Guided, Then Penalized: A Deep Dive into the FDA’s MDMA Ruling and What it Means for Psychedelic Clinical Trials
In August 2024, the FDA rejected the New Drug Application for MDMA-assisted therapy for PTSD, sponsored by Lykos Therapeutics,...
How FDA’s Guidance on Decentralized Trials Applies to Community-based Research Execution and Compliance
In September 2024, the U.S. Food and Drug Administration (FDA) issued its final guidance titled Conducting Clinical Trials with Decentralized...
Did the FDA Just Redefine Real-World Evidence Without Telling Anyone?
Real-world evidence (RWE) is increasingly referenced in regulatory conversations, particularly following the FDA’s 2023 guidance. Roche’s recent FDA clearance...
Pragmatic Trials? All Talk, No Real Progress
Pragmatic clinical trials have become one of the industry’s favorite buzzwords, but where’s the real progress? Every year, the...
The Emergence of Superintelligence in Healthcare, Biotech, and Clinical Trials
The journey toward superintelligence unlocks extraordinary capabilities poised to revolutionize medicine and healthcare. These systems can process vast amounts...
How The Trump Administration Will Impact The Future of Clinical Trials and Biopharma
The re-election of Donald Trump in 2024 marks the start of a dramatic transformation in healthcare, biotech, and clinical...
Walmart Health Center Exit: Is It Good For Clinical Trials?
This article contains speculative content, opinions, and assumptions about the Walmart Health center that are not confirmed facts. The...
How Practical Is FDA’s HCP Approach in DCTs?
The FDA’s latest guidance on Decentralized Clinical Trials (DCTs) marks a pivotal shift in the clinical research landscape. This...
DCTs and Secrets To Securing Wearables Data
Decentralized Clinical Trials (DCTs) are pioneering a shift towards a more patient-centric approach in clinical research by leveraging the...
CRO Performance: A Forgotten Voice of The Site’s Perspective
Contract Research Organizations (CROs) and vendors stand as pillars in clinical trials, with sponsors thoroughly building Key Performance Indicators...