In case you’re not familiar with PhUSE, it’s an independent organization that serves as a global platform to discuss topics surrounding programming in the regulated environments of the pharmaceutical and biotechnology industries. And on July 21st, 2016, PhUSE is hosting a single day event entitled, “Utilizing Risk-Based Monitoring to More Effectively Identify and Mitigate Risk While Ensuring Patient Safety, Data Quality and Integrity” in Deerfield, IL.
As a member of the PhUSE community, Eliassen Group’s Biometrics and Data Solutions’ Director, Parag Shiralkar, will present his perspective on the following topic:
How can I contribute to Risk Based Monitoring? A Statistical Programmer’s Perspective
Abstract: Detection and addressing the data quality issues during trial progression is a key responsibility of data management. While EDC and data management functions do their best to ensure highest data quality by adhering to their standard operating procedures, certain data issues originated at clinical sites slip through these operations.
Most of the current set of EDC tools are deployed at sponsor side rather than at clinical sites. In these circumstances, when statistical programmers are tasked to analyze, tabulate and report the clinical data, many times the analyses reveal significant issues with data that trace their roots with how the data is entered at sites.
There have been significant efforts taken by Transcelerate Pharma to implement statistical methods for risk based monitoring to ensure integrity of trial data. This presentation provides some illustrative examples where statistical programmers involved in downstream data operations can actually identify major issues pertaining to the data entered at sites and improve trial integrity.
Are you planning to attend PhUSE? If so, drop us a line so that we can connect with you at the event: firstname.lastname@example.org.