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P210: EU CTA Planner (CTAP): A Tool to Plan and Manage EU CTA Submissions and Correspondence in Support of EU CTR 536/2014

Poster Presenter

Christine Barry

Associate Director, Regulatory Operations
Otsuka Pharmaceuticals
United States

Objectives

To develop an automated tool that assists in planning and managing 2-way EMA CTIS submissions and communications for CTA activity via metadata forms and automatic workflows/notifications while capturing audit trail and generating metrics for analytics, budget, and workload management.

Method

Otsuka Global Regulatory Affairs has developed a CTA Planner (CTAP) that manages EU CTA submissions and correspondence to optimize processes, ensure accurate data, forecasting, portfolio transparency, and facilitate CTA-monitoring coverage (CTIS does not generate external notifications).

Results

CTAP is integral in support of EU CTR 536/2014 while planning and managing EU CTAs submissions and correspondence using centralization and automation. CTAP enables EU CTA document planning and metadata compilation by multiple functions within an internal centralized tool prior to uploading in CTIS. This reduces the complexity of user management, which is challenging with multiple CROs, by eliminating CRO need for CTIS access. Automation allows collection of metadata subsets for use in project planning, scheduling, oversight, and metric reporting. CTAP manages submission planning, preparation, quality checks, approval, submission, and archiving. CTAP allows internal contributors as well as external CROs to populate metadata forms that mirror CTIS data and required documents. This centralization provides a single point to manage tasks, including preparing CTIS submission requests; assigning functional areas; providing CTIS data, documentation, and timelines; logging/resolving issues; and tracking submission and document workflow status. Additionally, to overcome the CTIS limitation related to user notifications, each EMA notice / alert is logged and linked to the related CTA submission in CTAP. Automated workflow for the logged notice or alert prompts the relevant functional area to acknowledge awareness and initiate a response if required.

Conclusion

CTAP is an innovative Otsuka global submission tracking and management tool that promotes quality, efficiency, and accountability in the CTA submission process through time-saving features such as automated notifications, tracking and updating workflows, capturing audit trails, and data analytics, all of which allow Otsuka to be one of few companies to immediately operationalize EU CTR upon CTIS going live on 31Jan2022. CTAP generates auto-notifications to contributors and QC reviewers, and also provides status updates for pending and completed tasks. Future CTAP enhancements include CTA progress dashboards, interactive user-friendly metadata e-forms, the ability to request multi-trial submissions such as Annual Safety Reports or CTA Modifications, and use of a distinct timetable for validation, evaluation, and Request for Information (RFI) timelines. The authors wish to acknowledge Boris Reznichenko and Sasikanth Godavarty for support in making this system a reality.