Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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Reimagine clinical development by intelligently connecting data, technology, and analytics to optimize your trials. The result? Faster decision making and reduced risk so you can deliver life-changing therapies faster.
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Building on a rich history of developing AI for healthcare, IQVIA AI connects the right data, technology, and expertise to address the unique needs of healthcare. It's what we call Healthcare-grade AI.
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The IQVIA Human Data Science Cloud is our unique capability designed to enable healthcare-grade analytics, tools, and data management solutions to deliver fit-for-purpose global data at scale.
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SEARCH JOBSEffective risk-based monitoring (RBM) can make an entire trial run more smoothly. If the monitoring team is proactive about identifying risks and responding to queries it can streamline the research process.
But when they aren’t, it can create unnecessary delays.
Clinical monitoring can account for up to 50% of study costs, in part due to chronic inefficiencies. One study found that one-in-three case record from (CRF) pages result in some form of data query. Request for confirmation made up half of these requests, while the others included request for clarifications (28%) and missing data (22%).
Many of these monitoring queries could be avoided through more efficient communication between monitors and sites. However, when all of RBM tasks fall to individual contract research associates (CRA), time constraints can make that efficient communication impossible.
CRAs often have heavy workloads that require frequent travel, juggling multiple sites and studies, with hours of data collection and review. This means they aren’t always available to respond to questions. Even when they are on site, they may be so focused on collecting and monitoring data that they have little time to engage with site staff, or to proactively problem-solve future monitoring issues.
This challenge is aggravated by the high rate of turnover among CRAs, which can cause delays as new team members ramp up.
Rather than continuing to put all the burden on CRAs, IQVIA has developed a more collaborative and evolutionary approach to monitoring, which leverages central monitors (CMs) to deliver a more streamlined process.
Using this model, CRAs partner with a CM located in a local time zone. The CM connects with every site bi-weekly or monthly (depending on a preferred cadence) to have focused discussions with the site team about risks and compliance concerns.
They also function as a daily point of contact whenever a need arises. Sites can reach out to the CM by phone or e-mail to quickly address queries, or ask questions about protocols, supplies, vendor management, etc. Because CMs work from an office, they are available during standard working hours and speak the local language. This ensures sites get prompt attention as issues or question arise. The CM also conduct a remote review of data to identify emerging risks or to address site performance and metrics.
While the CM manages these day-to-day queries, CRAs continue to be accountable for site performance and quality. They conduct on-site visits and perform all activities that require site presence, including Source Data Verification SDV and necessary site training.
This combination of CM and CRA leads to a timelier monitoring environment, which can improve compliance, increase site support, and lead to a better work/life balance for busy CRAs.
The impact of this new approach to monitoring can be seen almost immediately. IQVIA has worked on several studies that experience remarkable improvements when they implement this evolved RBM model. These include a sponsor in India who ran a standard RBM model for more than a year, then switched to central monitor approach in late 2021.
We are seeing similar improvements across studies adopting this model. One comparison of 4 IQVIA studies using RBM vs this evolved RBM in Q4/21 shows:
These metrics prove that adding a CM to the monitoring team works. And in an era where research delays can cost sponsors millions of dollars in lost revenues, and drive frustration and turnover among key staff, implementing a model that streamlines the research experience can reduce costs while helping to maintain continuity across the trial team.
Explore our end-to-end, full service clinical development capabilities including Therapeutics expertise, Development Planning, Phase I early clinical development, Phase IIb/III and Phase IV Trials, Regulatory Submission and Post-Launch Studies.
Change the model of clinical research by integrating data, expertise, analytics and technology from study design through execution to power better decisions.
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Enhance patient safety and study quality by using data, analytics, and technology to monitor patient, site, and study performance with risk-based and centralized monitoring.
