Randomization and Trial Supply Management: 5 features to look for

Randomization and Trial Supply Management (RTSM) technology is one of the driving forces behind every clinical trial. However, because it’s such a behind-the-scenes technology, many clinical trial managers may not be up-to-date on its latest advances — or about changes on the horizon.

RTSM refers to the tools site administrators use to enroll and randomize patients, as well as manage trial drug supplies. It’s an umbrella term that includes Interactive Voice Response Systems (IVRS) and the more modern Interactive Web Response Systems (IWRS). It's also common for both of these technologies referred to as Interactive Response Technology (IRT) as both function in a similar way: Both are tools for a trial coordinator to enter information about a patient’s basic demographics and their visit. Then, the system randomizes that patient and gives the patient a trial drug assignment. The whole process is blinded — the study coordinator doesn’t see which patients are assigned to which arms of a given study.

Recently, RTSM companies have introduced new features to help trials get off the ground faster and run smoothly throughout the entire process. Be on the lookout for these interesting features as companies continue to compete for business in the clinical trial management space.

Track the temperature of your drug supplies on your phone.

In November, the CRO and RTSM vendor Parexel announced a new feature on its mobile app: the ability to track the temperature of study drug supply throughout the shipping process via Bluetooth sensors. It’s a small detail, but if certain drugs aren’t kept at the right temperature, it can seriously delay a trial. 

Use Natural Language Processing to set up your RTSM.

Speed and flexibility are two of the most important features to look at when evaluating an RTSM system. This year, the company 4G Clinical set itself apart by introducing a natural language processing feature in its RTSM. The system works by reading and interpreting written specifications and then building the system from there. The company says using their technology, they can set up a new system in less than two weeks. They also say it’s easy to make adjustments by changing the system’s written directions, giving you flexibility throughout your study.

Pool your study drugs if you’re managing multiple trials.

If running multiple arms of the same trial are running out of a study site, a new feature from the RTSM vendor Medidata could make a real difference for trials. The functionality allows sites to set up drug pooling in-house, without contacting the RTSM company. Medidata says this feature can cut supply costs by one-third, in addition to saving time.

Use agile RTSM to set up your trial faster.

Several vendors leverage this approach to reduce the set-up time for RTSM. Traditionally, an RTSM vendor would design the whole system before users had the chance to test it out. In agile systems, an initial set-up is created based on the protocol before approvals, allowing for system testing and making changes before user acceptance testing.

Better connect all of your clinical trial technology systems.

Even if individual technologies work well on their own, they’re not helpful if they can’t communicate with each other. Recently, Bracket, a company that provides RTSM as well as other clinical trial technologies, acquired the electronic patient-reported outcomes (ePRO) company mProve. Now, Bracket’s electronic clinical outcome assessment (eCOA) technology and its RTSM can easily communicate with each other and patient-reported outcomes can be seamlessly incorporated as well.

At Antidote, we use technology to connect engaged patients with the latest research. Learn how we can help boost recruitment for your next trial.