Loftware Prisym 360 for Clinical Trials

Loftware’s Prisym 360 is an innovative label and content management solution that incorporates industry best practice and is designed specifically to meet the complex regulatory requirements essential for clinical trial labeling.

Spectrum is the only all-in-one labeling solution to be delivered completely via a browser-based interface. It redefines how enterprises create, manage and print labels, enabling you to seamlessly implement, deploy, maintain and scale your labeling operations across your entire global network. Spectrum is built for the cloud. It includes everything you need to manage global labeling, from label design and print to lifecycle management. Loftware Spectrum for Medical Devices is specifically designed to help medical device manufacturers create and maintain a compliant labeling process. You can also use our Validation Accelerator Pack (VAP) to speed up the validation process.

Loftware NiceLabel offers everything you need to manage your labeling process, in one, easy-to-use system. Designed for rapid deployments at one site or across multiple locations. Loftware NiceLabel Cloud can be up and running in minutes while having everything you need to manage your entire labeling process, from label design and template management to printing. You can start small or local, and easily expand the system to multiple locations. Loftware NiceLabel Label Management System (LMS) on-premise installation, you can customize the LMS to your specific business needs and IT environment, and you have a clear path to the cloud when you’re ready to make the change.

The information that accompanies clinical trial products is essential in ensuring their safe and effective use by patients and healthcare professionals. As the number of countries included in each study can be extensive (with each having specific regulatory content, phrase and language requirements), so the process of designing and printing booklets takes more time and effort, leading to greater risk of error.

Prisym 360 is a validation ready cloud-based label printing platform that is simple, standardized and scalable. Its unique features include automated booklet design, phrase and translation management, integrated change request and approval workflows, and flexible on-demand/Just-in-Time (JIT) print models. In addition, the integrated Vision print inspection simplifies, automates and reports in real-time on both the content and design of every printed label.

Clinical labeling regulations require 100% labels are inspected for errors, but manual visual inspection of printed labels is laborious, costly and error-prone.

Prisym 360’s MLT/CLT solution prompts users for study information, and then automates the generation of MLT, CLT and booklet design based on its knowledge of content and design requirements. This reduces clinical label and booklet creation from weeks to hours, ensures regulatory requirements are met and reduces risk of errors. Prisym 360’s Print Processes perform dynamic label generation, using label templates and logic to retrieve the latest approved content in real time to enable just-in-time printing and packing production models. This ensures the latest, approved expiration and dosages information is used, as well as enabling new supply models such as direct-to-patient. Prisym 360’s fully integrated Vision print inspection simplifies and automates real-time inspection on both the content and design of every printed label. This minimizes effort in inspection setup and operation, and identifies more errors at time of print.

Designed, tested, and delivered with a full validation documentation pack, Prisym 360 provides certainty that labels, and booklets are produced accurately, efficiently, and compliantly to support today’s complex, adaptive clinical studies.

For more information on any of the above products and capabilities, please get in touch here.

About Clinical Trials Innovation Programme 2022

Clinical Trials Innovation Programme is an invitation-only, premium event bringing together a mix of clinical research professionals and service providers in one stimulating environment.

Join us face to face to learn from the best in the drug development industry and have an opportunity to learn from their experiences. With an agenda covering the future of Clinical trials and drug development post COVID, Clinical Trials Innovation Programme 2022 will feature tailored sessions presented by the leading experts from across the globe.

We are bringing together the best in the industry to help you learn and grow, and accelerate your drug development journey. The experts will include thought leaders and visionaries from Danish Medicines Agency, Bayer Pharmaceuticals, AstraZeneca The Janssen Pharmaceutical Companies of Johnson & Johnson, Travere Therapeutics, Biogen, Vifor Pharma, Medical Products Agency and much more.

Register with us to learn more!