Press release Guildford, UK 28 Oct.2014

Press Release Guildford, UK 28 Oct 2014 – PrimeVigilance Limited, a pharmaceutical service provider for Pharmacovigilance and Medical Information operations today announced the completion of a major upgrade of its core databases for pharmacovigilance and medical information-  ARISg™ 7 and agInquirer™. The new databases enable PrimeVigilance to better meet today’s demanding data challenges while delivering significant productivity gains with regards to automated production of information for report writing and client analyses. For its clients, this means PrimeVigilance can turnaround case processing and medical information inquiries faster whilststill retaining the highest quality.  Clients faced with challenging SDEAs can continue to turn to PrimeVigilance for excellent submission compliance.  In addition, PrimeVigilance can now offer clients access to a wider range of reports (e.g., metrics, data analysis) with the option to request specific customised outputs. PrimeVigilance have considerable experience obtained from the upgrade which was completed within 12 months.  A full suite of validation documentation is available including detailed user requirements specifications, validation plans, test scripts and validation reports.

Neil Clark, Director of PrimeVigilance said:Over the past 12 months, PrimeVigilance has invested in upgrading its processing systems and now has an up to date, fully validated, integrated system that can process both pharmacovigilance and medical information to the highest standards.  PrimeVigilance continues to be dedicated to providing high quality safety information services and consultancy to its existing and future clients and the investment in the system upgrade is a demonstration of that commitment.”

Upgrade Summary

PrimeVigilance has upgraded its PV system to ARISg™ 7. This updated version has enhanced capability including:

  • Fully automated workflow including automated prioritisation based on submission due dates
  • Workflow designed to incorporate client role in case processing if required
  • Paperless
  • Built in validation checks
  • Linked to Business Objects for customised reports
  • Fully validated
  • Standard Data Handling Conventions designed alongside the database implementation to ensure reporting requirements are met and data can be extracted / analysed as required
  • Provision of quality and compliance metrics
  • Management / Tracking of follow up queries
  • Full suite of SOPs to manage change control, disaster recovery and business continuity as well as set up and maintenance of client specific databases.

At the same time PrimeVigilance has established a Medical Information management and processing system called agInquirer™. The integration of the ARISg™ 7 database with agInquirer™ will support the seamless transfer of safety information from Medical Information to Pharmacovigilance.  This integration will share safety information from one system to another and improve the efficiency, quality and compliance by removing the need for manual transcription of data from one system to another. The advantages of agInquirer™ include:

  • Intuitive and simple interface
  • Designed for global collaboration
  • Web-based, and in the cloud
  • Multiple routes of communication
  • Accurate, efficient and timely responses
  • Repository of knowledge for the organisation
  • High quality, customisable reports
  • Creates a verifiable audit trail with enquiries tracked start-to-end
  • Validated

-END-

 About PrimeVigilance  The pharmacovigilance (PV) service offered by PrimeVigilance covers all the regulatory and scientific elements of PV required to obtain and maintain a product license within Europe: Qualified Person (QPPV),  a compliant PV System with robust Quality Management, consistent Adverse Event data capture, expedited reporting, literature screening, preparation of Periodic Safety Update Reports, signal detection and evaluation, benefit-risk assessment, Risk Management Planning, compliance auditing, support during crisis and ad hoc consulting assignments. PrimeVigilance also offers fully integrated international Medical Information services. PrimeVigilance has grown organically since 2008 and now has 100 staff employed in its main offices in Guildford UK, and Zagreb, Croatia, as well as an international network of consultants. PrimeVigilance is currently providing services across more than 100 countries.

For further information please visit www.primevigilance.com

or alternatively please contact:

Neil Clark, CEO Phone: +44 (0) 1225 731349

E-mail: neil.clark@primevigilance.com

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