Within a variety of clinical studies, particularly those utilizing single-blind or double-blind formats, one area that’s often very important is randomization. Over recent years, most clinical research facilities have adopted detailed systems to help with this area, broadly classified as RTSM systems – short for Randomization and Trial Supply Management.
At AGA Clinical Trials, we’re happy to explain how randomization works and why it’s so important for many of our medical research studies. This multi-part blog will dig into exactly what RTSM systems are and why they’ve become so widely-used, plus the numerous elements they can help both researchers and trial participants with throughout the process.
Primary Purposes of RTSM Systems
There are two main purposes that brought about RTSM systems and have driven their popularity over recent years:
- Randomization is vital for eliminating bias while deciding which patients are assigned to specific treatment groups for a trial, and RTSM systems perform important functions in this area.
- Products for a clinical trial must be not only properly disbursed, but also accurately tracked and managed all the way from the distributor to the site, and then to patients. RTSM systems also infuse this kind of thing into the same single platform, supplementing data capture based on the results of the trial.
The remainder of our series will focus on some of the numerous capabilities carried by RTSM systems, depending on the facility they’re being used in and the kinds of studies being performed.
When it comes to regulatory areas, research study sites are activated individually as they become approved to receive a given drug or trial supply. RTSM systems are regularly used to activate sites, notifying both the distributor and the site on which items will be sent and the details involved in each of them – things like lot, item number and expiration date, among others.
From here, the system proceeds to pick inventory items based on preset parameters for the site. It directs distributors to ship the proper items to the site. Next, researchers at the site can log into the RTSM system and confirm they’ve received the items once they arrive, at which point these products are available for use with patients.
In addition, RTSM systems are hugely valuable for reordering areas when a given site runs low on supplies. They handle two primary areas here:
- Automatic reordering: The system can detect when supply levels are becoming low, check what’s available at distribution centers, and place orders based on this information. It can also send automated notifications to distributors to maintain administrative oversight.
- Predictive reordering: In other cases, RTSM systems can be set up to take a proactive approach to reordering. The system can be tailored to automatically recognize shortages in advance, accounting for lead and delivery time so inventory does not sit below required levels for even a single day.
For more on the value of RTSM systems within clinical trials, or to learn about any of our study options, speak to the staff at AGA Clinical Trials today.