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Post-Trial Access (PTA) is more than an ethical obligation—it’s a strategic opportunity to demonstrate patient commitment, extend treatment benefit, and
Expanded Access Programs (EAPs), sometimes known as Managed Access Programmes (MAPs), allow pharmaceutical sponsors to offer patients their pre-approval investigational
This joint blog between Cisiv and Boyds discusses the strategic reasons for collecting real world data (RWD) alongside expanded access
Recorded: 5 October 2023 An expanded access programme is a legislative framework, used by both the European Medicines Agency (EMA) and the Food and
For years, the prospect of ‘virtual’ and decentralised research was discussed with hope as a potential disruptor to enable greater
We have recently seen a surge in real world data (RWD) collection alongside expanded and managed access programmes (EAP and
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