Study Start-Up

Study Start-Up

One of the many challenges in conducting clinical trials is the speed to completion and finalization of essential and regulatory documents by the investigative site personnel. Trial Interactive makes the process more efficient by integrating our Study Start-Up module with our eTMF.

Trial Interactive's Study Start-Up module offers real-time distribution of Essential Document packages, tracking of completion progress, IRB/EC submission and meeting dates to provide projections of ethics approvals. This yields a faster and more realistic timeline for site activation visible to study teams. Trial Interactive enables you to complete, submit, and securely host clinical trial-related regulatory documents online, significantly speeding up trial processes. The system creates efficiencies through streamlined communication between sponsors, sites, and CROs, driving time and cost efficiencies. Cycle time metrics can be viewed to allow study teams to become more efficient in all future studies.

Improved Collaboration with Insights
into All Study Activities

Trial Interactive's Study Start-Up module offers real-time distribution of Essential Document packages, tracking of completion progress, IRB/EC submission and meeting dates to provide projections of ethics approvals. This yields a faster and more realistic timeline for site activation visible to study teams.

Real time access to study information and documents across all trial stakeholders

Integration with Investigator database for site intelligence

Track study milestones

Single Study submission packages

Assign tasks and monitor activities across teams

Automate Document Management & Control

  • Agency submission package management
  • Drilldown dashboards for missing documents
  • View timeline projections
  • Notifications for document uploads and QC

Improved Compliance

Audit Trail Functionality
21 CFR Part 11
Support Country & Local Regulations

 

To find out more about how Trial Interactive can streamline your global Study Start-Up, contact us.

The Trial Interactive platform complies with all current and emerging regulations
including 21 CFR Part 11, ERES, ANNEX 11, GxP, and GDPR.

24/7
Access to site profile & Status

45%
Quicker Site Activation Times

90%
Reduction in Shipping Costs

Contact us to learn more about our Study Start-Up solutions

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