Clinical Data Disclosure, Transparency & Plain Language Summaries 2024

• Practicalities needed to ensure transparency amidst new requirements from EU CTR directive, CTIS implementation and the restart of Policy 0070
• Sharing approach to resourcing, integrating new staff, and vendor solutions to deliver
• Governance and tracking: How can policies and standard operating procedures support delivery of transparency goals?

Tech-Enabled Anonymisation Solutions for Regulatory Documents and Clinical Trial Data

• AI-powered anonymisation for Policy 0070, PRCI, & EU CTR
• Strategic consulting services
• Support for CBI/CCI identification
• Protocol registration & results posting support
• 20 million report pages processed
• 1+ dossiers published by Health Canada or EMA each month
• 80+ EMA Policy 0070 submissions

符合临床试验信息披露要求
Incorporating the Patient Voice into Clinical Trial Summaries

Additional Resources

• RAPS Sponsored Webcast: How to Plan for a Successful EMA Policy 0070 Submission
• Choosing a Clinical Trial Transparency and Disclosure Vendor: Your Complete Checklist
• RAPS Sponsored Webcast: Plain Language Summaries: Understanding the “Why” Behind the Regulations and Guidance