Bayer shares how they are preparing for EU CTR

This video provides an in-depth exploration of how Bayer, a major pharmaceutical company, is preparing for and implementing the European Union Clinical Trials Regulation (EU CTR). The presentation, led by Julian, outlines the multi-fold implications of the regulation, extending beyond just the submission process to impact various teams such as regulatory affairs, pharmacovigilance, clinical operations, and trial transparency. It highlights the strict scope of the regulation, applying only to interventional clinical trials on medicinal products for human use, and details the significant changes required in document modification, content, and the overall submission strategy.

Bayer's approach involves a complete overhaul of their submission process, including the introduction of a new, dedicated role: the CTIS administrator. This role is crucial for managing interactions with the Clinical Trial Information System (CTIS), especially given the manual nature of data entry due to the absence of an API. The company is heavily leveraging Veeva solutions, specifically Veeva Vault Clinical (internally named "Gemstone") and Veeva RIM (internally named "Brave"), to centralize document management, track submissions, and facilitate rapid information flow to meet the stringent response timelines mandated by the CTR. The discussion emphasizes the shift from a local to a global submission strategy, where a central team defines submission dates and manages the complex interaction with CTIS.

The presentation further details the intricate documentation and information flow envisioned under the EU CTR, with Veeva Vault Clinical serving as the central hub. It explains how various documents—from core part one documents to country-specific part two documents and safety reports—are authored, redacted, and compiled within or uploaded to Vault Clinical. Metadata is crucial for CTIS entries, and a specific strategy for Commercial Confidential Information (CCI) is in place, including deferral requests. The integration of CTMS data with Vault Clinical ensures accurate site information and study event tracking. Ultimately, the compiled submission package is manually extracted from Vault Clinical and uploaded to CTIS, with a copy of the submitted package then archived back in Vault Clinical for eTMF purposes. The reliance on Veeva RIM for tracking submission and approval dates, integrated with Vault Clinical, underscores Bayer's commitment to a unified and compliant regulatory information management system.

Key Takeaways:

• Multi-faceted Impact of EU CTR: The EU CTR is not merely a new submission process; it has profound implications across regulatory affairs, pharmacovigilance, clinical operations, and trial transparency, requiring a holistic organizational adaptation.
• Strict Scope and Timelines: The regulation specifically targets interventional clinical trials on medicinal products in human use, introducing very strict response timelines for requests for information (RFIs), necessitating rapid internal information flow.
• Process Reversal and Centralization: Bayer has implemented a "reversal of the process," moving from local submission packages to a global function that collects documents and data from local organizations, defines optimal submission dates, and manages CTIS interactions centrally.
• New Dedicated Role: CTIS Administrator: A critical new role, the "CTIS administrator," has been created to interact directly with the CTIS. Their responsibilities include managing user permissions, uploading approved documents, monitoring CTIS for RFIs, distributing information internally, and tracking submission/approval dates.
• Leveraging Veeva Ecosystem: Bayer is heavily relying on Veeva solutions, including Veeva Vault Clinical (Gemstone) for CTIS submission preparation, compilation, and eTMF, and Veeva RIM (Brave) for regulatory submission tracking and future document authoring. They also plan to replace their former CTMS with a Veeva tool.
• Manual CTIS Interaction Challenge: A significant challenge highlighted is the lack of an API for CTIS, meaning manual data entry and document upload. This necessitates a robust internal system (like Veeva Vault Clinical) to prepare and organize information for efficient manual transfer.
• Structured Document Management for Compliance: Bayer has modified its document classification to distinguish between protected personal data (PPD) and redacted documents ready for publication, and introduced metadata (CCI tags) to track commercial confidential information, ensuring compliance with disclosure rules.
• Veeva Vault Clinical as Central Hub: Veeva Vault Clinical (Gemstone) serves as the central repository and compilation system for all CTIS documentation and data fields, integrating contributions from various functions and external systems.
• Comprehensive Data Flow Strategy: The documentation flow involves authoring and publication outside Vault Clinical, site-collected documents, CCI strategy documents, safety reporting, and CTMS integration, all converging into Vault Clinical before manual upload to CTIS.
• Archiving and Tracking Post-Submission: After submission, a copy of the CTIS submission package is downloaded and re-uploaded to Veeva Vault Clinical for archiving and eTMF purposes, ensuring a complete audit trail.
• Importance of Metadata and EDLs: Specific metadata fields are used during document upload to mirror CTIS entry requirements, and EU CTR-specific Expected Document Lists (EDLs) are adopted for respective milestones to ensure all necessary data fields are collected.
• Strategic Planning for Submissions: The regulation's rules on dossier modification during ongoing evaluations (e.g., Part One) necessitate a well-defined submission strategy and a clear overview of ongoing study activities, which Veeva dashboards and RIM help facilitate.

Tools/Resources Mentioned:

• Veeva Vault Clinical (Gemstone): Bayer's internal name for their Veeva Clinical Vault, used as the central system for CTIS submission preparation, compilation, document management, and eTMF.
• Veeva RIM (Brave): Bayer's internal name for their Veeva Regulatory Information Management system, used for tracking submission and approval dates, and planned for future document authoring.
• Veeva Workflow: Utilized to manage strict response timelines and ensure quick information flow.
• Veeva Dashboard: Used to provide a good overview of ongoing study activities and submission needs.
• Clinical Trial Information System (CTIS): The official EU portal for clinical trial submissions and interactions, which currently requires manual data entry.
• CTMS (Clinical Trial Management System): Bayer plans to replace their former CTMS with a Veeva solution for managing country and site information, and study events.

Key Concepts:

• EU Clinical Trials Regulation (CTR): A regulation governing the conduct of clinical trials in the European Union, aiming to simplify and harmonize the submission and oversight processes.
• Clinical Trial Information System (CTIS): The centralized online platform for submitting and assessing clinical trial applications in the EU under the CTR.
• Part One & Part Two: The CTR divides the clinical trial application into two parts: Part I (scientific and medicinal product documentation) and Part II (country-specific and site-specific documentation).
• Expected Document List (EDL): A list of documents expected for a specific regulatory submission or milestone.
• Commercial Confidential Information (CCI): Information that is considered confidential for commercial reasons and may require deferral requests for publication under the CTR.
• Protected Personal Data (PPD): Personal data that needs to be protected and redacted before public disclosure.
• Request for Information (RFI): Queries or requests for additional information from regulatory authorities during the assessment of a clinical trial application.
• eTMF (Electronic Trial Master File): An electronic system for managing and storing essential clinical trial documents.