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Early Access Programs
European Early Access Programs (EAPs) offer sponsors a means of providing patients with access to innovative developmental drugs on compassionate grounds, outside regular clinical trials – and before the product reaches the market.
- Typical product is in phase II or phase III, targeting an indication for which there is no effective treatment
Increasingly widespread use of European EAPs means growing benefits
to drug developers including
- Invaluable ‘real life’ market experience
- The opportunity to book revenues through product sales
- Potential fillip for subsequent official launch
Bionest has developed a turn-key Pan-European EAP service including
Regulatory framework
- KOL mapping and discussions
- Full financial modeling and roll-out plan
- Implementation (including all billing and logistics)
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