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!
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.
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.
This is some very simple but practical advice for my research sites out there: do not put your contract and budgets in the regulatory binder. Instead provide a note to file that explains where these documents will be kept.
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!
I was fortunate enough to have one of the industry's most innovative CEO's, Ibs Mahmood from Drug Dev come on the show and share his insights in regards to what is happening in the clinical research industry. We especially dive into issues such as clinical trial site payments, how risk based monitoring is affecting research clinics, and also how big data is allowing for transparent and clear site metrics to be tracked and shared by and amongst sponsors and CRO's.