The EU has announced a new regulation - number 536/2014 - for clinical trials, which is planned to come into force not before 28th May 2016. It is an important step because it sets out the requirements for a single clinical trial approval portal and the content of clinical trial applications to be standardized.
Today, Veeva Systems unveiled the results of its 2015 Paperless TMF Survey: Annual Report. The survey is in its second year, and as Jennifer Goldsmith, vice president of Veeva Vault, told Applied Clinical Trials, it was interesting and significant to report on the year-over-year results.
Forging new partnerships focused on the safety of long-acting opiates is important, as public health questions surrounding drug abuse and addiction have increased, along with regulations governing these products once they reach the market.
Merck & Co. Chief Medical Officer Dr. Michael Rosenblatt speaks with Applied Clinical Trials about the significant opportunities and challenges of sharing clinical trial data and the progress so far in developing a framework that, if properly pursued, could help transform the future of research and clinical care.