-driven data for large-scale clinical trials or registries. This secure technology delivers clinical event information online and facilitates a global remote review process.

Faster, Cost-Effective Study Results

While traditional event review often involves a lengthy and time-consuming process, PPD GlobalView EventNet accelerates review and tracking of data by:

  • Managing the review and tracking process of events and source documents online, delivering real-time information to clients
  • Eliminating the need for face-to-face meetings for adjudication board members, saving travel and logistical expenses
  • Decreasing the amount of time required for review, providing faster study results

Online Data Repository and Report Management

PPD GlobalView EventNet provides a single online repository of site-level source documents, including lab data and images. The system schedules workflow and priorities for adjudicators, and provides online reports and posting of adjudication events to Web portals.

Online Event Review Process

  • Provides real-time access to a secure online data repository of events or endpoints and site-level documents
  • Accelerates the adjudication process by enabling board members to review the information at their own convenience in any location globally
  • Compares and stores board member decisions electronically, and flags any unresolved issues needing a full committee review
  • Accommodates customization needs, including multiple event adjudication boards within the same study

Built on Proven Technology

PPD GlobalView EventNet is built upon PPD's proprietary electronic data capture (EDC) solution, PPD GlobalView, a versatile Web-based data collection technology that utilizes the powerful data management capabilities of Oracle® on the back-end. Each deployment of PPD GlobalView follows established software development life cycle (SDLC) standards, and all PPD GlobalView databases are 21CFR Part 11 compliant.

 

Electronic Data Capture (EDC) | Adverse Event Adjudication

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