Asphalion launches CTIS support and training programme

ASPHALION has been part of the EMA CTIS stakeholder meetings and is also CTIS Master Trainer, thus is closely involved in the implementation of the clinical trials regulation and ready to help any client who may need training and consultancy, contributing its 21 years’ experience. 

As Dr Christopher Mann, Scientific and Regulatory Affairs Director says, “We are proud to have been able to actively participate as a stakeholder in CTIS implementation and be in a position to offer detailed guidance to clients including different levels of training and advice that covers procedures, workflows to map CTIS functionalities and day-to-day use, strategic advice and planning for the transition period and identifying local and transparency requirements”.

CTIs will go live when the Clinical Trial Regulation (CTR) 536/2014/EU becomes applicable on January 31st, 2022, and it will repeal the existing Clinical Trial Directive 

2001/20/EC and national legislation that was put in place to implement the Directive. Companies will have to face many changes regarding CTIS. The harmonisation of the submission requirements and assessment processes of clinical trials conducted in the EU will allow a robust and agile approval process and a close coordination between Member States for multi-country trials.

CTIS will be a unique digital tool for harmonised submission, evaluation and supervision of clinical trial applications (CTAS) in the European Union, as well as allowing a fully electronic exchange of information between sponsors and Member States over the life cycle of a clinical trial.

An important point to take into account is that almost all documentation for the entire life cycle of the trial stored in the database and will be publicly available, unless exempt according to Article 81(4) of CTR.

Enhanced patient safety will be provided for by simplifying safety reporting and through a coordinated assessment of Suspected Unexpected Serious Adverse Reactions 

(SUSARs) and Annual Safety Reports (ASRs).In case you have any further questions related to CTIS you can contact: ctis@asphalion.com

About us

ASPHALION is an international Scientific and Regulatory Affairs consultancy company with offices in Barcelona, Madrid, Munich and London. Founded in 2000, ASPHALION has grown consistently and currently employs over 130 team members of over 10 different nationalities. Its strong track record has made ASPHALION a reference in the international healthcare sector and a key stakeholder in the implementation of new regulatory standards. 

ASPHALION’s experts have delivered solutions to over 900 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50 countries in over 4,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices. 

ASPHALION offers strategic advice, expert consulting, operational support, as well as full outsourcing services for all types of products in all therapeutic areas. To deliver the best possible solution in each project, ASPHALION works closely with international competent authorities, notified bodies, scientific associations and key opinion leaders and maintains a comprehensive network of geographic and functional partners