Regulatory Insights

1. EU To Measure Trial Results Reporting 11/5/2026

   The EU will publish the share of trials in the Clinical Trials Information System (CTIS) that meet results-reporting requirements, with the first report expected before the end of 2026.

2. Clinical Trial Starts Take Hit From 'Perfect Storm' 11/5/2026

   Clinical trial initiations in 2025 declined 16% versus 2024, reflecting a convergence of regulatory upheaval, funding contractions, geopolitical tensions, and sweeping government restructuring.

3. AI In Informed Consent: What's Your Risk? 10/31/2026

   The more an AI tool writes on its own, the more human review its output demands. Five categories of consent tools carry distinct risks and call for specific documentation.

4. Successful Partnership Advances AML Program To Phase II/III 10/26/2026

   See how strong collaboration rescued a stalled AML study, proved a safer approach to a proven drug class, and turned a Phase I/II partnership into a global Phase II/III trial.

5. Operationalizing Adaptive Design For FDA's One-Trial Era 10/20/2026

   The FDA now accepts one pivotal trial as the default path to approval. Learn how adaptive designs can help you build a single study strong enough to stand on its own.

6. Beyond Healthcare Spending: The Evolving Definition Of Value In Health Policy 10/15/2026

   As pharmaceutical policy takes on more goals, success is harder to define. Value extends beyond spending, requiring evidence that expected benefits are realized.

7. The MDR Paradox: What The December 2025 Easing Takes Off Your Desk, And What You Still Have To Collect 10/14/2026

   The EU’s proposed MDR easing cuts a report, not the duty to collect real-world clinical data. Learn what still applies and how to pick the right post-market evidence method.

8. The PMCF Decision Guide 10/14/2026

   Proposed EU reforms may remove standalone PMCF reporting, yet the duty to proactively collect clinical data remains. Method selection, notified body defense, and data-capture cost determine what comes next.

9. Compliance As A Service (CaaS): Scalable Engagement Model For Evolving Regulations And Technology In Life Sciences 10/14/2026

   Validation demand in life sciences rises and falls with system changes, audits, and deals. A subscription-style compliance model with human-led oversight of AI-enabled systems reframes validation as a standing capability.

10. Preparing Your ERP For Life Sciences Commercialization 10/14/2026

    Operational readiness for commercial launch starts well before approval. Four early decisions about timing, manufacturing model, validation, and partners shape whether clinical-stage systems can carry a commercial business.