Updates will help to streamline label and booklet production for adaptive clinical studies
Based upon its collaborative work with three leading pharmaceutical companies, PRISYM ID has launched an update to its flagship software solution for clinical supplies labeling. Enhancements to PRISYM 360 include the automation of booklet production with improved regulatory rules and language management and a new compliance-friendly product – the 3-Step Clinical Label Print Process.
The update is part of PRISYM ID’s continued responsiveness to the needs of organizations undertaking clinical trials. Clients are seeking to leverage the latest technology improvements to be able to quickly launch studies in multiple countries at the same time, while building in flexibility to allow for subsequent drug dosage or administration changes. They need processes which are fully auditable, are logged and that offer traceability for every printed label or booklet.
The 3-Step Clinical Label Print Process encapsulates industry best practice, significantly reducing the possibility of individual user error when printing single page labels. It will not let the same person raise and approve labels, it ensures a test label is printed and stored electronically, prints test labels with a watermark, and creates summary reports and audit trails.
New content management controls are designed to merge the right rules and phrase content together for particular drugs and protocols, and ensure they are produced in the right languages for the countries in which trials are run. They can replace email and disparate, clunky systems that have manual steps and are liable to user error.
Simon Jones, Vice President Global Product, said: “We have worked closely with three key customers who explained to us their challenges in quickly creating multi-page booklets for studies in 40+ countries, especially where participating countries have specific regulatory requirements in respect of language, indications, warnings, precautions, and symbols.
“This update is therefore all about clinical trial functionality enhancements which streamline the process of creating a label or a booklet and getting clinical trials started more quickly. Our 3-Step Clinical Label Print Process eliminates errors, risks and ensures full accountability.”