Regulatory Insights

  1. Best Biostatistics Practices To Drive Clinical Trial Success 9/10/2025

    Utilize this checklist of best practices for biostatistics in clinical trials, from early planning to regulatory submission.

  2. The New Era Of Project Optimus: Implications for Oncology Development Strategy 9/10/2025

    In this presentation, expert speakers bring the impact of Project Optimus to life through real-world case studies and practical examples.

  3. Best Practices For Operationalizing Global, Early-Phase Oncology Trials 9/10/2025

    In this presentation, industry experts will share real-world lessons learned from managing global early-phase oncology trials.

  4. Navigating What's Next For Global Drug Development: What Sponsors Need To Know 9/10/2025

    Learn how new FDA initiatives and global regulatory changes can impact your strategy for 2025 and beyond.

  5. Exploring Ex-US Markets To Reduce Risk For Your Clinical Trials 9/10/2025

    How biotech and emerging pharma companies are increasingly leveraging regions such as APAC and Eastern Europe to accelerate trial start-up, secure high-quality data, and optimize costs.

  6. GLP-1 Ocular Safety Monitoring At Point-Of-Need 9/8/2025

    Regulators are sharpening their focus on ocular safety in GLP-1 receptor agonist trials following emerging evidence linking semaglutide to non-arteritic anterior ischemic optic neuropathy (NAION).

  7. Oversight Monitoring In Clinical Trials 9/3/2025

    By engaging early and aligning oversight practices with inspection readiness goals, organizations can protect trial integrity, shorten development timelines, and reinforce patient safety.

  8. Five Questions Biotechs Should Ask Before Selecting A Bioanalytical CRO 9/2/2025

    In a landscape where speed, quality, and trust are inseparable, choosing a CRO that shares your ambition is not optional—it is essential to survival and success.

  9. Accelerating IND-Enabling Studies With Automated Bioanalysis Workflows 9/2/2025

    Reimagined as automation-first, bioanalysis shifts from being an Investigational New Drug (IND) bottleneck to a catalyst for innovation—helping companies move therapies forward with greater confidence.

  10. The Resurgence Of Antibody-Drug Conjugates 9/1/2025

    As advancements in ADC technology and clinical trial methodologies progress, Antibody-Drug Conjugates (ADCs) are poised to become pivotal in precision oncology.