General Data Protection Regulation: Updates & Discussion From OmniComm Systems

Sharon Rosenberg on Jun 1, 2018 12:07:46 PM

On the last Friday of May 2018, the General Data Protection Regulation (GDPR) took effect in Europe and generated headlines around the globe. GDPR was enacted to unify and fortify the protection of personal data for all EU residents. The regulation applies to all companies that conduct business within the EU and includes the export of personal data beyond EU borders.

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Topics: Corporate News

Trial Building Misconceptions: Are They Affecting Your Clinical Trials?

John Fontenault on May 16, 2018 4:46:00 PM

There are more than 270,000 clinical studies underway in all 50 states of the U.S. and in 203 countries, according to the U.S. National Library of Medicine (ClinicalTrials.gov).

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Early-Phase Research Hospitals and CROs Sign New TrialOne® Contracts in China

Sharon Rosenberg on Feb 28, 2018 12:44:00 PM

 

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Topics: Corporate News

Profile: Yvonne Rollinger, Managing Director of OmniComm, Named to Executive Board of BVMA

Sharon Rosenberg on Feb 22, 2018 11:35:12 AM

Did you know? About 4,000 clinical research employees in Germany have a valuable voice in the life sciences industry thanks to The Federal Association of Contract Research Organisations, (Bundesverband Medizinischer Auftragsinstitute, BVMA e.V.). Founded in July 1991, BVMA represents contract research organizations (CROs) based in German-speaking countries.

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SMART on FHIR and EHR-to-EDC Integration

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