Risk Reduction through Compliance Assurance
Disorganized paper regulatory and source exposes sites to compliance risk. Study binders can contain mis-tracked versions, particularly as documents are switched between paper and digital formats during sponsor communications. Moreover, paper management approaches allow missing and expired documents to go undetected until audit. Implementing an eBinder system reduces or eliminates those risks and drives the following compliance benefits: • Alerts provide compliance risk reduction between monitoring visits • Version control ensures the right version of documents are in the study team’s hands • Audit trails ensure the right processes were followed Programmable workflows deliver consistent process across teams and studies
$2,000 average per study
Net: A negative compliance finding puts future sponsor opportunities at risk. A research center managing 50 studies may find their next $100,000 study to be in jeopardy. Spread across other studies this equates to $2,000 per study.
The ROI of an eRegulatory Platform
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