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Steve Young

Recent Posts

Risk-Based Monitoring Insights from the Industry

Steve Young: Jun 16, 2016 3:39:54 PM

Steve Young, Senior Director of Transformation Services at OmniComm Systems provides some great insight on Risk-Based Monitoring (RBM).

When it comes to the practical implementation of Risk-Based Monitoring, where do you observe differences in current best Risk-Based Monitoring practices between companies and CROs of different size?

I strongly believe that simplicity is key to successful implementation of Risk-Based Monitoring for any organization. I have unfortunately seen too many organizations unintentionally over-engineer processes at their first attempts, particularly in areas such as the pre-study risk assessment and risk identification. The start-up period of a study is a very busy time for cross-functional study teams, so organizations implementing Risk-Based Monitoring need to make sure they don’t create a resource- and time-heavy process which will increase burden and may actually contribute to increased risk.

RBM Implementation - Top 3 Areas to Simplify

Steve Young: Sep 14, 2015 1:53:00 PM

Risk-based monitoring (RBM) presents a tremendous opportunity for the life sciences industry. The FDA and the EMA have both issued very strong endorsements for RBM through their guidance documents issued over the past couple of years, clearly signaling to the industry that this paradigm represents a superior approach to achieving quality in the conduct of clinical research. And RBM also presents a tremendous opportunity in terms of resource efficiencies, particularly in the area of site monitoring. The following graph comes from an RBM value calculator developed at OmniComm, and illustrates the significant value that can be realized for a typical phase 3 study – value derived not just from resource efficiency gains but from improved quality as well.

RBM Adoption – Taking the Industry Pulse

Steve Young: Jun 11, 2015 5:15:00 PM

OmniComm recently conducted a well-attended RBM webinar during which we polled the audience regarding their organizations’ progress with RBM adoption. The following two questions were asked in particular:

Clinical Operations Quality – What Is It and How Is It Ensured?

Steve Young: May 16, 2015 1:12:00 PM

What do we mean when we talk about “quality” in the context of conducting clinical research?  Quality can be a very elusive concept.  Fortunately we have a documented set of rules and guidelines – under the umbrella of Good Clinical Practice (GCP) – that establish objective standards by which quality in clinical research is judged.  The volume of GCP regulations and related guidance is extensive, but virtually all of it is directed at the following two imperatives: