EU Fine-Tunes Guidance For New Clinical Trials System
Industry Still Unclear On Some Key Issues
With a clear implementation date now in sight for the EU Clinical Trials Regulation, the European Commission is focusing its efforts on finalizing additional guidance and templates to support compliance. The pharmaceutical industry wants access to a test version of the new CT portal so that companies can make the necessary adjustments to their own systems.
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Drug companies will be able to “play around” with the new EU Clinical Trials Information System in a secure testing environment before it goes live in approximately 15 months.
The upcoming EU requirement for summarizing clinical trial results in plain language is a real opportunity for companies to engage with the public. But if companies don’t provide clear and concise information, it may be reduced to a box-ticking exercise.
The European Medicines Agency will hold a webinar to explain and demonstrate specific functionalities of the new clinical trials system relevant to clinical trial sponsors.