PharmaVigilant Releases New Solution, I-Monitor: The Future is Now.
WESTBOROUGH, Mass. -- PharmaVigilant, an e-clinical provider, launched a new solution, I-Monitor. The solution enhances the sponsor footprint at the site, significantly improving speed, accuracy and regulatory compliance, while still reducing sponsor costs. Sites fill out source worksheets and then I-Monitor takes control - for the sponsor. Sites transfer their data entry tasks to PharmaVigilant's experienced data specialists to ensure highly accurate entries in a minimum turnaround time.
With services offered by I-Monitor, the sites will simply 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. A PharmaVigilant data specialist will then 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. This function eliminates the need for double data entry, saving time and money while ensuring clean data. This 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 will close the loop, providing on-site monitors to address any specific forms and/or issues. I-Monitor is an end-to-end proven solution that has documented significant savings to the Sponsor in both time and money.
"With I-Monitor, PharmaVigilant is significantly reducing site effort (the sponsor's customers), while increasing site satisfaction. 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. This leaves the time consuming data entry/monitoring processes to remote specialists and a reduced number of onsite monitors," said James DeSanti, Founder and Chief Executive Officer, PharmaVigilant. "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."
Based in Westborough, Mass., PharmaVigilant is a SaaS company founded to provide broader solutions to streamline the clinical trial process for biopharmaceutical companies. Its full suite of SasS solutions automate the collection, management and analysis of clinical trial data. For more information, visit www.pharmavigilant.com.
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|Date:||Aug 30, 2011|
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