Study Start-Up
Where a successful trial launch begins its ascent
To optimize the study start-up process, automate it. Removing manual tracking streamlines the processes to eliminate aggravating bottlenecks and ensure quality from the start.
Benefits
- Fully configurable to optimize processes
- Automates the study startup process
- Templates provide critical regulatory knowledge
- Enables the team to meet timelines by focusing on critical path items
- Increases end-to-end visibility of study lifecycle
- Enhances communication between teams (e.g., start-up, regulatory, and clinical)
Features
- Investigator database with site creation and contact management
- Activity and document tracking in a managed, validated system including IP tracking
- Pre-defined country submission documents and expected approval timelines
- Built-in project management critical path with associated timelines
- Status sharing internally and to customers via direct access and/or APIs to local systems
- Manage Investigator DB at the institutional level– BENEFIT of this Ensures data quality and eliminates duplicate entries
Configurable Applications
Study Start-Up + CTMS
Eliminate communication gaps and missed triggers between startup and clinical groups. No more relying on email and spreadsheets for crucial site qualification visits and site initiation visits.
Study Start-Up + RBQM
Launch your study with data quality and risk mitigation in mind. Quickly collaborate with your team and gain the visibility you need for effective startup and quality control.
Study Start-Up + RBQM + CTMS
Take your clinical trial to the next level by adding RBQM. Now you can effectively manage your study data from the first site identification to the last patient visit.