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October 26, 2022

Press Release

Loftware Prisym 360 Version 1.16 Strengthens ‘All-In-One’ Clinical Trials Labeling Solution with New Features to Deliver Efficiencies and Simplify Compliance

Release Incorporates Clinical Data Connector and Randomization Module to Support End-To-End Management of Streamlined Clinical Labeling Processes

Portsmouth, NH — 26 October 2022 – Loftware, the global leader in Enterprise Labeling and Artwork Management solutions, today announced the availability of Loftware Prisym 360 1.16. The latest release of Loftware’s cloud-based clinical trials label and content management solution adds two new features designed to increase the efficiency of clinical trial supplies operations while reducing risk and simplifying compliance.

Prisym 360 1.16 introduces a new Clinical Data Connector, which streamlines the end-to-end clinical labeling process by connecting clinical supplies applications to Prisym 360’s label and booklet design features. This removes the need for any label data to be input manually, helping to automate the process of GxP-compliant label printing and saving valuable user time while reducing the risks associated with manual inputs.

Supporting widely used industry protocols and standards, such as Web Services, SOAP, and REST, to maximize its compatibility with a customer’s existing clinical supplies management applications, the Clinical Data Connector allows for the creation and revision of clinical trial master label data within Prisym 360. Consequently, a customer’s existing clinical supplies application gains the ability to send print requests and associated data to Prisym 360 to produce labels on demand.

Additionally, Prisym 360 1.16 introduces a Randomization Module, which provides a comprehensive set of clinical label randomization functions that are fully integrated and available through a simple and intuitive user interface. Providing randomization functionality, especially valuable to organizations or teams without access to a RTSM application, the module has been designed in close collaboration with clinical supplies teams within several leading pharmaceutical R&D organizations and clinical supplies service providers. Through a step-by-step process, users can create randomization definitions to generate data for clinical trials packs while remaining fully integrated and compatible with Prisym 360’s other clinical trials labeling functions, including the Clinical Data Connector and the 3-Step Clinical Label Print Process.

Both new features have been developed with direct input from existing users and are designed to support industry best practice. Due to the modular nature of Prisym 360, customers can flexibly upgrade their solution to access this new functionality if desired.

Simon Jones, Loftware VP Product Management, Life Sciences, said: “The pressure to reduce trial start-up times coupled with the growth in adaptive clinical trials has prompted focus amongst clinical supplies software application vendors to help streamline the end-to-end clinical trial supplies process. The Prisym 360 Clinical Data Connector, developed with input from best-of-breed Clinical Supplies Management vendors, such as Signant Health, helps simplify inter-connection with Prisym 360, thereby removing the need for manual data entry.

“Similarly, the new Randomization Module is designed to simplify the process of performing patient and kit-based randomization, as being integral within Prisym 360 aids with ease of use whilst helping customers ensure GxP compliance.”

The Prisym 360 Clinical Data Connector and Data Randomization modules are now available as part of the latest 1.16 product release of Prisym 360. For more information, visit www.loftware.com

 

About Loftware

Loftware is the world’s largest cloud-based Enterprise Labeling and Artwork Management provider, offering an end-to-end labeling solution platform for companies of all sizes. Maintaining a global presence with offices in the US, UK, Germany, Slovenia, China, and Singapore, Loftware boasts over 35 years of expertise in solving labeling challenges. We help companies improve accuracy, traceability and compliance while improving the quality, speed, and efficiency of their labeling. As the leading global provider of Enterprise Labeling and Artwork Management, along with Clinical Trials Labeling and Content Management, Loftware enables supply chain agility, supports evolving regulations, and optimizes business operations for a wide range of industries. These include automotive, chemicals, consumer products, electronics, food & beverage, manufacturing, medical device, pharmaceuticals, retail and apparel.

  • Cloud
  • Regulatory
  • Clinical Trials