ICON’s rescue trial solution offers the smooth take over and seamless delivery of image analysis results according to your clinical trial schedule.
- Ease with charter development
- Rapid start up
- Expedited read completion and delivery
Benefits of ICON's rescue study solutions:
We will take over and seamlessly deliver image analysis results according to your trial schedule delivering:
Ease with charter development: If you already have an established charter, ICON will perform a gap analysis to ensure that our high standards are incorporated into this charter content while still maintaining already agreed criteria specific to the trial / protocol.
Rapid start up: From award to independent read EDC system release, ICON Medical has expedited turnaround time to support rapid system release and central review start for studies in rescue. For some clients we have delivered a timeline of 12 weeks from Charter development to EDC release date (includes charter development, technical specification writing and EDC programming, full validation, and release to production.)
Site Image Manual (SIM) development: We will manage image quality control to ensure that the data received is complete (no missing series) but will avoid query issue and pass the data for independent review. When ICON involvement begins in the middle of an ongoing trial, imaging parameters are aligned with site standard of care to avoid unnecessary query issues, but still maintaining a high level of quality and consistency.
Expedited read completion and delivery: In past rescue successes, we have accurately forecasted a large pool of independent readers to support a sizeable bolus of image data in a short period of time. ICON has previously supported reading over 600 imaging timepoints from EDC release to live data transfer in 18 weeks. This timeframe includes reader training on the system and criteria, the read assessment, approval of test data transfer, and full data review and edit check process performed prior to the live production data transfer.