INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• The Power of AI To Advance Digital Health Innovation

  Discover how leaders from Pfizer, Mayo Clinic, and the FDA use AI to advance digital endpoints in this 4-video recap of ADDS 2026. Learn to turn AI insights into scalable, regulatory-ready solutions.

• DECODE CRS: Accelerating Immunotherapy Access And De-risking CRS

  How does the DECODE CRS Coalition help trial sponsors standardize protocols and build a first-of-its-kind wearable dataset to lower development costs and safely de-risk outpatient care?

• Navigating The New Landscape Of Oncology Clinical Trials: A Strategic Imperative For Operations Teams

  The oncology landscape is growing but faces high screen-fail rates and trial complexity. To succeed, teams must move past traditional playbooks and adopt centralized pre-screening pipelines.

• Strong Regulatory Foundations For Early-Phase Drug Development

  Discover how an integrated regulatory strategy can help streamline development and accelerate your path to the clinic.

• Regulatory Pathways By Region: A Guide For Early-Phase Trials

  6/17/2026

  Explore key regulatory considerations across major global markets to support more efficient early-phase clinical development planning.

• Financial Compliance In Clinical Trials Explained Clearly

  6/16/2026

  An operational look at financial compliance in clinical trials, explaining how audit trails, traceability, and reporting function under real-world conditions, and why scale makes weak assumptions visible.

• Can Your Trial Payment Approach Stand Up To Regulatory Scrutiny?

  6/15/2026

  Fragmented trial payment systems create compliance, ethical, and operational risks. Aligning payments with regulations and ethics improves transparency, reduces burden, and supports audits and participation.

• Who Decides? Navigating AI Governance in Clinical Research

  6/15/2026

  AI in clinical research poses governance challenges. Clear ownership, consistent policies, and aligned teams help manage risk, ensure compliance, and drive responsible innovation in complex trials.

• Building A Clinical Research AI Governance Framework

  6/15/2026

  Learn how structured oversight, transparency, and collaboration help ensure compliance, reduce bias, and build trust while enabling innovation in increasingly data-driven trials.

REGULATORY MULTIMEDIA

• The Power of AI To Advance Digital Health Innovation

  Discover how leaders from Pfizer, Mayo Clinic, and the FDA use AI to advance digital endpoints in this 4-video recap of ADDS 2026. Learn to turn AI insights into scalable, regulatory-ready solutions.

• Best Practices For Medication Barcoding In Clinical Trials

  Investigational products present a distinctly high-risk environment for labeling and barcoding. Explore best practices for barcoding solutions that allow for improved medication safety in clinical trials.

• Closing The Gaps: Strengthening Safety Data Flow In Outsourced Clinical Trials

  Outsourced clinical trials risk safety missteps when communication falters. Clear, detailed data flow processes help prevent lost context, reduce misclassification, and support more accurate safety decisions across CROs and internal teams.

• AI Meets Informed Consent: Opportunity, Risk, and What IRBs Need to See

  Expert perspectives on IRB oversight, health literacy, and research ethics offer practical guidance to strengthen consent, protect participants, and align compliance with real-world research.

• How To Best Navigate The Global Clinical Trial Registry Ecosystem

  This presentation is your GPS, guiding you on a path that includes harmonization initiatives intended to improve transparency and data consistency across registries.

• 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.