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TransCelerate BioPharma Inc.

Latest From TransCelerate BioPharma Inc.

Risk-Based Monitoring: US FDA Clarity And Industry Standards Aren't Enough

Only a culture shift can move sponsors away from traditional monitoring to risk-based approaches, a transition being slowed by fear of change as well as confusion resulting from too many ‘flavors’ of risk-based monitoring strategies, stakeholders say; FDA tries to clarify what risk-based monitoring is, and is not.

Clinical Trials Compliance

Patient Engagement In Clinical Trials Needs More FDA Guidance, Stakeholders Say

Industry urges US FDA guidance on developing plain language summaries, which could help improve the release of clinical trial results to patients. 
Clinical Trials Research & Development

Digital Transformation Of Clinical Trials Is Shared Responsibility, CRO Industry Says

Digitizing data collection and monitoring has taken longer than desired due to various challenges, including resistance to change, unanticipated burdens and trial complexity, officials from ACRO and Medidata say, countering US FDA Commissioner Gottlieb’s criticisms that CRO business practices are holding back change.


Clinical Trials Digital Health

Reliance On ‘Digitized Paper’ Is Slowing Drug Development – US FDA’s Woodcock

Efficient development and review is being hindered by the inability to exchange data freely and truly capitalize on the digital age, CDER director says, challenging industry, regulators and others to creatively think about how to move away from legacy, paper-based processes in clinical trials and regulatory submissions.

Clinical Trials Drug Review
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