Medical device trial budget - 2 hospitals for Class IIa medical device in Sweden

#1
If a sponsor wants to conduct a Clinical trial at 2 hospitals for Class IIa medical device in Sweden, then, how much will be the cost?
 
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yodon

Staff member
Super Moderator
#2
Well, seeing that nobody has yet to reply, maybe this will get the ball rolling a bit.

Caveats: I have never been associated with a device trial in Sweden so things may be different.

In the US, costs vary wildly. Factors include how many study subjects, how long the trial goes, arrangements with doctors, if you have to pay subjects, etc. I've mostly been associated with trials managed by a CRO and so there's yet another cost. I've seen trials ranging from tens of thousands to hundreds of thousands to millions. I've always engaged with a CROs to get cost estimates.
 

Watchcat

Trusted Information Resource
#3
As an MBA, I will tell you that how much something "costs" depends on how much you pay for it. If you pay $1 million, that's what it cost you. If someone else can buy the same thing for $10,000, that's what it cost them.

There are many factors that influence the cost of a trial. Yodon has listed some of them.

You can find a "full service" CRO that will take care of everything from regulatory authorizations to study design, protocol/consent/CRF development, to budget negotiations with the investigators, to monitoring, to managing study supplies, to data management, to final report. They typically work on a basis of 1/3 cost, 1/3 overhead, 1/3 profit, so anything you can competently handle yourself can reduce your costs a good bit. CROs are usually willing to give cost estimates, but the reliability of their estimate depends on the information you are able to provide them. You will get the best estimate if you have a trial protocol available for them to base their estimate on.
 
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