Date: 21st March 2012
Cambridge, UK, March 21 2012 - Pharma eReport, a software and services company that delivers a comprehensive EVMPD compliance solution for pharmaceutical regulatory professionals, today announces that its Centrality software suite is now in full general availability, incorporating the latest specification changes from the European Medicines Agency (EMA) issued on 5th March 2012. The software has been fully tested to compliantly generate valid, syntactically-correct XML data. Prospective customers can sign up and register for the software online now.
Pharma eReport – a subsidiary of ELC Group, the pan-European pharmaceutical regulatory affairs organisation – offers a full service solution to help Marketing Authorisation Holders (MAHs) meet the July 2nd 2012 deadline for mandatory EudraVigilance Medicinal Product Dictionary (EVMPD/XEVMPD) data submissions. Pharma eReport’s flagship Centrality software suite and specialist EVMPD services – delivered by a Key Support Services team of qualified chemists – provide a comprehensive, quality-assured EVMPD compliance solution that is available to customers now.
Pharma eReport’s Centrality software allows MAHs to easily convert existing medicinal product information into an XML Schema Definition (XSD)-compliant format, and seamlessly upload the required data as a EudraVigilance Product Report Message (EVPRM) using an approved submission mechanism. All software database elements as well as the XML output are directly driven from officially mandated EMA schema, and subject to stringent testing and QA procedures. The software is secure, easy to use and custom-engineered for flexible implementation, including development support for bespoke interfaces to provide full harmonisation with customers’ existing systems. Centrality allows the import and export of XML and CSV files, enabling total ease of integration with all existing enterprise and pharmaceutical regulatory software platforms and product life cycle management systems.
The Centrality software is offered via a transparent pricing model and with fully flexible deployment options. The Centrality platform is available as a secure, on-demand cloud-based application (Software-as-a-service) accessed via a standard web browser, or it can be installed as a standalone software application. For customers who wish to have all their data in-house, Centrality can be installed on a company intranet, so that the data is held on-site and authorised users can access it securely via the company system. The Centrality software solution is completely independent – no other software needs to be installed – and offers full support for both Windows and Linux.
Pharma eReport also provides a full range of Key Support and consulting service, including data collation, organisation and mapping capabilities, to help customers meet any challenge related to EVMPD implementation and ensure timely compliance with the EMA mandate.
Commenting on today’s announcement, Marco Rubinstein, CEO of Pharma eReport said: "We are delighted to be launching our Centrality software into full general availability today. Now is the critical time period for Marketing Authorisation Holders to select a software partner to help them meet the July 2012 EVMPD compliance deadline and we’ve worked hard to ensure that our Centrality solution is easy-to-use, fully compliant, secure and future-proof, offering the highest quality assurance and the best solution possible for our customers.” He continued: “The schema-derived nature of our platform means that any EMA specification changes – and, indeed, any intermediate schemes ahead of the planned ISO IDMP (Identification of Medicinal Products) standard – can be quickly and seamlessly incorporated into our platform. We’ve designed Centrality from the ground up to provide a total solution for managing ongoing, database-wide pharmacovigilance updates and ensuring continuing EMA regulatory compliance. We’re looking forward to helping our customers meet the short-term EVMPD compliance challenge and continuing to support them in a long-term, successful partnership.”
To sign-up online and become a registered user of Pharma eReport’s Centrality software, please visit: http://www.pharmaereport.com
nicky [at] pharmaereport [dot] com
About Pharma eReport (http://www.pharmaereport.com)
Cambridge, UK-based Pharma eReport provides intuitive electronic product data management and reporting software for pharmaceutical regulatory professionals.
With its flagship Centrality software suite and supporting specialist EVMPD services – delivered by a Key Support Services team of qualified chemists – Pharma eReport provides a comprehensive EVMPD solution, including complete outsourced data collation, organisation and mapping capabilities. The Centrality software is available as an on-demand software-as-a-service (SaaS)/cloud-based solution – accessed via a standard web browser – or it can be installed as a standalone software application at a client site.
Pharma eReport is co-founded by the management of ELC Group – a leading global services company with recognised expertise in regulatory affairs and Marketing Authorisation management – plus former executives from electronic design automation software company Synopsys, Inc. Pharma eReport harnesses the unparalleled industry knowledge of its regulatory expert founders and combines this with a world-class software development team to deliver a total solution for EVMPD compliance and beyond.