INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• AI In Informed Consent: What's Your Risk?

  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.

• Successful Partnership Advances AML Program To Phase II/III

  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.

• Operationalizing Adaptive Design For FDA's One-Trial Era

  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.

• Beyond Healthcare Spending: The Evolving Definition Of Value In Health Policy

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

• 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.

• 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.

• 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.

• 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.

• Cast A Clinical Trial Disclosure 'Net,' Not A 'Line'

  10/13/2026

  In clinical trial disclosure, each country’s obligations are typically treated as separate, isolated tasks. This approach may appear efficient on the surface but can introduce major compliance risks.

REGULATORY MULTIMEDIA

• Operationalizing Adaptive Design For FDA's One-Trial Era

  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.

• Cast A Clinical Trial Disclosure 'Net,' Not A 'Line'

  In clinical trial disclosure, each country’s obligations are typically treated as separate, isolated tasks. This approach may appear efficient on the surface but can introduce major compliance risks.

• Scaling Pharmacovigilance: Clinical Development To Commercialization

  Commercial growth brings new PV challenges. Gain practical insights on operating models, technology, governance, and leadership for long-term success.

• The Future Of Clinical Trials: AI, Real-Time Data, And FDA Innovation

  How does building trial protocols into health records lets key safety and efficacy signals reach sponsors and regulators in days, cutting manual data entry and speeding decisions.

• Cell & Gene Unscripted: Regulatory Affairs

  One platform, multiple payloads: how delivery systems can lower costs and boost access. Parexel experts break down the regulatory data that matters on Cell & Gene Unscripted.

• Cell & Gene Unscripted: Pre-Clinical

  Regulatory modernization is progressing, but harmonization gaps remain. Parexel's Chris Learn & Liz Spehalski dive into pre-IND strategy and precision therapies on Cell & Gene Unscripted.

• The Evidence Gap In Hematology: From Trial Endpoints To Patient Outcomes

  Hematology trials face shrinking patient pools and fierce competition. Discover how real-world data and evidence can sharpen feasibility, site selection, and regulatory strategy.

• A New Chapter for Orexin Therapies: What's Changing in Drug Development

  Join Beatrice Setnik, PhD and Denise Milova, PhD, for a conversation on orexin rescheduling and the evolving regulatory landscape.

• Protocol Builder And Informed Consent Builder Version 2.0

  Built by research compliance experts, this platform streamlines the protocol-writing process through customizable templates, workflow tools, and collaboration support for research teams.

• Protocol Design Choices That Trigger IRB And Regulatory Requirements

  Learn how protocol choices like AI, adaptive designs, and decentralized methods impact IRB review, participant protections, consent, and key regulatory requirements in clinical research.