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Guest
#11 · June 15, 2022, 2:00 pm
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I would still recommend not using veeva or any other solutions that require the sponsor to pay to access the information. Then you end up with an eISF that needs printing. The pricing could be up to 25k development costs. 

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brad@brad
184 Posts
#12 · June 15, 2022, 3:37 pm
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Quote from Guest on June 15, 2022, 2:00 pm

I would still recommend not using veeva or any other solutions that require the sponsor to pay to access the information. Then you end up with an eISF that needs printing. The pricing could be up to 25k development costs. 

Is this a realistic possibility? Can the site not grant access to the CRA without the CRO paying?

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Jeanette@site-line
25 Posts
#13 · June 15, 2022, 11:50 pm
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Quote from brad on June 15, 2022, 3:37 pm
Quote from Guest on June 15, 2022, 2:00 pm

I would still recommend not using veeva or any other solutions that require the sponsor to pay to access the information. Then you end up with an eISF that needs printing. The pricing could be up to 25k development costs. 

Is this a realistic possibility? Can the site not grant access to the CRA without the CRO paying?

Our site uses Veeva Site Vault for Regulatory and we provide the CRA access to all regulatory documents. They are not charged to access any documents, and none of these are ever printed. (If the CRA chooses the print any documents, it is only after they already have access to the system, and I don't see a reason why that would ever be done). We do not own Veeva, so it would actually be impossible to charge someone to access a system we do not own ourselves.

Remote monitoring fees could be invoiced if negotiated in the budget, but that is not specific to Veeva. 

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