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Why short people gotta take the exit row ?
Unless they are a consultant
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I’ve been in the industry for over 10 years. I’m not sure what or why starting an IRB would accomplish. Most industry studies will already have a central IRB over seeing the study and as a site you would be submitted to that IRB for approval. I agree that clinical trials.gov is a good place to find trials that are in various stages of progress. You can reach out to sponsors/drug companies to let them know you are interested in participating in clinical trials. You will need to complete some vetting processes such as feasibility that shows your site is capable of conducting clinical trials…ie have coordinators, phlebotomists space to conduct study visits, a CV documenting experience in the specific therapeutic area the study is researching. You will also need to show you have access to the specific study population and can recruit subjects. You will need someone to negotiate your contract. This is just a few suggestions. But an IRB is not what I would suggest you focus on.
It truly depends on who will be in charge/responsible for the research - will it be his venture alone or will the hospital be involved in contracts with their lawyers?
Then he should invest in a qualified CRC - preferably someone who has been a site manager in a hospital setting.
I would start with does the hospital want to create an IRB (internal review board) and do they have the ability to do that. I don't know what it takes to create one, but I would start research at first.
I know for my site, you have to have the IRB to approve the protocols for the site or provide what changes need to be made in order for your site to be able to accomplish the study.
Please reply, so we can communicate more easily.
gmantell@ptd.net
I have a friend who has a business helping physicians start their Clinical Research. They're a site network. They get doctors with no experience who are interested in clinical research involved by setting up their practice as research sites. She can be reached at nndukwe@myicrc.com.
Would an IRB be beneficial with no active clinical trials at the site? Or would it be more cost effective to outsource the IRB initially?
I recommend looking at the HHS.gov website. They have great information regarding examination of clinical trial costs and barriers. Also great source is Advarra.com. They have information on the advantages of outsourcing IRB’s. Another great source is FDA.gov they have IRB FAQ’s. Hope this helps!