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.
I have done many videos of this sort in the past but have usually focused on strategies for paying Principal Investigators. In this particular video, I discuss some creative ways to reimburse your sub investigators that you end up inevitably working with at your clinical trial sites. What are some of the ways you have compensated sub investigators?
It is natural for companies to want to expand. I believe that we as entrepreneurs are always looking for ways to increase our market share. Unfortunately, too many research clinics try to grow too big too quickly, and we end up with failed companies. I have countless viewers that email me that they would like to launch their own Site Management Organization (SMO). Not only do SMO's have bad reputations, it is my personal opinion that you should start off with one clinic and only expand when you have to, or when the market dictates. In this video I answer a viewer question in regards to their site expanding out of necessity-they simply ran out of real estate in their existing office. I go through some of the challenges, and explain how to perhaps make the process a bit easier. Let me know your thoughts.
While I have never been nor do I have any plans on being a CRA, I do work with many CRA's on a regular basis, most notably with the CRA's who teach my CRA Academy every week. I know that one of the questions that often come up during CRA job interviews is in regards to monitoring plans and what they are. In this video I try to explain the topic and share some of my knowledge to the best of my ability. Feel free to chime in with your experiences in the comments section below.
It is no surprise with CRA salaries being at an all time high (starting at 80k???), that the interview process is quite thorough. Fear not my future CRA friends, I am here to help. Since I launched my CRA Academy earlier this year in 2016, we have helped quite a few students get through the interview process once they finished our program and gained the required hands on experience. In this video I discuss what some trap questions are that recruiters, CRO's and Sponsors will ask Clinical Research Associates during their job interviews. In any case, I figured this video would be of help to some. Good luck on your future job interviews!
In this video, I give a bird's eye macro view on the entire clinical trial process from the perspective of a clinical research site. I have noticed that I often get into topics with such great detail that the bigger picture is often difficult to observe. This video attempts to do just that, zoom all the way out so we can all have a better understanding and context that can make studying the nuances of this industry that much easier.
Many people often confuse or use the acronyms IND and NDA interchangeably. In this video I explain the differences in meaning between an IND and an NDA in clinical research.
This post is for the physicians out there that are considering whether they should run clinical trials of their own. In this video I suggest three options that I have seen work well for others in the past. There are, of course, many other possibilities that could and probably have worked for many others, these are simply the three that I have seen most frequently.
Sponsors can end a study at any time. Sponsors working with Contract Research Organizations(CRO's) may also deactivate a site before final negotiations are complete.
New sites may have to wait at least six months before income occurs. This is because some sponsors may take long to decide which sites should receive a new study.
A close out visit can be considered a good thing or a bad thing. If your site is being scheduled before the study is over, it may be for poor performance.
A Site Management Organization (SMO) is basically a network of several sites. SMO's have recently developed a bad reputation with sponsors and Contract Research Organizations (CRO's).
One alternative to communicating with a confrontational Clinical Research Associate (CRA) is to seek the help of your assigned Institutional Review Board. Unfortunately, CRA's vary and some may not be as approachable as others.
If you decide to take on a study that you are not confident that you can complete, be aware of the differences between sponsor size, the performance of other sites, and protocol requirements. Challenging yourself beyond the capabilities of your site may leave a bad performance record.
Various trainings are often revered are important in clinical research. However, Principal Investigator (PI) oversight and staff experience are often erroneously overlooked as being important.
The research industry is heading towards an electronic era. Things such as Principal Investigator (PI) e- signatures for safety reports are becoming more common.