Please fill in the form on the right to view the recording. Following the live discussion, we compiled a Q&A document answering questions that were posed from our audience, which can be found here.
Summary:
A growing number of our Sponsor clients monitor or plan to monitor certain ongoing studies using interim data loads as and when they become available from CROs and specialty labs.
During this discussion, you will hear directly from senior industry partners on how analysis-ready data, in short, leads to submission-ready data.
Timestamp of the recording:
| 6:30 | Creating electronic data environments for preclinical studies to monitor interim data from ongoing studies: a discussion of parameters and study types |
| 10:55 | How Sponsors integrate with their CROs for interim data load; How often data is loaded |
| 13:20 | Establishing a Virtual Data Room for secured data upload on a per-study basis |
| 16:15 | What do Sponsors do when they observe AEs during a trial? How do Sponsors group cohorts and define study parameters to observe responses? How does this change Sponsors’ workflow? |
| 20:39 | Cross-study analysis of completed studies against ongoing (interim) study data: possible? |
| 24:20 | How does interim study monitoring support collaboration internal to the Sponsor? What about with team members that are not as familiar with SEND? |
| 30:30 | Can you use your data for analysis before it is in SEND? |
| 37:25 | Making data driven decisions (change in dosing, dosing holiday, etc.) |
| 40:10 | Does the CRO have to load the data in a file-neutral format? Is there an extra charge associated with higher frequency uploads? |
| 50:56 | A brief demonstration of the Xbiom™ platform used for interim study monitoring, SEND dataset visualization, and cross-study analysis of completed studies |
The Q&A document that was compiled from this live discussion can be found by clicking on this link.
If you have any additional questions or would like to request a demo, please reach out to ask@pointcross.com.