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Drugmakers are increasingly using joint ventures and research consortia to accelerate early stages of drug development and share the burden of cost, according to Deloitte. Read More
The European Medicines Agency is seeking applications to join a multidisciplinary team to help the agency develop best practices for the anonymization of clinical reports. Read More
The European Medicines Agency published a draft proposal to accept measurements of fibrinogen as a biomarker to identify chronic obstructive pulmonary disease patients for inclusion in clinical trials. Read More
The European Medicines Agency is seeking applications to join a multidisciplinary team to help the agency develop best practices for the anonymization of clinical reports. Read More
The U.K.’s Information Commissioner’s Office published a draft guidance on obtaining informed consent, ahead of stricter European Union regulations on data protection that take effect in May 2018. Read More
An NIH center announced that all clinical trial sites participating in its grant program have agreed to use a single institutional review board for each multi-site study. Read More
Pharmaceutical companies and clinical research organizations are seeking greater clarity in an FDA draft guidance covering clinical trials with multiple endpoints. Read More
Last year’s 21st Century Cures Act directed federal agencies to pursue an international pediatric clinical trials network, and to engage with foreign regulators alongside attempts to align international guidance. Read More