Date: 12th June 2012
Cambridge, UK, June 12th 2012—Pharma eReport, a software and services company that delivers a comprehensive EVMPD compliance solution for pharmaceutical regulatory professionals, today announces the launch of its “Collate, Convert & Comply” Excel spreadsheet data import service, which enables Marketing Authorisation Holders to quickly and easily import MA spreadsheet data into Pharma eReport’s Centrality XEVMPD software and convert it to compliant, syntactically-correct XML format. Pharma eReport has also made its Excel spreadsheet for data entry freely available on its website (Pharma eReport).
The new “Collate, Convert & Comply” service expedites data entry for Marketing Authorisation Holders and pharmaceutical regulatory professionals, providing total data import flexibility. The service is offered with custom interface and import capabilities, which gives MAHs the option to either import entire spreadsheet-based Marketing Authorisations into Centrality – Pharma eReport’s comprehensive EVMPD software suite – or to import whatever MA data is held in spreadsheet format and then complete it manually within the Centrality platform.
The two-stage import process begins with an initial population of Centrality’s ‘Element’ library from the spreadsheet data. The imported data is automatically de-duplicated against existing entries and data elements in the database, to ensure robust lifecycle management – meaning that if a data element changes in the future, all dependent EudraVigilance Product Report Messages (EVPRMs) will be automatically flagged for re-submission. In the next stage, the EVPRM is constructed by gathering all the data elements as described in the imported spreadsheet, ready for compliant submission to the European Medicines Agency (EMA).
A key additional service feature is the built-in ability for customers to request auto-translation of individual Controlled Vocabularies descriptions to the appropriate EV code. The Centrality tool has been designed from the ground up for ultimate flexibility in providing accurate and seamless custom translation.
Commenting on today’s announcement, Marco Rubinstein, CEO of Pharma eReport said: "With the 2nd July 2012 EVMPD deadline fast approaching and Marketing Authorisations Holders now heavily involved in the huge data collation effort that compliance requires, our goal is to make the data entry process as smooth and hassle-free as possible for our customers.” He added: “Many of our customers hold data which they have extracted from their current pharmacovigilance software – often from more than one system – and usually output into Excel format. Our new “Collate, Convert & Comply” service relieves customers from having to tediously re-enter all this data, and provides a fast, easy and flexible service that is custom-engineered to interface with their existing systems and processes.”
To sign-up online for a Centrality software user account and to register interest in Pharma eReport’s “Collate, Convert & Comply” service, please visit: Pharma eReport
nicky [at] pharmaereport [dot] com
About Pharma eReport (Pharma eReport)
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.