Our expertise

Gap analysis, data landscaping, and strategic support

We conduct rigorous gap analysis and identify the most suitable data sources to generate evidence to fill these gaps. All of our RWE projects are designed from the ground up; we are not limited to any proprietary data sources and can therefore tailor our approach to your specific evidence requirements.

Development of protocols and analysis plans

From the outset of each project, we bring together a core project team of disease specialists, epidemiologists and statisticians to design methodologically robust and clinically appropriate RWE studies that meet the identified evidence needs. Our protocols align closely with the Guidelines for Good Pharmacoepidemiology Practices (GPP) from the International Society for Pharmacoepidemiology (ISPE). Our transparent analysis plans provide a comprehensive description of each step of the analysis, from data cleaning to the final statistical models. Where necessary, we prepare all materials for ethics committee or institutional review board (IRB) approval and take on a full project management role for this process.

Analysis of diverse data sources

We design and conduct analyses using a wide range of data sources, including:

  • Healthcare insurance claims databases
  • Electronic medical record (EMR) databases
  • Disease-specific registries
  • Surveys of patients, clinicians and caregivers
  • Bespoke chart reviews
Studies on clinical and economic outcomes

We have conducted studies on natural history, clinical and economic burden of disease, treatment landscapes, and treatment outcomes. We understand the challenges of developing and validating algorithms to identify specific conditions or events in real-world data sources, and we collaborate closely with the client and external experts to ensure that each step in the analysis is clinically relevant.

Real-World Evidence Digital Week 2023

Declan Summers, Costello Medical’s UK Real-World Evidence Lead, recently presented a webinar alongside Sheela Upadhyaya focusing on the evolving role of real-world evidence in drug development. This session explores the recent shift in how real-world evidence is viewed by the pharmaceutical industry, with manufacturers increasingly considering RWE as an end-to-end solution that can be utilised throughout the drug development process.

Opinion piece illustration

NICE Real-World Evidence Framework

In June 2022, the UK National Institute for Health and Care Excellence (NICE) launched its real-world evidence (RWE) framework. Our RWE team was delighted to participate in the public consultation for the framework earlier this year and reflect on the potential impact it will have on the UK and global health technology assessment (HTA) landscape in this article.

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For more information on our Real-World Evidence services or to request a quote, please contact Amy Buchanan-Hughes

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