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,...
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Privacy by Design in Global Clinical Trials
Multinational clinical trials are crucial for advancing medical innovation and improving patient outcomes. By including diverse populations, they provide...
What Experts Are Saying About RWD in Clinical Trials
At the 2025 SCOPE Summit Conference, industry leaders gathered to discuss the integration of real-world data (RWD) into clinical...
Synthetic Data: A Real Fix for Clinical Trials?
The industry loves to celebrate synthetic data as a privacy solution—but where’s the real impact? Let’s be clear: privacy...
Move Over Pharma: Patient-Led Organizations Advance Rare Disease Clinical Trials
At the 2025 SCOPE Summit, industry leaders and patient advocates discussed a transformative shift in the pharmaceutical industry: patient-led...
2025 SCOPE Summit: Advancing Patient-Centric Clinical Trials
The 2025 SCOPE Summit brought together industry leaders to explore patient-centric approaches in clinical trials, addressing the critical issue...
Medable’s France CNIL Regulatory Breakthrough: Pioneering Global Clinical Trials
Medable has achieved a significant milestone by securing regulatory approval from France’s CNIL, enhancing its global clinical trial capabilities....
Rakovina’s AI Cancer Treatment Enters Preclinical Trials
Rakovina Therapeutics has received its first synthesized batch of AI-generated ATR inhibitor compounds, developed in partnership with Variational AI....
GDPR and Cross-Border Data Transfers in Clinical Trials
Cross-border data transfers are a critical yet complex aspect in clinical trials. With global collaborations becoming the norm, personal...
Revolutionizing Clinical Trials with AI and Decentralization
In the evolving world of clinical trials, AI and decentralization are key drivers of change. Iddo Peleg, CEO of...