The HIPAA/HITECH Omnibus Final Rule: Implications for Clinical Research
July 26th 2013On January 23, 2013, the Department of Health and Humans Services (HHS) published the Omnibus Final Rule (Final Rule) as a modification to the "HIPAA Privacy, Security, Enforcement, and Breach Notification Rules under the HITECH Act and the Genetic Information Nondiscrimination Act of 2008."
The HIPAA/HITECH Omnibus Final Rule: Implications for Clinical Research Blog
July 26th 2013On 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."
Clinical Research Advantage Acquires Late Phase Division of Comprehensive Clinical Development
July 24th 2013Clinical 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).
VirtualScopics Completes 6 week Analysis of Phase III Breast Cancer Study
July 22nd 2013VirtualScopics, 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.
Clinical Trials and Social Networking
July 18th 2013There 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.’
Edging European Legislation Uphill From Vilnius
July 11th 2013The 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."
Theorem Clinical Research, Emergo Group Form Strategic Relationship
July 9th 2013Theorem 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.
ArisGlobal Improves Sponsor-To-Site Management With Clinical Investigator Portal
July 9th 2013ArisGlobal, 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.
What Will it Take for the Industry to Accept Proof of Competence Over Experience?
July 8th 2013This 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
Figures Show "New High" in NHS Patients Participating in Clinical Research
July 8th 2013A 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.