Axian Consulting ltd.

Platinum Sponsor

Axian combines a deep understanding of the healthcare landscape with the power of digital technology to deliver innovative approaches to patient safety. We support you with the internal change management needed from inception to implementation of solutions. This means you maximise the potential of adopting digital approaches while satisfying all regulatory requirements.

End to end technology enabled services for REMS and aRMMs

Design, implementation, evaluation and continuous management of risk minimisation programmes.

aRMMs (EU and ROW)

Strategies and solutions for risk management  

• Design and development of aRMM solutions (digital and conventional), including controlled access and controlled distribution systems
• Implementation services including
• Ongoing maintenance and support

REMS

• REMS strategy development
• REMS design and development:
• FDA submission and negotiation support
• REMS launch and hypercare
• REMS programme management
• REMS assessment report design and execution including KAB surveys
• FDA inspection readiness 
• Vendor management and audit

CONSULTING

Benefit-risk assessments and optimised risk management

• Structured benefit/risk assessment
• Technology road mapping and selection
• Digital transformation / change management support for “digital first” approaches
• Process design and SOP development
• Centre of Excellence design

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