Optimal Strategies to Protect Commercially Confidential Information (CCI) in Clinical Documents and Report Trial Results Under Revised EU-CTIS Transparency Rules

Revised EU-CTIS transparency rules in European Union (adopted on 18 June 2024) have significantly affected nearly every Sponsor’s decision-making process in consideration of redaction and disclosure activities of clinical information. Sponsors are finding it difficult to prepare both internal and external stakeholders for the demands of this regulation, including:

• consistent authoring and messaging around endpoints reporting,
• targeted redaction or anonymization of confidential information across submission documents throughout the life-cycle of the study, and
• use of the CTIS portal to manage evolving transparency requirements.

In this Expert Insights webinar, MMS will present real-time experience working on EU-CTIS submissions under non-deferral strategies, collating concerns from Sponsor teams, project planning, timelines required, and trends observed in additional redaction criteria for CCI of several in-scope documents. Additionally, MMS transparency experts will share practical scenarios to approach the redaction of documents in CTA, clinical study reports, and reporting of summary results for ‘trial results’ sections for clinical trials.

Watch this Webinar to:

• Learn best practices to be right the ‘first time’ for acceptance of in-scope documents in EU-CTIS submissions
• Gain recommendations on CTIS submission planning, enhancing process efficiency, and liaising with the agency post adoption of revised rules
• Understand real-world scenarios and challenges related to non-deferral strategies, CCI protection, and reporting of clinical trial results

What You Will Learn:

• Revised EU-CTIS transparency rules and how they impact redaction and disclosure activities in clinical documents
• Best practices for devising strategies to protect commercially confidential information (CCI) across clinical submission documents, including anonymization and redaction techniques.
• How to effectively manage and communicate transparency expectations with internal and external stakeholders throughout the study lifecycle
• Practical usage of the CTIS portal to navigate and comply with evolving transparency requirements

Who Will Benefit from Attending?

• Clinical Trial Managers and Clinical Operations Leads responsible for document preparation and submission.
• Transparency Leads and other Regulatory Affairs Professionals overseeing compliance with EU-CTIS transparency regulations.
• Data Privacy Officers and Legal Counsel involved in redaction and anonymization of sensitive information.
• Medical Writers focused on reporting endpoints and trial results.
• Pharmaceutical Sponsors and CROs needing to ensure regulatory compliance and transparency in clinical trials.

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