The Extreme Bare Essentials Needed To Open Your Own Clinical Research Site

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Today’s question comes from someone who wants to open a research clinic. They’re a doctor, and they have a lot of patients in their private practice. They became interested in clinical research because they were added on as a sub-investigator for a trial and since then they became intrigued with research. They started talking to the PI about it, and the PI let them know that it is really lucrative — which it can be if it’s run and managed the right way. So this doctor wants to start his own clinic, and he’s asking me what the bare minimum requirements and time commitments are for having a regular, basic clinic. So when I talk about having a regular, basic clinic, I’m talking about having enough space, staff, and capabilities to conduct in your first year anywhere from 5–10 clinical trials. You can always grow after that point and open up another clinic or maybe expand your existing clinic if space permits. You could also move; I know a lot of clinics that started off really small and then they moved to bigger facilities as they grew. I’ve also seen sites that started off small and then because they got more demand and more studies but could not physically move their site, they opened up another clinic somewhere else in their city where they would conduct certain types of clinical trials. They would run 2 sites with 2 different PIs. There are a lot of different ways to do this. To meet the bare minimum requirements, you will need an office with at least 3 rooms that can be dedicated to just research. Chances are you already have an exam room, which you can share between your research clinic and your private practice. However, if you happen to have a very busy private practice then you might want to have a second exam room. Of the 3 other rooms that you need, you are most likely already using one of the three as the PI so you really only need 2 other rooms. You really need a room for the coordinators and a room for the monitors when they come in. You probably don’t want to have the monitors share a room with the study coordinators because then they can go looking at things laying out on the desk. Most coordinators will clean up at the end of the day, but during the day — especially at a busy clinic — it could be messy and you don’t want a CRA seeing that along with other protocols because then they will assume that other CRAs are seeing their protocol and the sponsor could make an issue of this. So have a separate room for monitors and a separate room for coordinators. You’re going to need a place to store your IP, but I didn’t include an IP room as an additional room you need to have because at the bare minimum you could have an IP cabinet that would be double locked and temperature controlled in either the study coordinator room or in your room as the PI. The best thing to do would be to have a separate room dedicated to just IP and have limited access to it. One of the issues with having the IP cabinet in the coordinator room or the PI room is if patients are going there, the sponsor or FDA will ask in an audit how you are preventing patients from going into the IP cabinet when you are not in the room. So having a separate IP room that has zero foot traffic going through it except for people who belong there would be ideal but not mandatory. You will need a centrifuge and a refrigerator for IP and specimen that need to be kept refrigerated. You will also need a fax machine and internet. ECG machines are usually provided by the sponsor, but increasingly I see that they are starting to request that sites have their own. And that’s about it. People usually underestimate the amount of physical space that one protocol can take up as far as all the source documents and regulatory documents go. So you need to be careful not to underestimate how much space you will need. You’ll also need a waiver to let you process and draw blood and you’ll need a lab room where you can process the labs and ship them out. As far as time commitments go, if you as the PI delegate properly to coordinators, you don’t need that much time. You can dedicate about 50% of your time to doing clinical stuff and 50% percent for your private practice. You can probably push that to 80% for your private practice and 20% for clinical research. There will be a lot of overlap especially since you are in the same office where the research is being conducted. So if the monitor is there and you’re there at your private practice you can see them. So for the bare minimum, that’s what you’ll need to get started.

Dan Sferabusiness, research clinic, pi, sub i, si, study coordinator, start up, own a site, equipment4 Comments