INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• Five Ways To Get Ready For IRT Regulatory Inspections

  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.

• AI Maturity In Clinical Development

  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.

• Comply With The New NIH Transparency Rules For r/sNA Molecule Research

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

• Designing "Seamless Phase 1/2" Oncology Trials

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

• 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.

• Analytics–Powered Approach To Patient Recruitment Strategy

  7/15/2025

  In a Phase 3 psychiatry trial, a pharmaceutical company partnered with Signant to revolutionize patient recruitment through data-driven site selection using PureSignal Analytics.

• Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress

  7/15/2025

  Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.

• Controlling Comment Chaos: A Medical Writing Leader's Story

  7/14/2025

  Discover how Sarah Wilson, Director at Alkermes, revolutionized document collaboration using a document review platform to boost efficiency and overcome regulatory challenges in medical writing.

• Strategies For QA Professionals In Life Sciences

  7/14/2025

  Explore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.

REGULATORY MULTIMEDIA

• The 3 FDA Oncology Approvals That Will Have The Biggest Impact In 2025

  The FDA wrapped up 2024 with 3 notable approvals. Harpreet Singh, MD and CMO, provides a recap.

• The FDA's New Guidance May Be Shaking Up Biotech

  The FDA’s recent draft guidance on accelerated approval outlines tougher standards for confirmatory trials and introduces a faster process for withdrawing approvals.

• All You Need To Know About 505(b)(2), But Were Afraid To Ask

  Join us to explore the 505(b)(2) pathway. Learn how to bring improved drugs to market faster, reduce costs, and add value with this streamlined regulatory approach.

• Regulatory Advantages Of Clinical Trials In Canada Versus Australia

  An expert answers your question about the regulatory advantages of conducting your clinical study in Canada versus Australia. Watch now to learn more.

• Drug Price Controls: What Are The Unintended Consequences To Innovation?

  Review the ripple effects of drug price controls, including recent U.S. policy shifts like the IRA and President Trump’s Executive Order introducing International Reference Pricing.

• Controlling Comment Chaos: A Medical Writing Leader's Story

  Discover how Sarah Wilson, Director at Alkermes, revolutionized document collaboration using a document review platform to boost efficiency and overcome regulatory challenges in medical writing.

• Strategies For QA Professionals In Life Sciences

  Explore challenges QA professionals face in document reviews and expert strategies to boost accuracy, streamline workflows, and ensure compliance with evolving regulatory standards.

• Navigating Regulatory Uncertainty: Diversity Action Plans

  Sponsors planning Phase 3 and pivotal clinical trials are facing fresh uncertainty as the FDA’s Diversity Action Plan guidance continues to shift.

• Mitigating Risk With Ex-U.S. Clinical Trials

  Gain insight into why certain regions offer strategic advantages, from regulatory flexibility to faster enrollment, and how to effectively integrate them into your development strategy.

• Planning Your IND: When And Why To Engage The FDA

  This presentation explores how and when to initiate IND activities, highlighting that sponsors can strategically open an IND to access FDA guidance and enable U.S. clinical trials.