Tag Archives: clinical trials

Clinical Trials

Transitioning EU Clinical Trials: Key Steps for Compliance by 2025

By Diede van Bladel
Clinical Trials

To streamline processes, enhance transparency, and improve the overall efficiency of conducting clinical trials in the EU/EEA, the 3-year transition period from the CTD to the CTR requirements was established. With the end of the transition period approaching, all ongoing clinical trials that were approved under the CTD will have to be fully be transitioned to comply with the CTR. Failure to comply by 2025 will bring serious consequences.

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Harsha Rajasimha, Ph.D.

AI and the Lack of Diversity in Data: Implications and the Path Forward for Rare Disease Research

By MedTech Intelligence Staff
Harsha Rajasimha, Ph.D.

Genomics data scientist Harsha Rajasimha, Ph.D., Founder and Executive Chairman of IndoUSrare, highlights the risks of developing AI/ML algorithms based on biased data, as well as efforts underway to improve global collaboration on the collection and sharing of health data that may help us realize the potential of AI in diagnoses and treatment of rare diseases.

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John Schwope
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The Power of AI to Enhance Clinical Trials

By John Schwope
John Schwope

AI not only improves data collection and analysis, it impacts which products are engaged in clinical trials, determines necessary medical criteria, helps design the trials and can even choose the best participating facilities. The result is, organizations that leverage AI will be more successful and will go to market faster than those that don’t.

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FDA Logo

FDA CDRH To Host Virtual Workshop to Enhance Clinical Study Diversity

By MedTech Intelligence Staff
FDA Logo

The FDA, in collaboration with the Clinical Trials Transformation Initiative (CTTI), is hosting a two-day virtual public workshop on increasing the enrollment of historically underrepresented populations in clinical studies and encouraging clinical study participation that reflects the prevalence of the disease or condition among demographic subgroups. The workshop is scheduled for Wednesday, November 29, and Thursday, November 30, 2023, from 10:00am-2:00pm ET.

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Kaushik Gune

Advancing Digital Health: Huma SaMD Platform Gains U.S. Clearance

By MedTech Intelligence Staff
Kaushik Gune

This week Huma Therapeutics received FDA Class II 510(k) clearance for its Software as a Medical Device (SaMD) platform, potentially speeding approval of a variety of AI and machine-learning (ML)-powered digital health devices. We spoke with Kaushik Gune, U.S. Head of Healthcare at Huma, about the current state of digital health technologies, the value of partnerships to enhance the use of real world data and how digital health is likely to advance in the coming years.

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