Archives: Agenda

• Trends observed during the JP Morgan Healthcare conference
• The impact of the new administration on clinical trials

• How independent adjudication improves endpoint accuracy and consistency in trials.
• Ways adjudication improves data accuracy and regulatory compliance.
• Strategies to reduce risk and streamline trial timelines.
• How to reduce variability and disputes in clinical endpoint assessments.

• Evolution of CRO FSP models
• Balancing growth and quality in a hybrid model
• The future of scaling and offshore integration

• Prioritizing your organizational structure and goals
• Key considerations for developing a bespoke outsourcing framework
• Building resilient outsourcing strategies that align with future clinical development needs

• How to create a patient-centric clinical protocol to obtain the necessary data and validate your primary objective
• How biotechs are using tools internally and managing different stakeholders to pressure test themselves to have less complicated protocols
• Looking at ways to ensure patients don’t go through a burdensome process
• Championing collaborative sites for a streamlined trial

• Understanding UDI requirements across regions
• Implementing UDI systems for traceability and safety
• Leveraging UDI data for operational efficiency

• Automating Adverse Event Evaluations: Enhancing speed and accuracy using AI.
• Streamlining Clinical Protocol Training: Efficiently generating consistent training materials with AI.
• Improving Medical Coding: Utilizing AI for accurate adverse event classification and regulatory compliance.
• Reducing cycle times and operational costs and enhancing data accuracy to
  better clinical trial results

Japan, as do other countries, has unique characteristics that are often difficult to understand from an outsider’s perspective. These differences include not only pharmaceutical regulations and medical systems but also customs, culture, and language. Despite efforts toward global harmonization, the distinctiveness of each country, shaped over many years, still persists. This guide serves as your ultimate resource for navigating the complexities of conducting clinical trials on a global scale, including Japan.

• Understanding key factors for conducting drug development in Japan
• Analyzing the challenges of drug development in regions with less visible dynamics, using Japan as a case study.
• Exploring solutions to maximize the probability of success in drug development.