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.
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.
