Global real-world evidence (RWE) pilot study in antimicrobial resistance (AMR)

Global real-world evidence (RWE) pilot study in antimicrobial resistance (AMR)

Global real-world evidence (RWE) pilot study in antimicrobial resistance (AMR)

Global real-world evidence (RWE) pilot study in antimicrobial resistance (AMR)

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Global real-world evidence (RWE) pilot study in antimicrobial resistance (AMR)

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Global real-world evidence (RWE) pilot study in antimicrobial resistance (AMR)

Real World Evidence Case Study

Real World Evidence Case Study

Real World Evidence Case Study

Client: TOP 10 PHARMA

Client: TOP 10 PHARMA

Client: TOP 10 PHARMA

The Challenge

The sponsor had a long track record in global AMR surveillance, traditionally reliant on central labs to process and report microbiological data.

But this time, they wanted something more flexible. A faster, decentralised approach that could collect anonymised real-world data — both microbiological and clinical outcomes — directly from hospital sites.

Micron was tasked with enabling this shift: Build a solution that would accept structured data from local LIMS (Laboratory Information Management Systems) where possible, and manually where necessary — all while maintaining data integrity.

Micron’s Contribution

We activated 21 study sites across five countries:

🇮🇳 India, 🇲🇽 Mexico, 🇸🇦 Saudi Arabia, 🇪🇸 Spain, and 🇬🇧 the UK.

Depending on technical capability, each site submitted anonymised data:

  • Electronically via their LIMS

  • Or manually, supported by Micron’s onboarding and data teams

In total:

  • 8,060 hospitalised patient records were submitted

  • 7,444 (92%) were complete enough to include in the final analysis

  • All data was coded and processed by Micron’s internal data management team

To empower real-time use of the results, we built a secure, web-based portal where both study sites and the sponsor could view and analyse the AMR dataset via a custom database interface.

The Result

This pilot study successfully demonstrated the feasibility of using real-world data — including anonymised EHR and microbiological results — to track AMR and patient outcomes across international hospital sites.

Key takeaways:

  • The approach is scalable. This methodology can be applied to other therapy areas beyond AMR.

  • Flexibility is critical. Sites varied significantly in their data quality and technical infrastructure. A rigid, one-size-fits-all model wouldn’t have worked.

  • Data completeness matters. Compared to clinical trials, real-world EHRs may be relatively incomplete. But with the right tools and a site-aware strategy, valuable insights are still achievable.

TOP 10 PHARMA

TOP 10 PHARMA

TOP 10 PHARMA

"Team members are fully engaged and take responsibility for the studies as if they were their own."

Project Manager