Project Description

The challenge

In order to adopt new European legislation and ISO standards, the EMA required a strategic partner to prepare EudraVigilance for signal detection and risk management.

Kinapse was selected in a European open procurement procedure and awarded a four year unit-price contract.

In order to achieve this objective, data quality needed to be enhanced for both the retrospective data set collected from marketing authorisation holders for centrally approved products as well as prospective data continually submitted through individual case safety reports (ICSRs).

This initiative was a top priority for the EMA as part of its 2015 Roadmap to enhance public health in Europe.

“The Kinapse team has performed extremely well, reaching productivity and quality targets well ahead of schedule, and now delivering at higher than expected productivity.”
European Medicines Agency

Our approach

Kinapse collaborated with EMA to design a program with 5 workstreams in scope:

  • ICSR duplicate detection.
  • ICSR manual recoding.
  • ICSR quality analysis and reporting.
  • EVMPD (EudraVigilance Medicinal Product Dictionary) validation and updates.
  • ICSR translation.

Kinapse starting working with the EMA on 1 Sept 2010 in setting up the project. This involved the establishment of processes and procedures, IT set up, the training and accreditation of Kinapse and contractor staff, and the development and testing of a data management tracking tool.

The Kinapse team went into production, as planned, on 2 December 2010.

“The experience during set up and now in production is extremely positive. The Kinapse team is well-organized and professional, and has partnered very effectively with EMA in flexibly addressing any issues as they have arisen.”

The result

The project was a success:

  • All of the workstreams were set up and made operational well in advance of scheduled milestones.
  • More than 99.9% of workstreams were of “right first time” quality.
  • Productivity at or above expectation within 3 months of workstream go-live date (versus 6 month ramp up plan to full productivity).

Costs of program 100% compliant with European Medicines Agency (EMA) expectations.

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