WHITE PAPERS & CASE STUDIES

• Off-Script FDA: How Smart Teams Pivot, Escalate, And Progress

  Dr. Rachel Sherman, former Principal Deputy Commissioner of the FDA, explains the rules of engagement for working with today’s FDA.

• The Rescue Option: Course Correcting Struggling Clinical Trials

  The willingness to seek expert support from Rescue CROs when clinical trials face critical challenges is not a sign of weakness but a demonstration of accountability and commitment to excellence.

• Spotlight On India: Regulatory Enhancements, Modernization, And Robust Data Collection

  Explore India's adoption of global best practices, 24/7 work cycles, and audit readiness to ensure high standards of Good Clinical Practice, attract more trials, and provide robust data to stakeholders.

• Patient Diversity: Identifying Challenges, Opportunities, And Best Practices

  By listening to the voice of patient diversity and implementing FDA guidance measures, learn how stakeholders can improve trust, engagement, data reliability, patient outcomes, and promote public health.

• Consider India For Your Next HCC International Trial

  Assess the feasibility of India as a potential venue for HCC trials as well as its epidemiology, historical perceptions, and untapped potential for international clinical research opportunities.

• Elevated Risk: Exploring The Links Between Chronic Kidney Disease And Cardiovascular Disease

  Chronic kidney disease has become inextricably linked with cardiovascular conditions, a discovery that has yielded synergistic diagnosis and intervention methods. Dr. Jamie Dwyer explores the connection between these two diseases, which has brought about a sort of renaissance for nephrology research.

• No Shortcuts: Two Pathways To Building A Future For Huntington's Disease Research

  One of the tenets of clinical research is that findings often result in more questions than answers. For Huntington’s disease, the journey toward understanding and treatment continues to be a methodical one. Dr. Ole Isacson highlights two pathways to ongoing research for this rare disease.

• The Missing Minority: Understanding The Three Main Barriers To Diversity In Today's Clinical Trials

  While there are socioeconomic factors contributing to the reasons behind the lack of diversity, the exclusion of minority populations in clinical trials can be a scientifically flawed misstep. By focusing on a single demographic, clinical research findings become limited, and by ignoring other representative populations, "unexpected" side effects may be more commonplace while treatment success levels will vary.