Biomedical Systems Announces Affiliation With the ePRO Consortium
March 24th 2015Biomedical Systems, a premier global provider of centralized diagnostic services, announced its affiliation with the Electronic Patient-Reported Outcome (ePRO) Consortium, a program run by the Critical Path Institute (C-Path).
De-identifying Clinical Trials Data
March 20th 2015Whether we are referring to CSRs or to IPD, the personal information of trial participants needs to be de-identified prior to release. This article will describe the available methods for de-identifying clinical trial data, and the relative strengths and weaknesses of each.
EMA Marks 20th Anniversary with Congress & Book
March 19th 2015To celebrate 20 years since its opening, the European Medicines Agency (EMA) organized a one-day meeting this week. Called “Science, Medicines, Health: Patients at the heart of future innovation”, the invitation-only event in London focused on the EMA’s future role
Sentiment Analysis: Understand Your Healthcare Customers
March 17th 2015Sentiment analysis can give health care organizations a competitive edge in understanding what customers think about their healthcare experience, to help reduce costs and improve care service and to lead to new clinical research and treatments. In addition, it taps into a new channel of pharmacovigilance input information that can enable Marketing Authorization Holders to keep abreast of opinions on the safety of their products in real time.
Western Institutional Review Board Receives ISO Certification
March 16th 2015WIRB-Copernicus Group (WCG), the world’s largest provider of regulatory and ethical review services and software to support clinical research, announced today that its Western Institutional Review Board® company has been certified to ISO 9001:2008 by BSI.
Where is the “Quality” in GCP?
March 16th 2015Over the years, clinical study management has become more fragmented. There are more organizations participating in a study, each bringing their own experiences, interpretations of requirements including how quality is defined. How is it possible that requirements and quality be interpreted so differently?
Medical Device Sponsor Receives FDA Approval Using Target Health's Services
March 12th 2015?Lund, Sweden-based Dignitana, a manufacturer of medical cooling devices, engaged CRO Target Health in 2011 toward its approval of DigniCap® System, its product to protect cells and hair for patients in chemotherapy treatment.