Drug companies in the EU are keen to devise and validate digital endpoints, but they want regulators to simplify the current complex environment around the process, find pragmatic solutions and issue guidance that can help move the field forward and offer more clarity.
EU Pharma Wants Regulators’ Help To Simplify Digital Endpoints Landscape
The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.
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The EU Clinical Trials Information System has achieved primary registry designation in the International Clinical Trials Registry Platform in a move that is expected to reduce regulatory burden for companies and help them lower compliance costs by aligning with publication requirements in medical journals.
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