Regulatory Insights

41. Clinical Trial Disclosure Noncompliance: What Is Its Impact On Pharma M&As? 10/20/2025

    Noncompliance with clinical trial disclosure regulations can jeopardize M&A deals. Understanding FDA and SEC requirements is critical to avoid red flags during due diligence.

42. The EMR Interoperability Dream Vs. Clinical Research Reality 10/20/2025

    Seamless Electronic Medical Record access promises accelerated trials and regulatory-grade evidence, but incomplete, unstructured data requires hybrid strategies using AI and human oversight to bridge gaps.

43. Automated Evidence Generation For Regulatory-Grade RWD 10/20/2025

    Global regulatory agencies increasingly adopt Real-World Evidence, demanding higher data quality and automated AI-driven platforms to meet evolving standards and improve drug development pathways.

44. Why Asia Should Be Your Next Trial Destination 10/17/2025

    Many U.S. oncology sponsors are expanding their late-phase trials into Asia to secure access to rich patient pools, leverage efficient regulatory pathways, and save time and money in the clinic.

45. Top 5 Challenges In Psoriasis Trials (And How To Overcome Them) 10/15/2025

    Psoriasis trials face recruitment, endpoint, regulatory, and operational challenges. Identifying common hurdles early helps sponsors streamline processes, avoid setbacks, and prevent costly delays.

46. Conducting Early Phase Clinical Trials In Diverse Healthy Populations 10/14/2025

    Download our guide to learn proven strategies for designing early phase clinical trials that successfully enroll diverse populations and meet FDA diversity guidance.

47. Key Takeaways From ADCs In Oncology Trials Webinar 10/2/2025

    By aligning cutting-edge design with evolving regulatory expectations, sponsors can unlock the full therapeutic potential of ADCs and deliver transformative cancer treatments to patients worldwide.

48. Validation Beyond Just Meeting FDA Requirements Is Crucial 9/30/2025

    As the U.S. FDA is impacted by layoffs that threaten its oversight capabilities, the importance of robust software and manufacturing process validation has never been more critical.

49. Rapid Startup Phase 1 Cardiomyopathy CRISPR Gene Therapy 9/25/2025

    Hereditary transthyretin amyloidosis (ATTRv) is very rare, prompting a Phase 1 trial of in vivo CRISPR/Cas9 gene editing to reduce mutant protein and stop cardiomyopathy progression.

50. Conducting Autologous Cell Therapy Research With Zero Sample Loss 9/25/2025

    Autologous cell therapy trials require precision at every stage—and this biomarker-specific solid tumor study exemplified the challenge.