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OmniComm and eClinical Forum Release Survey Results on ICH-E6(R2) and RBM implementation

Abby Abraham: May 23, 2019 12:15:00 PM

Changes to ICH-GCP requirements— in the form of ICH-E6(R2) — and adoption by regulatory agencies are expected to impact processes and operations in the clinical research industry. A new survey from eClinical Forum, in partnership with OmniComm Systems Inc., highlights the current state of implementation of ICH-E6(R2) and RBM in various segments of the clinical research industry.  The survey results pointed to a sharp divergence in implementing ICH-E6(R2) and adopting risk-based approaches to monitoring between large sized and non-large organizations.

Testing the RBM Waters — A Global Midsize Sponsor Weighs the Benefits of RBM Implementation

Sharon Rosenberg: Jan 9, 2019 12:28:26 PM

Risk-based approaches to monitoring (RBM) have become widely accepted in the clinical trials industry. Due to limited financial and operational resources, smaller organizations face multiple challenges when adapting to rapid industry changes. A variety of factors contribute to the slower adoption of RBM in smaller organizations.

Is Site Productivity Worth Worrying About?

Keith Howells: Sep 25, 2017 12:43:30 PM

Once a site has collected the data for a patient visit, the coordinator has the tiresome task of entering that data into the clinical trials system. One day the data will just flow in from the EHR system – more about that in a future blog – but today the vast majority of clinical data is re-typed into an EDC system.

Experts to Gather for Risk-Based Monitoring Symposium in North Carolina

Stephen Caravaglio: Aug 16, 2017 12:17:50 PM

How does the latest revision to The International Council for Harmonization (ICH) Good Clinical Practice (GCP) E6 guideline affect risk-based monitoring (RBM) strategies, and what role does ICH GCP E6 (R2) play in sponsors’ expectations of contract research organizations (CROs)?

Risk-Based Monitoring EDC System Enablement

Dennis Constantinou: Nov 13, 2016 9:37:52 PM

Clinical trials are not nice neat compartmentalized studies that occur in one lab. They tend to be massive projects that cover as many as 500 different sites – that means 500 locations producing data for collation and analysis. Instead of looking for a needle in a haystack, monitors have to tear apart 500 different haystacks looking for the one errant needle.

Historically, monitors went from site to site to investigate potential problems and make sure everything was running as planned. Electronic data capture and risk-based monitoring have changed the way monitors function to improve processing, reduce backlogs and enhance clinical studies.

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:


Roberta Alexander, Ph.D.: May 28, 2015 5:22:00 PM

San Diego Clinical Research Network (SDCRN) organized another great event on May 21, 2015 to address Risk Based Monitoring (RBM) in clinical trials. This event was co-organized with OmniComm, an Electronic Data Capture and eClinical Solutions company, and ResearchPoint Global, a full-service CRO with 22 global offices and clinical coverage in more than 60 countries.

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: