Regulatory Insights

31. Building A High-Quality IND From Scratch With Strategic Gap Analysis 8/12/2025

    A biotech sponsor lacking in-house regulatory expertise engaged a partner to obtain strategic regulatory review, medical writing, project management, and electronic publishing (eCTD).

32. NDA Success Strategy: Using Non-US Clinical Data In An NDA Submission 8/12/2025

    A sponsor acquiring a therapeutic asset from an overseas company sought assistance when including foreign clinical trial dat,a generated outside a U.S. IND, in a New Drug Application (NDA).

33. Advancing Oncology Innovation With Adaptive Trial Designs 8/12/2025

    When a biopharmaceutical company developing a novel therapy for solid tumor cancers became concerned with rapid over-enrollment from within a single region, they employed a CRO for assistance.

34. Rescuing A Global Program For NDA Success 8/12/2025

    Explore the collaboration that enabled FDA approval of a novel chronic-condition therapy, rescued a high-risk program, and demonstrated a unified “one-team” approach by reworking the sponsor's SAP.

35. 5 Ways To Get Ready For IRT Regulatory Inspections 7/31/2025

    Preparing for a regulatory inspection during a clinical trial can be daunting. Learn about the importance of clear roles, audit trails, data integrity, and training, and get recommendations to help.

36. Managing Risk And Regulation In Clinical Trial Technology 7/31/2025

    Now is the time to evaluate your current risk management framework. Take action today to strengthen your safeguards, tailor your risk assessments, and prioritize transparent patient engagement.

37. AI Maturity In Clinical Development 7/30/2025

    The future of clinical research relies on operationalizing AI in a scalable, sustainable manner, ensuring that both technological and human factors are harmonized in this transformative journey.

38. Comply With The New NIH Transparency Rules For r/sNA Molecule Research 7/30/2025

    Review new transparency requirements for NIH-funded institutions engaged in research involving r/sNA molecules and regulations for Institutional Biosafety Committees (IBCs).

39. Designing "Seamless Phase 1/2" Oncology Trials 7/25/2025

    Selecting a CRO with deep oncology expertise and seamless trial experience is vital to navigate these complexities and deliver transformative therapies to patients faster.

40. Impact Of Data Concerns In Neurological Clinical Trials: Quality Matters 7/15/2025

    This is Part 1 of a 3-part series demonstrating how robust data analytics can address the real-world implications of data quality issues that affect patients waiting for effective treatments.