Archives: Agenda

• 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.

• How do we look at data transparency issues when scaling AI?
• Case study on AI rights and a look at recently released survey discussing where things need to change
• Without GDPR, what can be done to protect patients regarding data sovereignty?
• Delving into the unique and amplified challenges for AI risk assessment
• How we can effectively leverage AI in our heavily regulated environment?

• Understand key elements of the FDA’s recent directives and their implications for increasing representation in clinical trials
• Review data on the growing emphasis on diversity in sponsor submissions and filings, and learn how to align strategies with industry trends
• Discover practical methods to recruit, engage, and retain underrepresented populations in clinical research
• Examine how prioritizing diversity improves study validity, compliance, and applicability, supported by real-world data

• Gain insights into the complete process of end-to-end financial management.
• Identify the inefficiencies caused by manual steps and siloed technologies.
• Explore how combining services and software can optimize the financial management process.
• Learn how IQVIA Technologies’ expertise and global reach can support your financial management needs, whether insourced or outsourced.

• The evolving landscape of clinical trials and the need for more engaged sites: trial complexity, competition, and site staff turnover
• How the CRO fits into addressing site support as a focal point
• The sponsor’s role in site support
• The road forward: methods of addressing site support