On January 23, 2013, the Department of Health and Humans Services (HHS) published the Omnibus Final Rule (Final Rule) which modifies the "HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act and the Genetic Information Nondiscrimination Act of 2008."
Quintiles report of health care executives reveals how to improve success in a new competitive landscape
Clinical Research Advantage (CRA), a network of clinical trial sites, has further expanded its geographic and therapeutic reach by acquiring the late phase division of Comprehensive Clinical Development (CCD).
Data Sharing Commitments will Enhance Research and Scientific Knowledge, Advance Patient Care and Improve Public Health
In the febrile atmosphere of Europe's debates on transparency, could there have been a worse moment for the recent allegations in the UK daily newspaper, The Guardian, that the drug industry is secretly pressuring patient associations to advocate restrictions on the release of clinical trial data?
With all of the talk and emphasis on data and using technology and tools to determine better monitoring strategies, the other component becomes operational. What will companies do internally to manage a monitoring shift?
Courtney McBean, president and co-founder of Blueprint Clinical, explained in Part 1 about what made her decide to start up a technology company that specifically addresses risk-based monitoring (RBM).
In the past week, I?ve had two interviews and one webinar all related to some form of safety measuring and diagnosis definition primarily in the CNS area.
A consortium of leading biopharmaceutical companies is moving forward with several projects to make clinical trials more efficient and less costly.
VirtualScopics, Inc., a leading provider of quantitative imaging, today announced that they have completed analysis of a greater than 10,000 scan Phase III breast cancer study one week ahead of the six week contract period of the study utilizing a recently launched 3rd generation analysis platform.
A recent Op-Ed piece in the New York Times by Clifton Leaf asked the question "Do Clinical Trials Work?"
There are significant challenges facing the pharmaceutical and contract research organization (CRO) industries in relation to patient recruitment of clinical trials and the need to implement new strategies to finally overcome what has been called ‘the most difficult and challenging aspect of clinical trials.’
Pharmaceutical companies are paying more attention to value than ever before.
Clinical Trial Disclosure Solution Improves Compliance, Productivity, Cost Savings
As the attention on risk-based monitoring continues, more companies and sponsors are revealing their past and present strategies to address or improve this area of clinical trials.
The European Union's bid to update its clinical trials rules, "is particularly important for better competitiveness at global level, by encouraging research and innovation, maintaining a strong pharmaceutical industry and more clinical trials in Europe, and seeking better access to drugs for EU citizens."
You know those moments when you come across a really exciting idea, and you say to yourself, "why didn't I think of that?"
Source data verification (SDV) remains a concept that many sponsors, CROs and sites take to heart.
Clinlogix Selected as a Member of Ruta N Innovation Center
Recently, the National Health Service (NHS) in the UK announced that there was an increase of NHS patients participating in clinical research.
MannaResearch, a group of independent clinical research centers, announces the successful acquisition of Kells Medical Research Group, a Montreal-based clinical investigator site.
Theorem Clinical Research and Emergo Group have formed a strategic relationship to provide global regulatory consulting services, including reimbursement consultation and in-country regulatory representation services, to the medical device and in vitro diagnostics community.
Greenphire, the leading provider of payment technologies for the clinical trials industry, today announce the launch of a strategic partnership with Ernst & Young.
A recent paper published in PLOS ONE addresses research institutions? willingness ?or lack thereof?to defer to central institutional review boards for multicenter clinical trials.
ArisGlobal, a provider of solutions to the life sciences industry, announced the agCenter? 3.1, a clinical research investigator site portal that facilitates and streamlines the communication and collaboration between sponsors and their clinical study sites.
Deal Expands STG Presence in Healthcare Research and Services
This is certainly a question that stimulates a great deal of debate amongst industry professionals, even those working in Pharma companies that explicitly request all CRAs working on their projects have at least 2 years? prior experience
A report released today (27 June 2013) by the National Institute for Health Research Clinical Research Network (the clinical research delivery arm of the NHS) shows that more than 630,000 NHS patients in England took part in clinical research studies last year ? the highest level since the Network?s figures began.
The lack of accurate and extensive data about the safety and effectiveness of a wide range of drugs in pregnancy has restricted the treatment of pregnant women and contributed to an underlying health problem over the past 20 years, according to an editorial published in the June issue of Drug and Therapeutics Bulletin (DTB).