CTIS Management
& Tailored Consultancy
ASPHALION actively participates in EMA CTIS stakeholder meetings, ensuring our close involvement in the implementation of the Clinical Trial Regulation (CTR) and the Clinical Trial Information System (CTIS).
Part of the EMA CTIS stakeholder meetings
CTIS
Master Trainer
Highly qualified consultants
CTIS related services
All Clinical Trials in the European Union have to comply with the Clinical Trials Regulation and be managed through the Clinical Trials Information System (CTIS) as the common portal, aimed at harmonizing the process across the EU.
To facilitate CTIS uptake and CTR implementation to those needing support Asphalion provides three different types of services:
Personalized training programmes
- Basic training (1h)
Introduction to Regulation (UE) 536/2014 and CTIS main functionalities. - Full training (3h)
Detail on CTIS procedure management and doubt solving.
Technical and operational support
- User registration and access permissions.
- Management of clinical trials throughout their life-cycle:
- Preparation and submission of a clinical trial application (CTAs).
- Substantial and Non-Substantial modifications, as well as addition of new Member States.
- Management of notifications/events.
- Daily monitoring of notifications and alerts.
- Annual Safety Reports and Trial Reports.
TAILORED CONSULTANCY
- Assessment of workflow and procedures to be adapted to new CTIS management.
- Support on the identification of local requirements.
- Strategy and management of transparency requisites.
- Ad-hoc consultancy.
Meet our CTIS reference expert:
Nuria García Pazos
Regulatory Affairs Senior Consultant
Nuria García Pazos holds a degree in Biotechnology and three master’s degrees focused on Neuroscience, Pharmaceutical Industry, and Regulatory Affairs.
Experienced professional in Regulatory Affairs within the pharmaceutical industry since 2018, with a strong focus on clinical trial regulation, regulatory strategy, and project management. At Asphalion, she has progressively held roles of increasing responsibility, currently serving as Senior Regulatory Affairs Consultant.
Nuria is an expert in the implementation of the Clinical Trials Information System (CTIS), clinical trial applications in the EU, and the transition to the EU Clinical Trials Regulation (CTR). She also has deep expertise in clinical data disclosure, national and international regulatory procedures (DCP/MRP, NP, RoW), regulatory texts and promotional material review, and coordination with health authorities and global partners.
Her multidisciplinary background and practical regulatory insight make her a valuable contributor to complex international projects.
“We are proud to have been able to actively participate as a stakeholder in CTIS implementation.
We are in a position to offer detailed guidance to clients including different levels of training and advice.”
Schedule now a free meeting with our CTIS experts!
Tell us about your project, challenges or doubts. We will be happy to assist you!
Why Asphalion?
ASPHALION offers expert consulting, strategic advice, operational support and full outsourcing services for all drug development stages
ASPHALION’s experts have delivered solutions to over 1,500 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50+ countries in over 10,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices.
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