Newsletter | September 19, 2024

09.19.24 -- FDA Under Pressure To Respond To China-Related Clinical Trials Questions

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Oncology continues to lead priority in global drug development. 44% of all Phase I-III trials are tackling oncology. But as the push to combat cancer evolves, so too has the drug development arena. Don’t miss the next Clinical Leader Solutions Expo spotlighting Early Phase Oncology CROs. Live presentations will highlight the key differentiators of each CRO in an interactive forum built for teams no matter where they are in their partner search.

OUTSOURCING MODELS

Dedicated Trialist, Nurse Navigators Help Advance Cancer Therapy To Approval

Thoracic medical oncologist Sally Lau, MD Lau discusses her role as a principal investigator, from the benefits of the FDA’s accelerated approval pathway to best practices for retaining a challenging patient population.

A Best Practice Guide For Laboratory Services In Oncology Trials

Better understand how customizable laboratory services are revolutionizing oncology trials by enabling precision medicine and enhancing patient outcomes through flexible, innovative trial designs.

Mitigating Financial Risk Before Selecting An Outsourcing Vendor

In this presentation, several clinical operations experts delve into the significance of meticulous contract examination when choosing an outsourcing partner.

Better Audits, Faster Through Transparency And Efficiency

Clinical trial audits are evolving. Learn how transparency and efficiency can revolutionize the process, saving time and providing a deeper understanding of operations.

Study Completes Recruitment, Overcomes Pandemic Hurdles

Amid challenges during the COVID-19 pandemic, uncover how recruitment was completed in three countries for a Sweden-based pharmaceutical company's phase 2b study.

How To Take Advantage Of Early Access Programs For The EU

Learn how to leverage Early Access Programs (EAPs) in the EU to expedite market entry for innovative life science products. Gain insights into running successful EAPs, including crucial steps for France.

Biorasi India Is Your Guide To Successful APAC Trials

Witness how Biorasi’s India office has developed into a team of top performers with expertise across all vital components of clinical trial execution.

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Explore the forefront of precision medicine at the Advancing Precision Medicine Conference and Exhibition in Philadelphia, November 1-2. Engage with cutting-edge research featuring experts who are shaping the future of healthcare. Discover new insights into personalized treatments, genomic advancements, and innovative technologies revolutionizing patient care. Expand your knowledge and network with leaders driving the field forward. View the agenda and register today!

REGULATORY & COMPLIANCE

FDA Under Pressure To Respond To China-Related Clinical Trials Questions

The FDA has until October 1, 2024, to respond to several questions regarding concerns about clinical trials conducted in The People's Republic of China. How will their answers affect future trials in China and the sponsors conducting them?

Early-Phase Strategies For Navigating EU Regulatory Complexity

Navigate EU regulatory challenges and position your clinical development program for long-term success by reading our latest insights.

Overcoming The Challenges Of Manufacturing And Clinical Trials

Discover how CROs and CDMOs tackle operational and regulatory challenges for pharmaceutical and biotechnology companies, and how this can be the key to study success or failure.

CMC: Considerations For Small Molecules, Recombinant Proteins

Here, speakers guide viewers through essential questions and real-world scenarios, helping to craft a successful Regulatory CMC roadmap throughout the clinical development lifecycle.

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You're receiving the Thursday edition of the Clinical Leader newsletter, focusing on Outsourcing Models and Regulatory & Compliance. To make changes to your newsletter selections, update your topic preferences.

  • Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
  • Clinical Trial Technology (Tuesday)
  • Decentralized Trials | Trial Management (Wednesday)
  • Outsourcing Models | Regulatory & Compliance (Thursday)
  • Clinical Data Management & Analytics | Trial Monitoring (Friday)

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