Measuring What Can't Be Seen: How PTSD Clinical Trials Prove a Drug Works
When an oncology drug is tested, the signal is often brutally clear. A tumor either shrinks on a...
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Strategic Consulting
The Psychedelic Setback: What MDMA Rejection Taught Drug Developers
In August 2024, the FDA declined to approve MDMA-assisted therapy for post-traumatic stress...
EU Pharma Package: Key Takeaways for Clinical Evidence & JCA Strategy
Following the political agreement of 11 December 2025 on the EU Pharmaceutical Package, the summary...
Preserving What Matters: How Institutional Knowledge Protects Value Through M&A
Mergers and acquisitions (M&As) are a defining feature of today’s biopharmaceutical landscape. As...
ASH 2025: Interpreting Rapid Change Across Hematology
Returning from the American Society of Hematology Annual Meeting in Orlando, one message was clear:...
IND Success Strategy: Building a High-Quality IND from Scratch with Strategic Gap Analysis
Learn how our regulatory affairs team was able to work with a sponsor to build a complete,...
NDA Success Strategy: Using Non-US Clinical Data in an NDA Submission
When our sponsor acquired an investigational asset from an international company, they faced a...
On Track and in Sync: How Veristat Continues to Support Efficient FDA Interactions
In today’s regulatory climate, ongoing discussion about FDA workload, funding constraints, and...
Cross-Functional Collaboration: A Cornerstone of Successful Clinical Development
Complex therapeutic development requires deep integration across clinical, regulatory, statistical,...
Project Optimus Explained: Why the FDA is Shifting Away from Maximum Tolerated Dose in Oncology
Historically, oncology drug development followed a straightforward principle: identify the highest...