EU-CTR aims to harmonize the clinical trial assessment and supervision process across EU member states. This regulation has made it convenient for sponsor organizations to keep track of their applications and for regulators to process them more efficiently.
However, navigating the complexities of EU-CTR compliance can be challenging for organizations, particularly when their organization is using manual processes across disparate systems.
Using rudimentary tools like Excel, SharePoint, and email for collaboration can pose challenges including inconsistent data management, lack of process transparency, and more. These can lead to delays, data inaccuracies, and non-compliance in the submission process, ultimately impacting the timely delivery of innovative therapies to patients.
We envision automating the EU-CTR submission process by bringing people and systems together via a unified workflow layer.
A workflow automation solution manages the identification of documents and allows users to add additional documents, as needed, based on the specific requirements of the submission. Once the documents are identified, the solution automatically assigns tasks to the relevant teams for review and finalization. Throughout the workflow, the solution would provide real-time visibility into the status of each document and the overall submission process.
This transparency enables managers to identify potential bottlenecks, reallocate resources if needed, and ensure the timely completion of all tasks. The use of configurable business rules and customizable workflows allows pharmaceutical companies to adapt this solution to their specific regulatory submission needs and processes.
Moreover, the real-time data integration capabilities of a workflow automation platform allows the EU-CTR solution to connect with other systems, such as document management systems and clinical trial management systems. This integration ensures a smooth flow of data and documents throughout the submission process, eliminating the need for people to access data in multiple systems, thus reducing the risk of errors and inconsistencies.
A workflow automation approach for EU-CTR submissions can help sponsors centralize document management, automate the process of creating documents and approving them, and enable seamless integration across data in your existing legacy systems.
This ultimately leads to better process monitoring, greater visibility, efficiency and accountability.
