CTIS Timelines Without the Guesswork: Introducing Regvista's CTIS Assessment Timeline Dashboard
Managing CTIS timelines can be challenging, particularly when multiple submissions, clock stops, RFIs, and modifications are running simultaneously. Discover how Regvista's new CTIS Assessment Timeline Dashboard helps sponsors visualise, track, and manage regulatory timelines with confidence.
CTIS Timelines Without the Guesswork: Introducing Regvista's CTIS Assessment Timeline Dashboard
Since the implementation of the EU Clinical Trials Regulation (CTR), sponsors have benefited from a harmonised framework for clinical trial submissions across Europe through the Clinical Trials Information System (CTIS).
While CTIS has delivered greater transparency and a single-entry submission process, managing assessment timelines remains one of the most operationally challenging aspects of running clinical trials under the new framework.
From initial Clinical Trial Applications (CTAs) to substantial modifications, non-substantial modifications, Requests for Information (RFIs), and clock stops, sponsors are often required to navigate multiple assessment phases simultaneously across an increasingly complex development portfolio.
To help address this challenge, Regvista has developed a dedicated CTIS Assessment Timeline Dashboard, designed specifically to provide sponsors with a clear, intuitive, and visual overview of CTIS assessment timelines.
The dashboard will be made available to sponsors upon request.
Why timeline management matters under CTIS
Successful CTIS submissions require more than regulatory compliance.
They require effective planning, visibility, and proactive management of regulatory milestones.
Missing key assessment dates, underestimating clock stop periods, or failing to anticipate approval timelines can have a direct impact on:
- Study start-up timelines
- Country activation plans
- First patient first visit targets
- Clinical operations planning
- Vendor and site management activities
- Overall development programme timelines
For many sponsors, information exists within CTIS, but obtaining a consolidated view of timelines across multiple submissions often remains time-consuming and operationally inefficient.
A dashboard built specifically for CTIS users
The Regvista CTIS Assessment Timeline Dashboard has been designed with a simple objective:
To transform complex CTIS assessment timelines into an easy-to-understand visual management tool.
The dashboard supports:
Initial Clinical Trial Applications (CTAs)
Visual tracking of:
- Validation phase
- Part I assessment
- Part II assessment
- Requests for Information
- Clock stop periods
- Final decision timelines
Providing a complete view from submission through to approval.
Substantial Modifications
Substantial modifications often involve compressed timelines and multiple rounds of interaction with authorities.
The dashboard allows sponsors to:
- Track assessment progress
- Visualise clock stop periods
- Monitor expected decision dates
- Compare planned versus actual timelines
Helping study teams maintain visibility throughout the modification lifecycle.
Non-Substantial Modifications
Although generally less complex, non-substantial modifications still require oversight and documentation.
The dashboard enables sponsors to maintain a complete portfolio-level view of modification activities and status.
Designed to feel familiar to CTIS users
One of the key design principles behind the dashboard was familiarity.
The visual presentation has been developed to mirror the intuitive experience that sponsors already recognise from the CTIS Sponsor Workspace.
This allows users to quickly understand:
- Current assessment status
- Upcoming milestones
- Elapsed assessment time
- Remaining regulatory timelines
- Overall progress toward approval
Without needing to navigate multiple CTIS screens or manually calculate timelines.
Key dashboard features
Graphical timeline views
Complex assessment activities are translated into clear visual timelines, making it easier to understand where a submission currently sits within the regulatory process.
Clock stop tracking
RFIs and clock stop periods can significantly affect overall approval timelines.
The dashboard provides dedicated visibility of:
- Clock stop start dates
- Clock stop duration
- Restart dates
- Impact on overall assessment timelines
Supporting more accurate planning and forecasting.
Overall time to approval
Sponsors can quickly assess:
- Planned approval timelines
- Actual approval timelines
- Elapsed assessment periods
- Total time from submission to decision
Providing valuable insights for programme management and future submission planning.
Portfolio-level oversight
For organisations managing multiple studies, modifications, and countries simultaneously, the dashboard offers a consolidated view of regulatory activity across the portfolio.
This enables teams to identify potential bottlenecks, prioritise resources, and support proactive decision-making.
Supporting operational excellence under EU CTR
The introduction of CTIS has fundamentally changed how clinical trials are authorised in Europe.
As regulatory processes become increasingly digital, sponsors need tools that not only support compliance but also improve operational efficiency.
The Regvista CTIS Assessment Timeline Dashboard was developed with this objective in mind — helping sponsors move from reactive timeline management to proactive regulatory planning.
By providing clear visibility of assessment milestones, clock stops, and expected approval timelines, sponsors can better align regulatory, clinical operations, and project management teams around a shared understanding of study progress.
Final thought
CTIS has brought significant benefits to European clinical trial submissions, but managing assessment timelines remains a critical challenge for many sponsors.
Visibility drives better decisions.
The Regvista CTIS Assessment Timeline Dashboard provides sponsors with a practical, intuitive solution to monitor submissions, track modifications, understand clock stops, and maintain oversight of approval timelines across their portfolio.
For organisations looking to improve CTIS operational management and enhance regulatory planning, the dashboard offers a powerful new way to stay ahead of key milestones.
Interested in learning more?
Regvista's CTIS Assessment Timeline Dashboard is available to sponsors for a small fee and can be rolled out in no time upon request. Moreover, the dashboard comes with 1 free customisation of your choice.
Contact us to arrange a deployment and discover how enhanced timeline visibility can support faster planning, stronger governance, and more effective management of your CTIS submissions.
At Regvista, we remain committed to support biopharmaceutical leaders navigating their transformative journey—bringing cutting-edge therapies to market faster and safer. Please feel free to contact us by submitting your enquiry to deployment@regvista.co.uk