Let PharmaVigilant Do the Work For You
Sites have told sponsors for decades that they want to focus on the patients/subjects, and not paperwork. However, it is the paperwork that defines the data, and the quality of the regulatory submission.
I-Monitor is the first total solution that leverages the latest technology in providing a solution. The sites just have to 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. 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 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 will also eliminate the need for double data entry, saving time and money. The site will have clean data, electronically available to them in <5 business days. This enables on site monitors to reduce the number of site visits (when applicable), reducing pressure on both the sites, and costs. Why is this different - the technology and how it is implemented.
Reduce Site Effort, Increase Site Satisfaction
The chart below clearly outlines the reduced effort by the sites in initial data entry and review, while ensuring accuracy and improved response times. Site involvement is outlined in yellow, as PharmaVigilant (PV) can handle all the segments in blue. The key is the time it takes to deliver the solution: <5 days.