CRO Analytics and the Association of Clinical Research Professionals are partnering to develop a more holistic approach to clinical trial site quality. Read More

HHS’ Office of Inspector General has added four new projects to its 2015 work plan, including the creation of a Medicare Part D oversight portfolio and a review of states’ reporting on Medicaid rebate collections. Read More

Pharma sponsorship of head-to-head trials comparing two drugs for the same indication may present a serious conflict of interest, a group of American and Italian researchers says. Read More

Sponsors should decrease their use of on-site monitoring in clinical trials in favor of more centralized, risk-based methods that can be largely conducted remotely, an expert says. Read More

While China’s year-old medical device regulations require clinical trials for Class II and Class III devices, there are some exceptions and regulators are in the process of finalizing guidance to help companies take advantage of them, an expert says Read More

The FDA saw an 11 percent increase in inspections carried out as part of a sweeping program to improve inspectors’ understanding of clinical practices during fiscal year 2014. Read More

Drugmakers are getting better at reporting clinical trials results in a timely manner, with only 10 percent of studies on new treatments approved by the European Medicines Agency in 2012 not disclosed within 12 months, a new study shows. Read More

The FDA saw the number of bioresearch monitoring inspections increase 11 percent in fiscal year 2014, to 1,136 from 1,019 in 2013. Read More

A German government agency says the EU’s plan for implementing a clinical trials database lets drugmakers withhold too much information — including study protocols, methods and trial results — under the exemption for commercial confidentiality. Read More

The FDA and Department of Justice are pursuing prosecutions of several international drugmakers, investigators and clinical trials coordinators for conduct and data integrity violations, underscoring the agency’s increasing tendency to treat quality violations as fraud. Read More

Ontario, Canada, is jumping on the centralized-IRB bandwagon with a simplified ethics review program that went live March 4. Read More