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Trial Interactive

Study Start-Up

Automate manual processes, mitigate obstacles, predict timelines, and simplify EC/CA/IRB submissions and approval.

Trial Interactive’s configurable Study Start-Up solution accelerates site activation with process automation, obstacle mitigation, timeline projection, and simplified regulatory submission. Trial Interactive has increasingly been implemented by study teams seeking to activate sites faster and ensure the path to starting the study itself is continuous and simple through seamless eTMF integration.

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Study Start-Up Highlights

  • Create Essential Documents and Submission Packages
  • Estimate/Track Deadlines, Predict Activation Timelines
  • ID Missing Documents and Statuses
  • Protocol Amendment
  • Forecasting and Oversight Dashboards and Reporting
  • Identify Mitigating Factors Delaying Site Approvals
  • Get Alerted to Top Sites Ready for Activation
  • Distribute and Submit Regulatory Packages
  • Central IRB Integration for Easy Submission
  • Regulatory Review Workflows
  • Track Submission/Approval Statuses
  • Milestone and Task Management
  • Fully Configurable QC, Final Packet Configuration
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Expedite Site Selection by 35%

  • Simplify Process to Site Activation

  • Streamline Regulatory Package Submission

  • Accurately Forecast Start-Up Milestones

  • Predict Approvals and Expedite Activation

  • Eliminate Paper Processes

  • Automate Document Management and Control

  • Real-Time Reporting and Oversight

  • Improve Stakeholder Collaboration

  • Get Realistic Timeline Predictions

  • Reveal Bottlenecks Throughout the Site Activation Process

  • Reduce Compliance Risks

  • Seamlessly Transition from SSU to eTMF

  • Reduce Cycle Times and Ultimately Start Recruiting Patients Faster

  • Get Insights and Alerts on Documents/Submission Progress

"We were looking for a way to conduct our 500-site global trial more efficiently. Trial Interactive's Study Start-Up and eTMF solution enhances transparency for both Regado and its partners, and allows us to run the study with as little paper as possible."

Raul P. Lima, Executive Director of Clinical Operations, Regado Biosciences

“At CTI approximately 80% of our studies meet or exceed enrollment expectations, despite the challenging patient populations we work in, which is due in part to our excellent pre-trial and start-up processes. With its automation and global document management capabilities, Trial Interactive helps us streamline our study management process while meeting regulatory requirements, allowing for remote inspections and even faster start-up timelines.”

Kevin Schwarz, COO, CTI

eTMF and TMF Services

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