Real-World Evidence

Harness the power of RWD to optimise your capacity to deliver the right treatments to the right patients by partnering with Aixial’s team of flexible experts. We can support you with study design, conduct, analysis, interpretation and communication of the results.

The strategic power of real-world data in healthcare

Real-World Evidence (RWE) transforms real-world data (RWD) into actionable insights that support informed decision-making across healthcare and life sciences. Unlike data generated through traditional clinical trials, RWD is collected from a wide range of real-world sources, including electronic health records, claims databases, patient registries, and wearable devices. Generating robust RWE requires rigorous study design, advanced analytical methods, and deep expertise in pharmacoepidemiology, biostatistics, and data science to ensure reliable interpretation and meaningful outcomes.

Why engage in RWE generation?

Early stage


  • Disease prevalence and incidence
  • Disease burden
  • Patient profiles
  • Patient management
  • Effectiveness and safety outcomes under standard of care

Trial design & conduct


  • Trial feasibility
  • Site selection
  • Sample size considerations
  • Externally controlled trials
  • Pragmatic trials

Post approval


  • Generate evidence required for coverage and payor decisions
  • Assess the product’s impact in routine clinical practice
  • Monitor long-term safety of marketed products
  • Position the product against the competition

Our teams are skilled in descriptive studies in which sample representativeness is key, as well as comparative methods.

What we can deliver


Post-authorisation safety studies (PASS) and drug utilisation studies (DUS)

Studies requested by local health authorities, including quality of life studies

Evidence synthesis, including meta-analyses and indirect treatment comparisons

Design

  • Complex sampling when representativeness is required
  • New-user designs
  • Restriction
  • Active control groups
  • Propensity score methods
  • Matching
  • Case-only designs (self-matched/controlled methods)

Analystics

  • Multiple imputation to address missing covariate data
  • Stratification
  • Standardization
  • Regression analyses
  • Disease risk scores
  • G-methods, including marginal structural models (MSMs)
  • Negative controls and quantitative bias analyses

How can your organisation benefit from our services?

Multidisciplinary teams

With diverse backgrounds and decades of experience in interventional and non-interventional studies

Proactive teams

That go beyond simple study execution and can assist you in the elaboration of your evidence generation plans and act as a strategic partner

Flexible team structures

That adapt to the sponsor needs to generate meaningful, useful evidence

Speed & scalability

The possibility to rely on in-house tools designed for speed and scalability

How can we support your next project?

Whether you’re looking for a protocol review or a proposal,

simply reach out to us by filling our request for proposal.

Insights