High quality, high productivity and scalable: AstraZeneca's new global case-handling system

As the dust of mergers settled, AstraZeneca emerged assessing the impact of its marketing and development plans on pharmacovigilance.  'Dramatic' was the conclusion.  In 2002, the Clinical Drug Safety Team processed over 50,000 individual adverse event (AE) case reports globally.  Broadly harmonised but with a lot of local variation, the system funneled reports worldwide from seven collecting sites in Europe and the USA to a central database.  It worked.  But, continuing growth in the products and drugs portfolio would take the annual case report figure well past the 100,000 mark by 2007.  Growing a quality workforce to match was currently pure fantasy. AstraZeneca's Clinical Drug Safety Team decided that they must re-engineer their case-handling process to achieve the vast productivity increase approaching whilst maintaining the highest quality.

AstraZeneca's challenge was to establish a smooth, timely case-handling process that collected data into one global database.  The data had to be consistent in structure and meaning, compliant and of the highest quality.  The system needed to be fully operational by Q1 of 2004 and futureproof, so that by 2007 productivity was at least 25% higher to prevent backlog.  Success would bring annual savings of $3.3 million as well as a sound basis for confident growth.  AstraZeneca asked WCI to help.

If you would like further information about our work with AstraZeneca please click on the pdf. below.

Pharmacovigilance for the future