PRISYM ID exhibits at Partnerships in Clinical Trials Europe
- PRISYM ID to address the importance of end-to-end label lifecycle management within clinical trials -
We will be exhibiting on stand 151 at the Partnerships in Clinical Trials Europe exhibition & conference, 16th & 17th November 2016, Vienna.
The conference will bring together industry leaders and market participants - from regulators and patient advocacy groups, to pharmaceutical and biotech firms and providers – to create a single vision of current reform and innovation within clinical trials. Speakers, delegates and exhibitors will discuss the latest insights and best clinical practices to accelerate clinical development and improve trial quality.
Steve Ellison - PRISYM ID, comments: “Clinical trials are increasingly a global activity with clinical trial materials being shipped across many countries and many continents. For the sake of patient safety, the ability to control these materials’ labels at a global level is paramount. Labelling, booklets and where necessary PIL’s - patient information leaflets must be safely and accurately customised not only so that they are in the appropriate local languages, but also ensure country specific nuances of including country specific designs and regulatory requirements are understood sufficiently to communicate coherently with users.”
Global clinical trials labelling is a complex subject. To control clinical trials labelling on a global scale three main functions need to be managed:
- Complexities around local language labelling
- Managing source data for labels, booklets and PILs
- Customising labels for country specific requirements
These functions are represented by a number of stakeholders including those responsible for the regulatory submissions, defining the protocols and the various approvals that take place throughout the complete lifecycle, including but not limited to:
- Pharmaceutical R&D
- Clinical supplies organisations
- Booklet and label printing companies
As such, the importance of centrally managed, efficient and effective partnerships is increasingly being recognised; not least of which the importance of label lifecycle management in the end-to-end print process.
At Partnerships in Clinical Trials Europe, at stand 151, PRISYM ID is pleased to present its complete solution PRISYM 360 for managing clinical trials labelling on a global scale – from local language labelling to country specific design. A turn-key solution which follows clinical trial protocol to help in passing industry specific audits including FDA and MDR, PRISYM 360 also features inbuilt security, which only allows authorised users to create, edit or print labels as well as monitor their activity.
The software supports clinical trials phase label printing, patient stratification, patient removal during a trial, multiple centre, visit and treatment logging management, complete randomisation based on treatments and stratification and product lifecycle documentation.
Steve concludes: “The clinical trials industry sits on the verge of globalisation. As such, it has never been of more significance for all stakeholders to come together to discuss the importance of new technologies and partnerships to enhance workflows, ensure efficiency and ultimately patient safety. The Partnerships in Clinical Trials Europe event is an important opportunity for everyone involved. It offers the chance to share practical knowledge and advice on the current regulations and help the whole industry to prepare for the expanding global market.”
To arrange a meeting, book a place on PRISYM ID’s stand or discuss your organisation’s specific needs, please contact Steve via firstname.lastname@example.org.