Can Monitoring Costs in Clinical Trials Be Reduced?

Kim Rejndrup on Feb 9, 2018 11:00:00 AM

Not long ago, clinical trials involved 100% onsite monitoring in an effort to ensure high data quality. But how effective and efficient was that process? Several analyses have shown that only 1-2% of data is corrected as a result of source data verification (SDV). Therefore, the concept of risk-based monitoring (RBM) was born. The goal was to complete a more targeted monitoring (<100% SDV) without compromising patient safety or data quality.

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Topics: EDC software, investigator sites

EDC CARE™: Maximizing the Value of Your EDC Investment

Meredith Bell on Dec 13, 2017 11:50:31 AM

It’s not inexpensive to develop a new drug or medical device. In 2016, bio/pharma companies spent approximately $127 billion on research and development. By 2020, R&D expenditures are estimated at $148 billion globally, according to PharmSource Information Services, a leading research and news outlet.

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Is Site Productivity Worth Worrying About?

Keith Howells on 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.

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Topics: Risk-Based Monitoring

Diligence and Dedication During Hurricane Irma

Sharon Rosenberg on Sep 18, 2017 6:19:15 PM

Hurricane Irma struck last weekend and left a long trail of damage and destruction. The catastrophic storm caused at least 32 fatalities and property damages of $20 billion to $40 billion in the U.S., according to the Associated Press.  

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Topics: Corporate News

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

Stephen Caravaglio on 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)?

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Topics: Risk-Based Monitoring

OmniComm Systems Celebrates 20 Years of Growth and Innovation

Sharon Rosenberg on Aug 8, 2017 3:17:40 PM

In technology, time travels at warp speed. Consider the evidence presented by Randy Smith, founder of OmniComm Systems Inc., in a letter written in honor of OmniComm’s 20th anniversary:

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Topics: Electronic Data Capture

10 Reasons Why We Must Integrate EMR and EDC

Ken Light on Aug 1, 2017 3:30:03 PM

My objective was to play counterpoint to the recent LinkedIn blog by Michael Crayne, titled: Why we can't integrate EMR and EDC and to provoke additional dialogue around this vital topic. However, I just learned the heartbreaking news that Michael passed away last week. So, I hereby dedicate this blog to his wisdom and service to our industry – with appreciation to Michael Crayne for provoking thoughtful debate and dialog, while expanding our collective wisdom. 

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Topics: EMR, clinical trials, Electronic Data Capture

OmniComm Announces 7th Annual Innovation Forum

Sharon Rosenberg on Jul 18, 2017 4:13:08 PM

OmniComm Systems announces the 7th Annual Innovation Forum. The annual gathering is scheduled for October 19-20 in Fort Lauderdale. Complimentary product training workshops will be held October 18. (Details below.)

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Booth #1112 at DIA 2017: Informal Presentations From Thought Leaders

Sharon Rosenberg on Jun 19, 2017 12:11:07 PM

Join us at Booth #1112 for a full menu of activities and presentations with OmniComm thought leaders at our DIA 2017 booth. Here's a short rundown:

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Topics: DIA 2017

DIA Countdown & Special Presentations at Booth #1112

Sharon Rosenberg on Jun 18, 2017 12:00:00 AM

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Topics: DIA 2017