INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• Pharmacy Considerations For Early Phase Trials

  This presentation explores practical pharmacy considerations in early-phase clinical trials, offering real-world insights from experienced clinical research pharmacists.

• Definitive QT Evaluation - Clinical And Operational Considerations

  QT strategy decisions affect timelines, cost, and regulatory outcomes. This presentation examines when early QT data can support a waiver, how guidance updates influence study design, and more.

• How Remote Monitoring Is Transforming Compliance

  Discover how remote monitoring is transforming pharmacy compliance. Shift from manual, onsite burdens to digital workflows that ensure real-time accuracy and continuous audit readiness.

• What The Joint FDA And EMA's AI Principles Can Mean For Clinical Trial Technology

  New FDA/EMA principles align global expectations for AI in drug trials, emphasizing transparency, human-centric design, and risk-based governance to ensure data integrity and patient safety.

• A Blueprint For Modern Obesity Research

  5/6/2026

  The landscape of obesity and GLP-1 research has reached a saturation point. To successfully scale to the 5,000-patient registries now required for long-term evidence, a shift in operational architecture is essential.

• Real-Time Data... Are We Fixing The Right Bottleneck (Or Any For That Matter)?

  5/6/2026

  Real-time data streaming to regulators is a bold step, but true clinical acceleration requires solving site-level bottlenecks and data silos to reduce the administrative burden on research.

• Navigating The Waters Of Compliance In Clinical Research

  5/5/2026

  Strengthen your research processes by adopting secure systems, staying current with regulatory standards, and ensuring your team is consistently trained to manage data responsibly and efficiently.

• How To Establish Strategic Readiness For First-In-Human Trials

  4/29/2026

  Most teams realize too late that sequential planning creates delays. FIH readiness depends on aligning IND and clinical strategy early; otherwise, programs risk setbacks that stall execution and timelines.

• US Healthcare System Overview

  4/29/2026

  A clear guide to U.S. coverage, regulation, and reimbursement: who decides care, how products gain access, and how policy and financing shape cost, value, and patient access.

REGULATORY MULTIMEDIA

• Human Abuse Potential: Selecting A Positive Control

  Choosing an effective positive control in HAP studies is critical but not always straightforward. Learn how to justify comparator and dose selection.

• Human Abuse Potential: CSS Interactions

  Learn how, by embedding FDA engagement into the development process, sponsors can strengthen their abuse potential assessment and support smoother regulatory review.

• Pharmacy Considerations For Early Phase Trials

  This presentation explores practical pharmacy considerations in early-phase clinical trials, offering real-world insights from experienced clinical research pharmacists.

• Definitive QT Evaluation - Clinical And Operational Considerations

  QT strategy decisions affect timelines, cost, and regulatory outcomes. This presentation examines when early QT data can support a waiver, how guidance updates influence study design, and more.

• Human Abuse Potential: Subjective Ratings

  Accurate subjective ratings are central to Human Abuse Potential studies. Learn how Visual Analog Scales are administered, what influences responses, and why data collection practices are essential.

• cGMP Compliant Pharmacy

  See how experienced compounding support helps ensure study drugs are prepared accurately and consistently across administration routes, meeting cGMP requirements while supporting clinical protocols.

• Human Abuse Potential: Pharmacy Considerations

  Master the complexities of controlled substance handling, over-encapsulation, and dosing strategies to ensure the data integrity and regulatory compliance of abuse potential assessments.

• Countdown To Compliance: Navigating New UK Requirements

  Senior experts from the HRA, the ISRCTN Registry (BMC), and Quotient Sciences discuss the implications of New UK regulations for clinical trial registration for sponsors and how to maintain compliance.

• Stay Audit-Ready: Practical Compliance Insights For Research Sites

  Gain an auditors insight into common compliance gaps and learn practical ways to strengthen audit readiness in sIRB studies.

• Comparator Selection And Supply: Best Practices For Clinical Success

  Explore best practices for comparator selection and supply optimization in clinical trials, including sourcing strategies, risk mitigation, regulatory compliance, and real-world cost-saving case studies.