June 27, 2021
Unlocking the power of clinical trial label management
VP of Life Sciences Product Management
The clinical trials industry has undergone immense change over the past decade as regulators have pushed for studies to be conducted across a wider geographic footprint and often for longer periods of time.
The focus on orphan diseases has also forced the industry to cast the net wider for eligible patients and meant that more countries are now involved in studies, each with their own sets of regulations and language requirements.
In addition, the growth of biologics over the past five years, which need careful storage and management, has increased the costs of trial supplies, making it vital for clinical trials organizers to minimize overage; while the rise in adaptive trials means that they must be fleet of foot and flexible.
In this blog, we will explore how Loftware has evolved its labeling solution to help customers tackle these challenges and complement traditional production supply models with more flexible on-demand or just-in-time (JIT) models.
As more countries are included in a clinical trial, creating a single booklet for 50 or more countries, each with its own regulatory requirements, and possibly multiple languages, can be a major undertaking.
To simplify the process, we have revolutionized the traditional approach to Master Label Text (MLT) and Country Label Text (CLT) definition with our Loftware PRISYM 360 platform. This means that users can input Investigational Medicinal Product (IMP) and protocol information, and then apply pre-defined regulatory rules and intelligence.
These features, combined with the ability to create a translation library for regularly used phrases to avoid repeat translation costs, mean that complex booklets that once took months to produce, can now be created automatically within hours. Furthermore, changes can easily be made to booklet designs once studies are underway.
Single panel labels
With the rise of on-demand or JIT models, some companies have now turned to single panel labels rather than complex booklets. Once a patient has confirmed that they will be attending a clinical trial site to receive their treatment, our software facilitates the on-demand printing of clinical labels, utilizing the latest expiry dates, for the clinical trial pack to be shipped to the site.
A key advantage of single labels over booklets is that they dramatically reduce the amount of information on a product and are, therefore, more patient-friendly. This, in turn, helps to support adherence which is, of course, essential, particularly given the difficulty in recruiting patients and the implications for study results if patients drop out.
To ensure that we continue to respond to customers’ changing needs, the Loftware PRISYM 360 platform is constantly evolving and new features are being regularly introduced. For example, we have recently increased the types of rules included in our regulatory rules and made it even easier to request translations for required phrases.
In response to the pandemic, we have also enabled customers to get a fully validated in-house labeling system up and running within weeks, following the launch of the cloud-based, ready-to-use version of our clinical trials labeling platform.
And we provide support on quality control with our Vision software, which checks to ensure the final printed output is the same as what was sent to the printer, identifying print errors in barcodes and label elements that may be unnoticeable to the human eye.
A competitive edge
As clinical supplies teams come under increased pressure to be patient-centric and fleet of foot, clinical trial label management is a key area where operations can be streamlined to enable clinical trial kits to be packed, labeled, and shipped to the site efficiently and compliantly.
Indeed, by enabling users to manage phrase translations and regulatory rules and make changes to labels in real-time at the touch of a button, our innovative software plays a crucial role in the switch to on-demand and JIT models – thereby helping to give our customers a competitive edge in the fast-changing clinical trials industry.
- Supply Chain