INSIGHTS ON CLINICAL TRIAL REGULATORY ISSUES

• Blueprint For Efficient Clinical Trial Disclosure

  Explore a comprehensive framework that helps organizations continuously assess and improve their clinical trial disclosure processes.

• How The FDA Is Phasing Out Animal Testing Requirement

  The FDA is embarking on a transformative initiative to phase out animal testing requirements.

• Key Update On Guideline For Good Clinical Practice E6(R3)

  Review details of the adoption of ICH GCP E6 R3 Principles and Annex 1, as well as what preparations and next steps your organization will need to undertake.

• Accelerating Clinical Data Review With Traceable Workflows

  Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

• Tips For Navigating Tax Season As A 1099-MISC Recipient

  4/16/2025

  Explore the tax implications for individuals who received compensation for participating in clinical trials, specifically focusing on the issuance of the 1099-MISC.

• Accelerate Your Oncology Breakthroughs

  4/16/2025

  Finding the right partnership can help your oncology clinical trials overcome trial complexities through strategic planning, a deep scientific understanding, and operational excellence.

• Advancing Rare Disease Clinical Trials: A High-Touch, Patient-Centered Approach For Biotechs

  4/15/2025

  On your journey to developing and executing a successful rare disease trial, it is critical to focus on patient experience and accessibility from the earliest stages of trial design.

• Global Trial Disclosure Landscape Grows Increasingly Complex

  4/15/2025

  The industry is witnessing a global trend toward increased transparency and more stringent enforcement of clinical trial reporting requirements. However mechanisms and penalties differ significantly across regions and countries.

• Accelerate Respiratory Disease Trials: A Guide To Digital Endpoints

  4/15/2025

  Learn how wearables and DHTs are alleviating the trial participation burden, increasing the likelihood of trial success, and enhancing the overall management of these conditions.

REGULATORY MULTIMEDIA

• Blueprint For Efficient Clinical Trial Disclosure

  Explore a comprehensive framework that helps organizations continuously assess and improve their clinical trial disclosure processes.

• Accelerating Clinical Data Review With Traceable Workflows

  Discover how streamlined workflows and enhanced collaboration between data managers and medical reviewers can boost clinical trial efficiency, improve data quality, and ensure patient safety.

• Unlocking Continued Revenue And Growth From Established Products

  Gain insights into how pharmaceutical companies successfully handle post-approval regulatory upkeep for established products, focusing on reducing operational costs and expanding global market access.

• Inspection Readiness For Decentralized Trials

  Decentralized Clinical Trials (DCTs) enhance research inclusivity by minimizing logistical barriers such as travel, scheduling conflicts, and costs, making participation more accessible.

• What Should You Ask The FDA About AI

  Understanding what some of the common questions the FDA gets about AI may help you as you plan to interact with the agency.

• What Is 'Fit For Use' In AI Models?

  The data that you use to train AI models has to be “fit for use” according to the FDA. Tala Fakhouri explains what metrics the FDA uses to make this determination.

• The FDA's View Of AI In Clinical Trials Is Limited

  Tala Fakhouri explains that there could be so many more applications of AI in clinical development than what the FDA sees in regulatory submissions.

• AI In Action: Transforming Clinical Trials

  Tala Fakhouri, associate director for data science and ai policy at the FDA, along with industry consultant Elena “Ella” Sinclair of FlexPoint Bio, talk about common applications of AI in clinical development and the new AI-focused regulatory Guidance from the FDA.

• Navigating The Digital Era And Beyond For Engaging Key Decision Makers In Specialty Pharmacy

  Tune in as experts discuss how biopharma companies can effectively engage healthcare decision-makers in the evolving digital landscape.

• Uncovering The Root Cause Of Clinical Trial Troubles

  Discover essential strategies to prevent clinical trials from reaching a crisis while gaining a deeper understanding of the importance of addressing systemic issues early.