Has your company received an FDA warning letter? A proper response is critical and may mean the difference between whether the FDA accepts your response or determines that additional action is required. When crafting your response, make sure you do not make a bad situation worse by engaging in any of these mistakes.
Electronic Data Capture (EDC) systems have swept the Clinical Trials industry in recent years, promising to transform the drug development process.
Infectious Disease Clinical Research Program (IDCRP) is a worldwide network of Department of Defense (DoD) clinical and research centers that have collaborated to investigate infectious disease challenges facing the military.
The decision to switch an EDC platform for in-flight trials is not easy and is fraught with risks. A majority of companies continue to plough forward with higher costs and operational pains due to a failing EDC platform. Read this white paper and learn how Acceliant's low-risk EDC migration can deliver legacy EDC retirement, lower operating costs, and peace of mind for all teams working towards the success of a clinical trial. By Ven Thangaraj, CTO, Acceliant
On a global scale, the number of new molecular entities (NMEs) in development—and, more importantly, the number being approved by regulatory authorities— has dropped significantly in recent years.
With each passing year, clinical trials are becoming increasingly global. The business of product development is moving away from the traditional model in which studies are conducted primarily in the US – in fact, recent estimates indicate that within the next three years, up to 65 per cent of studies under FDA regulation will be conducted outside the US. A review of a US government clinical trials registry and of 300 published reports in major medical journals revealed that one third (157 of 509) of Phase III trials were being conducted entirely outside the US, with over half the study sites (13,521 of 24,206) used in these trials located overseas, many in eastern Europe and Asia.
While choosing the wrong product is never a good idea, when it comes to clinical trials software, the wrong product could be disastrous for your company.
If you’re like me and most people I’ve talked to, interviewing on either side of the table can be a daunting and arduous task. By Peggy Berry, Pharma Interactive Training Courses, www.phitcourses.com
So now that the long wait is over for the final rule, where do you go from here? On February 8th, 2013 the final rule of the Physician Payment Sunshine Provision (PPSP aka "Sunshine Act") was released by The Centers for Medicare and Medicaid Services (CMS). By Kevin Williams
The contractual and regulatory landscapes are ever-changing, increasingly complex and study timelines just keep getting shorter. By Rebecca Arch
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