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PharmaVigilant introduces I-Monitor

PBR Staff Writer Published 30 August 2011

PharmaVigilant has rolled out I-Monitor to improve speed, accuracy and regulatory compliance, while still reducing sponsor costs.

With the help of I-Monitor solution, the sites will fill out the source worksheets and transmit them to PharmaVigilant.

This could be accomplished via a scan, or can be sent to PharmaVigilant who will scan the certified source documents into I-Vault.

Following that, a PharmaVigilant data specialist will enter the data from the source worksheets into the EDC system, eliminating data entry at the site.

System edit checks representing approximately 70% of queries will be addressed by the data specialist and escalated to the site if necessary.

PharmaVigilant rSDV specialists will then remotely monitor the data in <5 business days from the point of data transference from the site.

The solution also enables on-site monitors to reduce the number of site visits, ensuring a cost effective and less disruptive site approach to verifying data.

PharmaVigilant founder and CEO James DeSanti said with I-Monitor, site involvement in the data entry and query resolution process is now significantly reduced, allowing study coordinators more time to address enrollment and patient related activities.

"The significant advantage is that it streamlines timelines by taking less than five days to enter, review, and address any data entry issues, which is unparalleled in the industry," DeSanti said.