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Integrity Solutions Europe
T.
+44 (0) 20 8793 9531
F.
+44 (0) 20 8793 9531
E.
contact@integrity-solutions.co.uk
Integrity Solutions Japan
T.
+81-3-6420-0775
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+81-3-6420-0162
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contact@integrity-solutions.co.jp
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Testimonials

"Responsive, reliable and knowledgeable.  Integrity Solutions have been a great partner in projects we have undertaken together at Allergan"
Ka-Wai Chan, R&D Information Systems, EU and AP

Case Studies

BACKGROUND

  • Project and Validation Management for Global Pharmacovigilance and Clinical Safety System
  • Solution roll out in the US, Europe and Japan
  • Short implementation window
  • Historically different ways of working across regions

OBJECTIVES

  • Sourcing a cost effective, fit for purpose supplier and solution
  • Harmonisation of PV processes across regions and organisations
  • Compliance with global regulations and E2B requirements
  • Harmonise and optimise computer system validation to minimise additional effort at sites

ROLE

  • Establish global project team structure, steering committee, core central team, regional coordinators and implementation teams
  • Requirements Definition, Programme, Risk, Cost and Resource Management
  • Validation integrated with supplier approach, leverage supplier effort and documentation where possible
  • Maintain communication with authorities for E2B testing
  • Manage global validation team

OUTCOMES

  • Harmonised global PV processes
  • Validated solution across regions
  • Project delivery to time and budget

CHALLENGES

  • Data Migration from multiple and varied existing PV systems
  • Different working practices and cultures across regions
  • Go live planning synchronised to regulatory reporting deadlines
  • Gaining buy in to change and system ownership accountabilities

BENEFITS

  • Effective sharing and reporting of safety data across regions
  • Resource mobility across regions due to harmonised processes
  • Compliant with current E2B reporting requirements
  • Lower global system management costs
  • Successful regulatory inspection
  • Effective sharing and reporting of safety data across regions