OmniBlog

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.

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).

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.

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.

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.

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.

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.  

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)?

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 20^th anniversary: