Clinical Trial Information System for Clinical Trial Application in Europe

Say hello to the Clinical Trials Information System (CTIS)! The single entry point for all clinical trial applications (CTAs) in the EU and EEA created by European Medicines Agency (EMA) that enhances transparency, safety, and data reliability.
Zwiers Regulatory Consultancy BV, proud member ProductLife Group, have experience with clinical trial strategy, CRO selection, and management, preparing clinical trial documents like Protocols, Investigator’s Brochures, and CTAs.

General Cross functional PV collaboration

As a crucial way to ensure medication efficacy and safety, cross-functional collaboration between different departments in a pharmaceutical company ensure to identify and address adverse events promptly. This latest article explores the importance of cross-functional pharmacovigilance collaboration and provides some tips for facilitating it.

5 Key Points to master the Digitalisation for Labs of the Future (LotF)

LIMS, ELNs, Cloud-Based Computing, the Internet of Things (#IoT), AI, Machine Learning, Automation & Robotics, Lab Wearables, and Augmented Reality… All available technologies that could make Labs of the Future a reality.
The possibility of using IT to create fully integrated, digitalized processes in the lab to enable advanced data analytics and increase efficiency sounds promising. Discover PharmaIT Director of Laboratory Informatics’ key elements to consider in the pursuit of LotF!

 

Crisis Management: solution to a Stock-out Situation

How do you deal with a crisis? ProductLife Group can tell you how we supported our client dealing with one.
We recently had a client facing an “Out of Stock” Crisis on several of their products in France. We were able to help by providing additional resources to manage their increased call volumes.

Breaking news! PLG as a Fit4Innovation partner

Proud to have been chosen as a partner by the Fit 4 Innovation program, PLG supports SMEs and startups in Luxembourg looking to launch innovative digital medical devices in Europe. PLG’s partnerships with EIT Health and other innovative institutions allow us to stay ahead of the curve and evolve our services to complement industry advancements.

PLG, your new EIT Health's ULab partner

PLG has been selected by EIT Health to join the User Validation Labs program as a partner to support European start-ups in designing, organizing and executing validation studies for their innovation.

PLG will focus on helping the validation their go-to-market and regulatory strategies, based on our expert assessment of users’ needs, profiles, and intended uses.

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March 2023 Monthly Newsletter