Snapshot Shows Targeted Site Monitoring Trend
Clinical R&D organizations across the industry have been steadily moving away from the traditional approach to site monitoring using 100% source document verification (SDV) of subject eCRFs, and into a new paradigm where a targeted sampling of the subject eCRF data is verified against source charts.
SPOTLIGHT EVENTRisk-Based Monitoring – Part Two In Depth ReviewMarch 13, 2014
Cambridge, MassachusettsDownload BrochureRegister
RELATED
- Increasing Intensity of On-Site Monitoring a Troubling Trend
- Industry Metric Indicates Low ROI with Full Source Document Verification
- Has FDA Guidance on Risk-based Monitoring Impacted SDV Coverage Yet?More in Risk-Based Monitoring
Clinical R&D organizations across the industry have been steadily moving away from the traditional approach to site monitoring using 100% source document verification (SDV) of subject eCRFs, and into a new paradigm where a targeted sampling of the subject eCRF data is verified against source charts.
The graphic demonstrates the trend via the average percent of eCRF data marked for SDV from 2007 through 2010. The information is based on data from over 1,500 studies conducted by 50 R&D organizations, compiled by the Medidata Insights metrics warehouse.
The data reveals a steady, significant downward trend over the four year period, from a high of 85% in early 2007 to a low of 67% in late 2010. This trend is expected to continue over the coming year and beyond, particularly with the support of the recent guidance provided by FDA in support of risk-based site monitoring practices.
Each month, an Insights benchmark to highlight emerging trends in clinical development will be featured. For more on the industry benchmarks included with Medidata Insights, please visit mdsol.com/insights.
—Medidata Solutions, http://www.mdsol.com
FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
April 30th 2025Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
