INSIGHTS ON CLINICAL TRIAL DESIGN

• Strategic Implications Of The Single Phase 3 Approval Paradigm

  As FDA single-trial approvals gain traction, CNS developers need stronger early evidence. Learn how biomarkers, patient selection, and regulatory strategy can accelerate development.

• How Some Patient Organizations Are Driving Drug Development

  Discover how patient-led registries are becoming a practical source of real-world evidence, drug repurposing insight, and smarter trial design.

• Effective Study Design And Execution Of Renal And Hepatic Impairment Trials

  Master the complexities of renal and hepatic trials by leveraging site expertise and PK modeling to navigate recruitment challenges and ensure precise dosing for impaired populations.

• Combination Therapy Dose Optimization In Oncology Trials

  Optimize dose selection in oncology trials by moving beyond toxicity limits. Use advanced modeling and benefit-risk analysis to improve efficacy and meet modern regulatory standards.

• Optimizing Pharmacokinetics In Clinical Development

  8/24/2026

  PK tools can do more than model drug behavior — they shape smarter trial designs, better dosing decisions, and lighter burdens on patients. Here's how.

• Finding The Solution(s) That Meet Patient, Site, And Sponsor Needs

  12/4/2025

  Poor enrollment and retention often stem from patient burden and limited site access. Learn how leveraging diverse site networks and remote support can transform the clinical trial experience.

• Overcoming Barriers To Participation

  11/22/2024

  Explore effective strategies to enhance diversity and inclusion in clinical trials by supporting underrepresented patient groups, ensuring equitable health outcomes and broader representation.

• Pioneering Clinical Research For Native American Communities In South Dakota

  1/31/2025

  Lynn Bartholow is transforming clinical research for Native American populations. Explore her journey into clinical research and efforts to build trust and foster participation and community engagement.

• RWD, New Technologies Show Potential In Clinical Trial Recruitment

  7/10/2025

  Leveraging RWD transforms feasibility and recruitment from reactive processes into strategic drivers of clinical trial success.