Regulatory Insights

31. Empowering Mid-Size Pharma Companies With Integrated Drug Development, Regulatory Strategy, And AI Innovation 10/23/2025

    A consultative, tech-enabled CRO can help mid-size pharma achieve targets by supplementing skillsets, expanding global reach, and designing an effective clinical, regulatory, and operational strategy.

32. Is Your Clinical Trial Portfolio CTIS Compliant? 10/21/2025

    The Clinical Trials Regulation and its centralized digital platform, the Clinical Trials Information System (CTIS), are now mandatory. Are you prepared to navigate your next clinical trial in the EU?

33. From Dollars To Debate: Why Clinical Trials Are At A Crossroad 10/20/2025

    Federal funding shifts in 2025 are impacting clinical research, with budget cuts and political scrutiny slowing innovation and threatening diversity in trial participation.

34. What Is ICH GCP, And How Does It Impact Clinical Planning? 10/20/2025

    The updated ICH GCP guideline modernizes clinical trial standards, aligning with today’s technologies to enhance participant safety, data integrity, and risk-based trial design.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.