Kinapse selected by European Medicines Agency to provide EudraVigilance data management services
pharmafile | October 25, 2010 | News story | Business Services | EMA, Kinapse
25 October, 2010
London, UK
Kinapse announced today that it has been selected through a European open procurement procedure to provide data management services to the European Medicines Agency (EMA). The estimated contract value is € 6,500,000.
The scope of the agreed framework contract covers detection and management of duplicate Individual Case Safety Reports (ICSRs), manual recoding of medicinal product information contained in the ICSRs, data validation and cleaning of medicinal product information in the EVMPD, quality control of ICSRs and translation of case narratives in ICSRs.
Andy Black, Kinapse Chief Executive Officer commented “We are delighted that the EMA has entrusted Kinapse to successfully deliver this critical priority. We will be making every effort, in close collaboration with the EMA, to enhance the quality of the data residing within EudraVigilance over the next four years. This contract enables Kinapse to play an important role in supporting the enhancement of pharmacovigilance across the European Union and globally, together with our delivery partners the International Institute for the Safety of Medicines (ii4sm), QSI and RWS Translation Services.”
“We are very pleased that we have been chosen to provide pharmacovigilance expert consulting and quality assurance services to EMA in collaboration with Kinapse” said Dr. Roland Haag, CEO ii4sm. “This important contract is a recognition for ii4sm as a comprehensive provider of specialized safety services for the life sciences sector.’’
Kinapse Ltd.
About Kinapse
Kinapse provides consulting and outsourcing services to the global life sciences industries.
Our clients include many of the world’s leading pharmaceutical, biotechnology, medical device and specialty pharmaceutical companies, government organisations and life sciences service providers.
Kinapse specialises in addressing the challenges of life sciences. We understand the complex issues faced throughout the life sciences value chain and offer innovative insights, advice and service delivery to our clients.
Contact:
louiza.senaini@kinapse.com, info@kinapse.com, +44 (0)208 946 7600
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