CTIS Training
& Tailored Consultancy
Part of the EMA CTIS stakeholder meetings
CTIS
Master Trainers
Highly qualified consultants
CTIS related services
All Clinical Trials starting in the European Union have to comply with CTIS Regulation and be conveyed through the Clinical Trial Information System (CTIS) as the common portal, aimed at homogenizing and standardizing the process across the EU.
To facilitate CTIS uptake and CTR implementation to those needing support Assphalion is offering 3 different service packages:
BASIC CTIS TRAINING
- Introduction to the Clinical Trial Regulation No 536/2014
- CTIS overview
- CTIS User access management
- Conclusions & Recommendations
TAILORED
CONSULTANCY
- Evaluation of clinical trial workflow and procedures to adapt to new CTIS functionality and day-to-day use
- Identification of strategies and planning for the transition period of existing and/or new trials
- Identifying local requirement needs in addition to centralise CTIS functions
- Transparency requirements and strategy
- Ad hoc consultancy
FULL CTIS TRAINING
- Submission of an initial Clinical Trial Application in CTIS
- Creation, submission and withdrawal of a CTA
- Search, view and download information on clinicaltrials and clinical trial applications
- Update of an initial CTA
- Submission of trial results and layperson summary
- Transparency – publication of clinical trial information
- Work-planning and management tools
Meet our CTIS reference expert:
Christopher Mann, PhD
Scientific and Regulatory Affairs Director
Christopher has a PhD in Biochemistry (Molecular biology) in gene therapy for muscular dystrophy.
He has been an academic researcher in gene therapy, muscle regeneration and muscular dystrophy as well as diabetes for 15 year and has published numerous original research papers and review articles in peer reviewed journals.
He is also an expert in medical and scientific writing for Advanced Therapy Medicinal Products (ATMPs), Biosimilars, Biological, Biotechnological and other Innovative products, and has also additional expertise in pediatric development (EU and FDA), Scientific Advice/ Pre-IND meetings and Centralized Procedures.
He has also been work package leader for several research consortia, including projects with ATMPs.
“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 1,000 Pharmaceutical, Biotechnological and Medical Technology companies from more than 50+ countries in over 5,000 projects covering non-clinical and clinical development, CMC, dossier writing, regulatory procedures, vigilance, eSubmissions and data management for both medicinal products and medical devices.
Quality
Memberships
