EU-CTR

Overview

In January 2022, the European Union introduced a new Clinical Trials Regulation (CTR), repealing the earlier Directive 2001/20/EC, or CT Directive (CTD). The new EU-CTR regulation aims to harmonize the process of assessment and supervision of clinical trials throughout the EU. All Pharma companies operating in the EU must comply with EU-CTR for all new trials. Each submission requires careful identification of country-specific documents, and a workflow cycle that spans creation through approval.

Challenges with the Submissions Process:

• Limitations of rudimentary tools: Often, the regulatory submission process is executed and tracked using rudimentary tools like Excel, SharePoint, and Email, limiting the flexibility in operations, and leading to lack of efficiency.
• Missing data integration: Lastly, regulatory submissions are often managed by old legacy systems that don’t talk to each other. Manual data management and an outdated user experience causes fatigue and creates data inconsistencies.
• No process transparency: Since a submission request can span multiple countries, rudimentary tools do not provide the visibility into the latest submission status, thereby limiting the regulatory team’s ability to take effective decisions, potentially delaying the regulatory submission.
• Princeton Blue’s EU-CTR solution automates the processing of creating and approving various types of regulatory documents using the Appian Low-code Process Automation technology.

Key Features & Functionality

• The solution orchestrates the entire workflow from document identification to approvals until it is ready to be submitted to the CTIS.
• Automates the identification of Part 1 and Part 2 documents.
• Integrates and extends your existing applications that support regulatory operations to bring data and documents into the context of the process.
• It provides an agile and modern user experience across different devices and form factors.
• Provides insight into the submissions process via interactive graphical dashboards and reports and helps quickly identify and resolve bottlenecks.
• The solution is also easily customized and adapts to your needs.