INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• A Sponsor's Blueprint For Maintaining Compliance And Ethics In Gene Therapy Trials For Neurological Conditions

  To identify efficacious treatments for neurological conditions, drug sponsors must design ethical clinical trials that protect participants and caregivers while ensuring compliance with regulators.

• Ensure IRB And IBC Success For Your Gene Therapy With Strategic Planning

  To successfully bring innovative gene therapies to patients with neurological disorders, drug sponsors must design safe and compliant clinical trials with rigorous approaches to ethics and consent.

• Empowering Mid-Size Pharma Companies With Integrated Drug Development, Regulatory Strategy, And AI Innovation

  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.

• Is Your Clinical Trial Portfolio CTIS Compliant?

  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?

• 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.

• 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.

• 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.

• 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.

• Automating Regulatory-Grade RWE

  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.

REGULATORY MULTIMEDIA

• Beyond Traditional TRSM: Transforming Clinical Operations At Scale

  Explore how organizations can transform from managing dozens of siloed, protocol-specific RTSM implementations to achieving unified, portfolio-level clinical operations.

• Almac Clinical Leader Solutions Expo September 2025 - IRT

  Complexity is no longer the exception in high stakes clinical trials, it has become the rule.

• IQVIA Technologies Clinical Leader Solutions Expo September 2025 - IRT

  Have you seen an increase in the number of IRT inspections over the past 3 years?

• Patient Centered Research: Challenges And The Role Of HEOR

  This video features expert insights into the evolving landscape of Patient-Centered Research and the role of HEOR in risk-benefit assessments.

• Navigating Disclosure Complexity: The Power Of Human-Centered AI

  Identify key regulatory hurdles that sponsors face when integrating Artificial Intelligence (AI), as well as the impact of AI on clinical trial disclosure and transparency.

• Ensuring Compliance In Gene Therapy Trials: IRB And IBC Views

  Explore ethical and regulatory challenges in neurological gene therapy trials, with expert insights on IRB/IBC collaboration, consent protocols, and oversight for vulnerable populations.

• The New Era Of Project Optimus: Implications For Oncology Development Strategy

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

• Best Practices For Operationalizing Global, Early-Phase Oncology Trials

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

• Navigating What's Next For Global Drug Development: What Sponsors Need To Know

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

• Exploring Ex-US Markets To Reduce Risk For Your Clinical Trials

  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.