SUPPORT SERVICES FOR CTIS REGULATION BY ASPHALION

SUPPORT SERVICES FOR CTIS REGULATION BY ASPHALION

Get ready for the implementation of the Clinical Trials information System!

At Asphalion we are pleased to introduce our new services related to the Clinical Trial Information System (CTIS). ASPHALION has been part of the EMA CTIS stakeholder meetings and is also a CTIS Master Trainer, thus we are closely involved in the implementation of the clinical trial regulation (CTR) and CTIS.

To facilitate CTIS uptake and CTR implementation to those needing support we are offering 3 different service packages:

Training: We are providing specific training to pharma and biotech companies in order to guide them through the correct implementation of the new system:

  • Basic training (1h) –Introduction to CTIS and user management
  • Complete training (4h) – CTIS overview and practical cases for Clinical Trial Application submission and clinical trial lifecycle management

Client- tailored consultancy: We can give you support in the definition of your CTIS implementation plan, including:

  • 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

Comprehensive services: Full CTIS training and consultancy package.

We would be glad to help you in case you have any specific doubt or need related to CTIS.

In case you have any further question or if you are interested in our training or service packages, we could organize a short call to discuss how we could help you.

You can contact us at: ctis@asphalion.com

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