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Orphan Drug Trial Sponsors ‘Playing Catch-Up’ With Regulators – But Automation Can Help

 
• By Eliza Slawther

Clinical trial sponsors in the rare disease space face “big safety demands” from regulators, which can be challenging for those with limited resources. A CRO founder makes the case for “embedding automation” into the clinical trial process to keep pace with regulatory requirements.

Automation can help trial sponsors to meet safety demands, an expert says (Shutterstock)
Key Takeaways
  • Clinical trial sponsors in the rare disease sector face significant safety demands from regulators, but automation and AI can help them to improve their processes, the founder of CRO PharSafer, Graeme Ladds, says.

Developers of orphan medicines should embed automation into their clinical trial designs early to increase their chances of regulatory success,...

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