Many brand new research sites are struggling to find Principal Investigators for their various clinical trials. In this video I share a few ideas on what and how to present to a potential PI once you have identified a few potential candidates.
In the quest of launching my own Contract Research Organization this year, I have stumbled across several strategies for bootstrapping your own CRO. Mind you however, my team has been laying the foundation for this CRO for the past decade so while we are only now offering our full CRO services, we have been gathering our resources for quite some time. While the infrastructure we have laid out may not be practical for a brand new startup, many of these bootstrapping activities and strategies might.
It's actually not that difficult. If you have a brand new clinical research site, finding an experienced clinical research study coordinator is probably your best option. This is especially the case if you, the site owner, does not have any experience. Often times, experienced study coordinators may feel under appreciated at their current place of employment, or perhaps it is a clinic that rewards their good work with more work. Whatever the case may be, you can usually find a good study coordinator without much effort. In this video I describe some strategies.
Clinical trials can get quite complex and many research clinics have started noticing even more complicated protocols as the number of total research sites continues to increase every year. It is no wonder that many site directors and study coordinators may get intimidated when confronted with a particular assessment, or perhaps a piece of equipment that the Sponsor requires the site to have. Fortunately, everything and anything can be outsourced by the site to specialists who routinely conduct said assessments. As a general rule, I never tell a Sponsor that I cannot do something. If I am unsure of what they are even referring to, I still reply with "I will find out for you". Hope this helps!
So many of you want to get started in the clinical research industry but have no clue how. In this video I give some advice for those individuals in this situation. Let me know if any strategies have worked for you in the past. Here is an article I wrote recently about how you can get started in this line of work without any prior experience. Hope it helps.
Many new research site owners are relieved when they learn that they have just been accepted to participate in their first clinical trial. This is a natural feeling, however, there is little time to relax. This is where the real work begins. In this video I explain what happens next so you can get a better idea of what you can expect.
On this blog, I try to give practical advice to anyone who may be interested in learning more about the clinical research industry. While a lot of attention has been given to the research sites, CRA's, and the like, not very much has been said about project managers. In this video I discuss some common interview questions that a CRO or a pharmaceutical company might ask of any potential project manager candidate. Hope this can help some of you out!
One of the most important yet least discussed topic in clinical research: the process of consent.
In the clinical research industry, it is quite easy to get lost in the details of what we are actually doing. For new entrants into the field, I have already created a 2 hour crash course of what clinical research entails, however I realize many of you are still having a hard time understanding the bigger picture in this line of work. In this interview I conducted with a brand new student who has enrolled in my CRA Academy, I answer some of his questions and give him a general overview of the entire clinical research industry including many of the key moving parts. I hope this will be able to help many others out there!
One of the most frequent questions I receive from my startup clinical research clients involve Investigator Meetings. What occurs at these Investigator Meetings? Are they mandatory to attend? Who typically goes?, etc. Hope this video can help some others out there who are asking these same questions.
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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.
Here are links to the basic equipment/supplies you will need:
One of the seemingly most popular subject matters that I have covered on this blog has been contract and budget negotiations when it comes to clinical research sites, contract research organizations, and pharmaceutical sponsors. The better each site gets at negotiating contracts and budgets actually bodes well for the rest of the industry in general. Hope this video can help you out with a few strategies.
For those of us who work in the clinical research industry, we are sometimes unaware of the fact that Sponsors spend even more money on advertising and selling their drugs than they do on research and development to produce them. It is very easy for us researchers to get lost in our own little (big) segment of the industry to pay much attention to the sales aspect. In this video, Darshan Kulkarni joins the Guru Nation to discuss advertising and sales regulations when it comes to drug manufacturers, and what us researchers may be interested in learning more about. I hope this interview is able to provide some value for you!
Business development is essentially a fancy way of calling it when one business needs to convince another business to work with them. Clinical research is primarily a business to business endeavor on the backend (when sites or CRO's pitch Sponsors for the right to conduct a study), and a business to consumer endeavor on the front end (sites and CRO's recruiting study participants to enroll in the studies). In this video, my business partner and I discuss the various ways we have been successful in bringing new studies to our clinics and our clients. Would love to hear some of your strategies as well Guru Nation!
I have owned and operated numerous clinical research sites since roughly 2005. To me it has been quite a learning process as I have hired, trained, retained, fired, partnered with and promoted clinical research study coordinators. In this video I do my best to give a summary of what traits I think you should look for in your next study coordinator. Leave your comments below please!
I have received many questions in the past from viewers, partners and even clients in regards to what a research clinic needs to have in place for a site selection visit. These are the bare minimum requirements but I hope this video will be helpful to some of you who are anxious about your first site selection visits.
There is not too much to explain in this text, the video and image pretty much sum it up. There are way too many acronyms in clinical research and there is no wonder why there is so much confusion. Needless to say, it could become quite overwhelming for new entrants in the industry.
The vast opportunities that exist within the clinical research industry are rarely discussed outside of people who are already working in this field. When you take a look at just a research site, let alone a CRO or a pharmaceutical sponsor, one can begin to see the seemingly limitless possibilities that are available. In this video I decided to delve deeper into this topic in hopes of shining some much needed light in this direction.
So you've just been assigned to a new clinical research protocol and haven't had a chance to familiarize yourself with all the finer details; what's a study coordinator or cra to do? No worries, your best friend will be the schedule of assessments. If you simply follow the schedule of assessments you will at least understand what procedures (and sometimes even their order) that need to occur at every visit. This by no means makes you an expert on the particular study, but you will at least know the basics. There is never a substitute for a deep understanding of any clinical research protocol.
It is no mystery that patient recruitment is the single biggest barrier to the success of most clinical trials. One possible method for improving recruitment at the research site level is perhaps door knocking other medical practices and physician offices in order to get patient referrals from them. As most things go, this is far easier said than done, and it is my personal belief that most sites simply do not do enough if any door knocking of their own for a multitude of reasons that would probably make for an excellent follow up blog post.