A PHASE 1 ONCOLOGY STUDY IN ADULTS WITH METASTATIC BONE PAIN
Kayentis delivered the electronic solution for daily capture of:
- an NRS-based pain instrument supporting the primary efficacy endpoint
- and a daily pain medication eDiary supporting the secondary endpoint.
Study start-up completed in 5 weeks* thanks to:
- Powerful technology
- Reusable assets
- Strong partnership enabling early planning and efficient decision-making
*significantly faster than the commonly reported 10-14 week timeline from kick-off to go-live.
Early Vendor Engagement
The sponsor involved Kayentis before final protocol finalization, resulting in:
- Risks identified earlier
- Platform capabilities aligned upfront
- No late surprises
Licensing Completed Early
The sponsor and Kayentis mapped instrument licensing at initial protocol review, allowing for:
- all copyright approvals secured
- author requirements obtained
- any missing source translations identified and ongoing
…all before kick-off
A Highly-Prepared Kick-Off
The sponsor team arrived with:
- Visit schedules
- Endpoint strategy
- Device requirements
- Workflow requirements
eg., BYOD vs site-provisioned devices, questionnaire completion order, required reminders and alerts
leading to fewer discovery cycles and faster design approvals.
6 Best Practices for Accelerating eCOA Study Start-Up Timelines
Building on Kayentis' Experience
Leveraging Kayentis’ prior experience, expert teams, and validated assets helped deliver:
- Faster configuration
due to previously implemented questionnaires - Faster review cycles
due to previously author reviewed/approved content
Reduced risk
True Partnership
The sponsor and Kayentis worked as one team, with:
- sponsor-level governance structure
- quick decision-making through weekly and ad hoc meetings as needed
- transparent communication
resulting in issues being identified and resolved quickly.
