The FDA has extended its agreement with CluePoints to augment the agency’s oversight of clinical trials using data-driven approaches, with additional testing ideas focusing on moderators of treatment effect and real-world evidence, says CCO.
Arkivum to create an e-archive for Idorsia to store and manage its large amount of data regarding products returned from CROs, after the latter’s separation from Actelion.
Two US Attorney Generals have opened an investigation into the data breach at AMCA that compromised a combined nearly 20 million patients at LabCorp and Quest Diagnostics – as the companies’ efforts to notify the public are called into question.
Hu-manity.co acquires Betterpath in a deal that will see both patients and pharma gain access to some 80% of health care’s “dark data” – information that comes with explicit consent under fair trade practices, which is not only a good ethical posture,...
An international coalition of health integrity groups today demands that European universities must make clinical trial results public – with 83% all of due trials still unreported, according to a new report.
The EMA needs to fix problems with the clinical trial registry to improve reporting across Europe, says TranspariMED founder, as seemingly small issues can “seriously hinder compliance.”
The UK Parliament is putting pressure on universities failing to publish data from clinical trials – with plans to question institutions later this year following a debrief with AllTrials, which will be monitoring compliance.
Global regulatory agencies had a busy 2018. Here, we take a look back at some of the key developments throughout the year, as the industry navigated challenging politics, pressure to increase transparency, and the rapidly evolving digital health space.
The Pistoia Alliance hopes to facilitate “seamless data integration” between various industry stakeholders, including life sciences companies and CROs, via an open and freely available data format.
