Patient advocacy groups in India are claiming that Bharat Biotech failed to ensure trial participants clearly understood their role in a study of the company’s Covaxin COVID-19 vaccine. Read More
Digital solutions company Vibrent Health has partnered with Eastern Virginia Medical School’s Sentara Healthcare Analytics and Delivery Science Institute (HADSI) and George Mason University (GMU) to launch a national study on the long-term effects of the COVID-19 pandemic to help sponsors and researchers develop and adjust trial strategies for future public health crises. Read More
In its ongoing effort to replace EU clinical trial policies with UK-specific guidance, the Medicines and Healthcare products Regulatory Agency (MHRA) has issued three clinical trial guidances on registering and publishing results of trials, submitting safety reports and making substantial changes to trial applications. Read More
Technological innovation in clinical trials could slow once again as the global health crisis eases and sponsors calculate their return on investment (ROI) for the innovations they adopted during the pandemic. Experts say remote monitoring, telemedicine and the increased use of decentralized trial approaches have proven their worth and are here to stay. Read More
A new accelerated approval program will be available in 2021 to sponsors in the UK under the Medicines and Healthcare products Regulatory Agency’s (MHRA) Innovative Licensing and Access Pathway (ILAP). Read More
Data and analytics company GlobalData has found that the number of resumed trials in the UK and the U.S. has increased from 797 in October to 841 in November, which represents the smallest increase since July. Read More
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