Patient safety redefined. Digitised, personalised and optimised.
Patient safety redefined. Digitised, personalised and optimised.

Our services

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.
Axian workshop with a large group

Risk Evaluation and Mitigation Strategies (REMS) and Additional Risk Minimisation Measures (aRMMs) ensure the safe and effective use of medications or medical products that pose significant risks to patients.

These strategies may be required by regulatory agencies, such as the FDA in the United States or the EMA in Europe, as part of the approval process for drugs with known or potential serious risks.

We promote a digital-first approach supported by paper options where needed.

REMS

REMS strategy development

REMS design and development:

  • Full REMS document suite
  • Operational model
  • Educational materials development
  • Digital system design, build and validation
  • Prototyping and stakeholder testing of digital systems and materials
  • Vendor selection
  • Design of REMS evaluation
  • REMS training

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

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:

  • Design, prototyping, and user testing of digital systems and materials
  • Digital system build and validation
  • Design and creation of educational materials
  • Strategy for effectiveness evaluation

Implementation services including:

  • Operational model
  • Integration with launch activities
  • Regulatory support for local submissions
  • Training
  • Vendor management
  • Fully supported multi-country implementation and hypercare

Ongoing maintenance and support

Consulting

Benefit-risk assessments and optimised risk management
consulting working group

Safety consulting services
With a wealth of knowledge and expertise and collaborations with clients in pharmaceutical companies ranging from small to large, we are uniquely positioned to assist you in the following areas:

  • 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

Technology

Cloud-based platform for multi-product, multi-country (including language) deployment and evaluation of risk minimisation solutions.
Axian One logo

Visit the Axian One page for information about our platform.

Contact us

  • The Bradfield Centre
    184 Cambridge Science Park
    Cambridge
    CB4 0GA
    United Kingdom
  • Axian Consulting US Ltd
    6200 Stoneridge Mall Road
    Corporate Commons
    Pleasanton
    CA 94588
    USA