‘Let's Be Ambitious,’ EMA Official Says Of Tackling GDPR Issues In Clinical Trials
The EU clinical trials transformation initiative that was introduced this year could help address the issues clinical trial sponsors face with data privacy legislation, according to a senior EMA official.
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'Pivotal Time For CROs': ICON CEO Cutler On Changing APAC Trial Trends
The CEO of one the global top-five CROs points out a larger opportunity in decentralized trials that might be a “game changer” in the global pharma industry over the next five years. He also refers to the need to accept new technologies by both clinical trial sites and regulators.
Pharma's Clinical Ops Digital Maturity: Patient Experience Tools Lag
Digital maturity of clinical operations at several big pharma firms varies significantly with the gap between best-in-class and the industry average narrowest for site selection tools, recruitment capabilities, and automation, a study has indicated. Digital patient experience tools figure among the least mature capabilities.
EU Aims To Drive Uptake In Decentralized Clinical Trials With Harmonized Guide
The highly anticipated pan-EU recommendation paper on decentralized clinical trials explains the factors that sponsors should consider when designing and implementing such trials.