Activate clinical sites faster with smarter Study Start-Up.

Study Start-Up is the phase in which clinical trials are set up for execution, covering site selection, regulatory approvals, document preparation, and site readiness activities.

Traditionally, Study Start-Up is highly manual and fragmented. As studies expand across regions and teams, it quickly becomes difficult to manage speed, accuracy, and compliance at scale.

• Manual, time-intensive documentation: Creating and managing critical documents such as Informed Consent Form, FDA Form 1572, Confidentiality Disclosure, and other site-specific regulatory documents often requires significant manual effort, slowing progress and increasing the risk of inconsistencies.
• Global complexity without standardization: Country-specific regulations, formats, and approval processes make it difficult to maintain consistency and scale across regions. Documents need to be translated into the site’s native languages for clarity in communication and regulatory needs.
• Limited visibility: Progress across teams and dependencies is difficult to track, making it harder to identify risks early, before trial timelines are impacted.
• Fragmented data across systems: Activities like site visit planning and tracking IMP green-light milestones are spread across emails, spreadsheets, and disconnected tools, making processes highly person-dependent and reliant on tribal knowledge.