The era of big data in clinical research is upon us. In this video i discuss ways that Sponsors are CRO's are tracking clinical trial sites and what the most important metrics are in my personal opinion. Bottom line: everything is being tracked and matters!
Ever wondered what a clinical research protocol synopsis actually consists of. In this long video we break down a typical protocol synopsis and discuss some of the key elements that most share.
It is no secret that the clinical research industry is unbridled with turnover, particularly amongst the clinical research associates. In this video I discuss strategies that executives at CRO's can implement to lower this metric.
There are so many opportunities in the clinical research industry. At the site level, some are study coordinator, principal investigator, sub investigator, research assistant. At the CRO level there are CRA's, CTA's, CMA's, medical monitors, project managers. At Sponsor level there are dozens of others. What is good about many of these, is one's ability to "level up" over time into more desireable and higher paying positions.
In late 2016, the FDA revised the ICH GCP guidelines. You can read all about it on my news blog here. In this video I give my personal commentary on how I think this will affect Clinical Research associates and Contract Research Organizations.
Ever wondered how Contract Research Organizations select which Clinical Research Associates will be put on which clinical trial? In this video I try to demystify this CRA staffing topic and discuss how the Sponsor can also tend to influence things.
Sometimes as a clinical research site owner (or perhaps even as a CRO or a Sponsor), you will come across a scenario where you will need to partner with a specialist for a rare disease or indication. In this video I make some suggestions for how to go about doing this. My CRO has already begun to implement some of these strategies.
There is a lot of waste in the clinical research industry. I am not just talking about wasted money, I am also talking about wasting other people's time and efforts. In this interview with Luke Edington from DataPharm (Australia's oldest CRO), I discuss ways in which Contract Research Organizations such as my own can help improve efficiency in this industry. I hope you enjoy!
In my process of launching my own CRO startup, I have broken down what a CRO typically does into tiny manageable chunks that we can look into and learn from. New business models are created when inefficiencies are discovered in the previous ones. In fact, the inefficiencies of the drugmakers during the clinical trial process is precisely what paved the way for modern day CRO's. These days, the riches are in the niches as new inefficiencies emerge due to new technologies.
In this video, I interviewed Luke Edington of DataPharm , Australia's oldest CRO. We discussed DIA 2016 conference which occurred in June 2016 and covered all of the trends and hot topics in the clinical research industry these days.
In this video, Chris Sauber and I discuss in depth strategies for how to expand your principal investigator network for your clinical research company.
Site Management Organizations (SMO's) evolved over the past several decades from small research sites to nationwide research networks. Unfortunately many developed bad reputations and Sponsors as well as CRO's have shied away from using the, This video explains why, and I also get into some other topics such as how to obtain studies for your company and more. Enjoy!
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.
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!
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!
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!
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!
Maintaining a high level of professionalism can improve your odds of obtaining future studies with sponsors. Sponsors will also appreciate and respond well to the enrollment power of your site.