The language in clinical trial agreements (CTA) must be very specific to avoid legal problems during the trial, but certain terms have the potential, if not handled correctly, to derail the negotiation process before the trial gets off the ground.
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The word “innovation” is almost synonymous with the word “change,” but the former has a positive feel while the latter can have a negative connotation for risk-averse individuals and organizations alike. With the clinical research industry being both highly risk-averse and in need of innovation, sites and sponsors can benefit from establishing strategies to take the sting out of change.
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In response to requests for more time to weigh in on a pair of long-awaited proposed rules on IRB review and informed consent requirements, the FDA has extended the comment period to Dec. 28.
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Multiple versions of a cell or gene therapy may be studied under a certain type of umbrella trial in which the products being studied are for a single disease, the FDA says in a new final guidance.
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Trials of drugs for pediatric use should train clinical investigators and trial staff to measure and evaluate the drug’s potential impact on participants’ physical growth and sexual development, according to recent FDA draft guidance.
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With a goal of facilitating the seamless exchange of clinical trial protocols, the International Council for Harmonization (ICH) has published draft recommendations for their structure and content.
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The European Medicines Agency (EMA) has answered a multitude of questions from sponsors on its raw data pilot, a program aimed at understanding if submitting and assessing raw data will improve the agency’s review of drug applications.
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