All workstreams set up and operational well in advance of scheduled milestones.
Right first time quality on workstreams in progress >99.9%.
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 EMA expectations.
EudraVigilance data quality on track for compliance with EU legislation.
In order to adopt new European legislation and ISO standards the European Medicines Agency (EMA) required a strategic partner to prepare EudraVigilance for signal detection and risk management.
Fundamental to this objective is the enhancement of data quality of both the retrospective data set collected from marketing authorisation holders for centrally approved products as well as prospective data continually submitted through electronic Individual Case Safety Reports (ICSRs).
This initiative is a top priority for the EMA as part of its 2015 Roadmap to enhance public health in Europe.
Kinapse was selected in a European Open Procurement procedure and awarded a four year contract unit-price contract.
Kinapse collaborated with EMA to design a program with 5 workstreams in scope:
Best practice program management and performance management in line with agreed service levels with root cause analysis, CAPA for all identified issues.
Kinapse has been successfully audited by EMA.