Randomization and Trial Supply Management Clinical StudioWhile it’s yet another term on a long list of clinical research acronyms, RTSM has become a valuable asset in the eClinical technology toolkit. RTSM stands for Randomization and Trial Supply Management and serves two main purposes. First, randomization helps eliminate the occurrence of bias in deciding which patients are assigned to which treatment groups in a trial. Second, trial supply management ensures products for a clinical trial are accurately and efficiently tracked and managed from the distributor to the site, to assigning and finally distributing the product to patients.

Several years back, randomization was disparate from supply management until it was discovered that they work better together in unison. Since then, RTSM has experienced an evolution and become the platform we know it as today: an important supplement to electronic data capture (EDC) systems or clinical trial management systems (CTMS). It’s also commonly known as IWRS, which stands for Interactive Web Response System, or Interactive Response Technology (IRT). So, what makes a RTSM platform the right fit for your organization? Here, we examine eight capabilities your system of choice should include and why they are important.

1. Site activation

For regulatory purposes, sites in a study are activated individually as they get approved to receive drug, or trial supply. When a RTSM system activates sites, it should notify both the distributor and the site specifying which items to expect, along with all pertinent details of each item. Lot, item number, and expiration dates may be a few examples.

The system then picks inventory items based on predefined parameters of the site level ceiling to allocate out to the site. Next, the system tells the distributor to ship the allotted items to the site. The site can then log into the RTSM system and log that they received the items physically. By “accepting” the items they received, those items become available to use with patients. This is one area where an RTSM integrated with the same database as the study data becomes valuable. It alleviates site users from needing to log information in two different systems.

2. Automatic reordering

Eventually, the supply will become depleted at a site. When this happens, a RTSM system must be able to submit a reorder once it hits the floor level – a predefined minimum quantity of inventory to maintain. To return the inventory to its predefined ceiling level, the system will see what’s available at a distribution center and place an order accordingly.

Much of the system process is driven by automated notifications to the distributor who ships the product to sites. Given that distributors maintain their own inventory systems, it’s important that a system keeps an ongoing log of emails that have been sent and who they were sent to. This provides administrative oversight on history of what automation is occurring.

3. Predictive reordering

This functionality adds a layer of complexity to automatic reordering; predictive reordering is a more proactive approach to supply chain optimization. Simply following a static floor level and ceiling level is sometimes not enough. A system should have predictive capabilities in order to avoid depleted site inventories when product is needed faster than the supply chain can produce orders.

As a simple example, if the floor level at a site is 3 of a given product, the system will recognize when there are 5 of that product remaining in the supply. This way, the system can send an order to a distributor, taking into account lead time and delivery time so inventory will never be less than 3 items.  

4. Product history audit

RTSM systems should also provide the user with a thorough product history. For instance, users can easily generate a comprehensive breakdown of each drug’s full history from the order being placed with the distributor to being assigned to a patient. Or, users can filter out a specific patient and look at the entire history of that patient’s record. Site rejection of inventory is also a key factor.

When sites decline items for any reason (e.g. shipment not received, item damaged, overstock, etc.), it may be important for an administrator to understand trends in product supply issues. For example, if one site has a high frequency of damaged items, this can easily be seen in the supply history.

5. Multiple distributors and site assignments

Investigational products don’t always come from a single distributor. Flexibility is needed to set up multiple global distributors and assign specific study sites to each one. Administrative approval is needed to maintain regulatory controls on which distributors are able to ship products. Considering many distributors would not directly be logging in to a study specific RTSM platform, continual automated communications from the system with the distributor is very necessary. Just the same, manual override functions are needed to move products between sites due to overstock or back to the distributor for proper disposal when applicable.

6. Algorithm-based subject assignments

Oftentimes, a number of factors influence how a patient is assigned products in a clinical trial. For example, a patient’s gender and weight may determine quantity of product received by that specific subject. The system cannot simply assign an item from inventory. Instead, it needs to assign different quantities from the site’s inventory on a per subject basis. That’s why it’s important for RTSM software to allow for user-defined formulas which include data points from the subjects’ records as factors to determine specific needed quantities. Predictive reordering discussed above relies heavily on this as well.

7. Status reports

The automated generation of status reports is another important function of a RTSM system. Some useful reports may include: how much inventory a site has at any given time, an audit history on a per item basis, or an audit history of all emails sent by the system. Reports that are readily accessible and easy to read will help users identify action items and optimize supply. These should provide a whole study overview of product distribution and trends for sponsors to manually move products around proactively if needed. Notifications can also be set for user-defined events. For example, if a site reports more than three missing items in shipment.

8. Configurability for different scenarios

Keep the right people up-to-date throughout the life of the trial with customized, automated notifications. Additionally, the ability to copy key users on email is crucial; for example, including the distributor in emails because they can’t ship products without this notice.

Also worth considering is the ability to flexibly define a custom workflow and setting up notices on each workflow level. Different studies may require different processes for the life cycles of inventory items. It’s important to have a platform that allows for these types of definitions.

Bonus feature: EDC/CTMS integration

TrialKit offers RTSM (or, IWRS) out-of-the-box and fully integrated with the rest of the EDC system for a truly seamless trial management experience. In TrialKit, sites only need to log in one place to manage study data, randomization, and IP supply to see increased efficiencies. Allocating subjects and managing inventory can be accomplished from a mobile device at both the site level and at the administrative study level. TrialKit leverages built-in error checks to increase accuracy and eliminate human error from the process.

RTSM may also be utilized on a desktop via Clinical Studio, TrialKit’s web companion. Contact us today to have one of our product experts answer your questions on randomization and trial supply management optimization.