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.
- 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 and
Get insights and alerts on document/submission progress
Get realistic timeline predictions
Reveal bottlenecks throughout the site activation process
Reduce compliance risks
Seamlessly transition from study start-up to eTMF
Reduce cycle times and ultimately start recruiting patients faster
- Simplify Process to Site Activation
- Streamline Regulatory Package Submission
- Accurately Forecast Start-Up Milestones
- Predict Approvals & Expedite Activation
- Eliminate Paper Processes
- Automate Document Management & Control
- Real-Time Reporting & Oversight
- Improve Stakeholder Collaboration
"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“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.”
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