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.
Moving boxes surrounded Kim Rejndrup in his new Florida home shortly after he joined OmniComm Systems, Inc. as senior vice president of Product Development. It was a 1,470-mile career move from Boston, where he had spent nearly 20 years at Oracle Corporation as vice president of Development for many of Oracle’s clinical research applications, including systems for electronic data capture (EDC), clinical trial management, data management, medical coding and data warehousing.
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.