TransCelerate and Medidata Explore SDV Effectiveness in Upcoming Webinar
It’s no secret that clinical trial complexity and drug development costs are at an all-time high. With more than 30 percent of trial budgets allocated to site monitoring costs—and more than half of that being spent on source document verification (SDV) activities¹—the idea of implementing a risk-based monitoring (RBM) program to rid ourselves of the traditional 100-percent-SDV approach has the life sciences industry buzzing. As long-time proponents of RBM methodologies, we recently teamed up with TransCelerate BioPharma Inc. on a joint initiative to assess the relative effectiveness of SDV on overall clinical data quality, providing TransCelerate with robust data analytics to help determine:
a) How much eCRF data is actually changed due to SDV, and
b) How many subject events (AEs and SAEs) are initially “missed” by investigative sites and added to the eCRF at a later time
The recently-published results* not only support the hypothesis that SDV has a negligible impact on data quality, but also reinforce the value of RBM-focused activities. So now that we know how effective an RBM program can be, how do we establish a holistic strategy that not only results in a reduction in SDV, but also includes upfront risk assessment, centralized monitoring to proactively identify risks, and more? And how do we ensure data quality remains high?
• By doing less SDV and more SDR (source data review)?
• By relying more heavily on EDC auto-queries?
• By increasing centralized monitoring review of KRIs?
To explore these questions and more, Medidata and TransCelerate have come together to co-host an upcoming webinar in which they will take a deep dive into the results of their joint-SDV analysis, as well as share how to successfully apply them to any risk-based monitoring study.
TransCelerate and Medidata Discuss SDV Findings and Application to Risk-Based Monitoring
Monday, November 17, 2014 12:00-1:00 pm ET
We hope you can join us as we continue to explore the benefits—saving time, money and resources—of this growing industry trend.
¹ IOM (Institute of Medicine). 2010. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington, DC: The National Academies Press.
*Evaluating Source Data Verification as a Quality Control Measure in Clinical Trials, in Therapeutic Innovation & Regulatory Science (the official journal of the DIA).