Operationalize the IP distribution for Decentralized/Hybrid Decentralized Trials

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July 14, 2020

Operationalize the IP distribution for Decentralized/Hybrid Decentralized Trials

My company is working on the ability to operationalize IP distribution for decentralized/hybrid decentralized trials. We looking for benchmarking that could help with flexibility in protocol language that provides flexibility in specifically providing IP.

If you have examples of Decentralized /Hybrid Decentralized Trials:
• Does the protocol template always call out dispensing?
o Does it have to?
• Do you have any examples/suggestion on how much IP particulars (where, how, when, quantities, etc…) needs to be a protocol with regards to IP?
• For this type of trial would you use a multiple visit dispensing approach?
• Do you handle dispensing for home nursing and dispensing for onsite visits differently in these types of trials?

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