Newsletter | December 4, 2024

12.04.24 -- Defying Industry Setbacks, MindMed Advances Psychedelic To Phase 3

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TRIAL MANAGEMENT

Defying Industry Setbacks, MindMed Advances Psychedelic To Phase 3

Despite the psychedelics industry reeling from Lykos’ recent failed FDA hearing, MindMed is riding high after a positive End-of-Phase 2 (EOP2) meeting with the regulator that has set up the small biopharma for a Phase 3 trial of its LSD-based treatment for generalized anxiety disorder (GAD). 

Treating Deficiencies In Employee Training And Mentorship

Investing in employee training and development is not just beneficial for the employees. It also contributes significantly to the organization’s success and competitive advantage.

Single IRB Review: Tips For Sponsors And CROs

Develop an understanding of the institutional IRB’s role and explore how sponsors and CROs can address the potential impact of mandated sIRB oversight.

How To Design Your Next Diagnostic Study For Success

When it comes to designing diagnostic clinical trials that are modernized, efficient, executable, and cost-effective, explore why there is a strong need to think and plan beyond standard scientific design.

Cognitive, Pharmacodynamic Testing During FIH CNS Trials

A comprehensive review of optimal timing and methodologies for cognitive and pharmacodynamic testing during first-in-human trials on CNS-active compounds.

Successful Special Procedure Study Conduct

Worldwide assisted a trial sponsor with a study focused on cerebrospinal fluid (CSF) analysis to unveil the TP's pharmacokinetic profile and its binding at neuromuscular junctions.

Perceptive eClinical

Learn about a randomization and trial supply management (RTSM) solution helping keep trials on track.

Examining A Phase 1 COVID-19 Clinical Trial

Uncover how we were able to efficiently activate the site and enroll 130 participants within six months, demonstrating our expertise in clinical trial management.

DECENTRALIZED TRIALS

Will Today's Clinical Trial Trends Become Tomorrow's Routine?

Clinical trial trends can be divided into two groups — those related to changes in the conduct of clinical trials and those related to the changes in therapeutic areas. Will these trends hold steady as 2024 unfolds?

New Era Of Increased DCTs Shows Promise For Site Success

DCTs are increasingly popular, but they’re often underutilized. What steps can sponsors take to ensure that their DCTs are successful? The answer: build positive relationships.

Beyond the Checkbox: Rethinking Your Cardiac Monitoring Approach

A modernized approach to cardiac monitoring is essential for the dynamic nature of contemporary clinical trials, which demand flexibility, remote capabilities, and real-time data access.

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