Clinical Trial Randomization, Supplies and RTSM Systems, Part 2

January 14, 2020

[vc_row][vc_column][vc_column_text]In part one of this multi-part blog series, we went over some of the basic qualities and roles played by RTSM systems in clinical trials. Short for Randomization and Trial Supply Management, RTSM systems are vital for both randomization in trials and various tracking and management areas that clinical researchers benefit from in numerous ways.

At AGA Clinical Trials, we’re happy to explain the use of RTSM and related systems for any of our clinical research studies. In today’s part two, we’ll dig into several additional qualities of RTSM systems within the medical research field, plus why these are often the perfect fit for a given study in multiple areas.

History Audit

In addition to site activation and reordering needs, which we went over in part one here, RTSM systems are also highly valuable for the kinds of product history information they can provide to researchers. Clinical research is an area that requires a great deal of detailed record-keeping to help keep certain drugs or treatments categorized properly, and RTSM systems allow researchers to go over the full history of any drug – all the way from when the order was placed to when it is assigned to a given patient.

In other cases, researchers can use the RTSM system to hone in on a single patient within their study, viewing their entire record within the study. Finally, in cases where sites need to decline items for any reason, RTSM systems can track this and give important information to administrators. If a single site has a high frequency of items arriving damaged and being returned, for instance, RTSM supply histories will show this trend and allow for adjustments.

Site Assignments

Now, within the product realm for clinical trials, multiple distributors are often used by a given research site. It’s vital for sites to have the processes in place to deal with such varied sources of distribution, and RTSM systems are valuable here as well.

These systems contain both manual and automated functions that are both utilized by researchers. Manual override functions are necessary for moving products between research sites based on overstocking or disposal needs, but automated ones maintain communication with distributors that would be difficult to keep up with manually.

Site Assignments

In many research studies, certain factors are involved in the decision on which patients are assigned a given product. One primary example is gender, which often determines the quantity of a given product that’s received – weight may also play a role.

In these cases, RTSM systems are very important. They allow user-defined formulas to be inputted by researchers, meaning study organizers can input their own factors in advance to help determine their required quantities from a distributor.

For more on the value of RTSM systems in clinical trials, or to learn about any of our clinical trials, speak to the staff at AGA Clinical Trials today.

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