Based upon its collaborative work with three 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.
“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,” Simon Jones, vice president of product marketing, said. “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.”