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Bespoke Study Design

Never an off the shelf solution, we construct the most appropriate study design and data source based on the needs of your project.

Collaborative RWE Experts

Our teams deliver optimised, robust studies, benefiting from diverse, comprehensive knowledge spanning all corners of RWE and beyond.

Pragmatism & Innovation

Combining practicality with bespoke time-saving innovations to generate evidence aligned to RWE recommendations, as efficiently as possible.

Our RWE team have a deep understanding of global and regional markets to best support the logistical and scientific challenges that RWE studies can present, with experience spanning:

RWE Strategy

  • Evidence gap analyses
  • Evidence generation recommendations
  • Data source mapping
  • Feasibility studies
  • Target trial protocols
  • RWE landscape analyses
  • RWE communication planning

Primary Data Generation

  • Prospective observational studies
  • Clinician surveys
  • Patient surveys
  • Preference studies
  • Delphi panels
  • Expert elicitation studies
  • Qualitative studies

Secondary Data Analysis

  • Insurance claims database studies
  • Primary/secondary care database studies
  • Registry studies
  • Medical chart reviews
  • Social media analyses
  • Literature reviews

Evidence Synthesis

  • Feasibility assessments
  • Meta-analysis
  • Indirect treatment comparison
  • Network meta-analysis
  • Population-adjusted analyses
  • Patient-level data meta-analyses

Projects are delivered by our specialised team of statisticians

How can Costello Medical meet your RWE needs?

Our RWE team can support you with evidence generation for a wide range of gaps, including:

  • Disease epidemiology, treatment patterns and patient pathways
  • Healthcare resource use and disease burden
  • Patient experience and quality of life
  • Comparative effectiveness (including external control arms)
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RWE Strategic Support

Using our extensive experience in Market Access and HTA, our team help to devise a RWE generation plan that underpins your product’s value proposition. To support our client’s strategy, our RWE experts can:

  • Assess your value proposition and identify evidence gaps
  • Provide a range of evidence generation recommendations
  • Identify and access suitable data
  • Design and conduct RWE studies to complement evidence gaps
  • Communicate findings to stakeholders
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Primary Data Studies

Where bespoke evidence collection is required, we have a wide range of expertise and capability in primary data studies. We work with our clients to understand their specific needs and employ the most appropriate study design to comprehensively address your research question.

We offer a full study management service ensuring the smooth operation of your project, including:

  • Study site selection, contracting, set-up and payment
  • Essential document development
  • Management of ethical assessment
  • Compliant data extraction and management

Get in touch with Miranda Townsend, our Study Management Services Lead, for more information.

With our dedicated in-house Patient Engagement team, we are fully equipped to design and conduct studies to generate primary data. Our team partners with Patient Advocacy Groups to recruit study participants and ensure patient-centric research. Additionally, we can collaborate with panel recruitment vendors to recruit participants.

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Secondary Data Studies

Where pre-existing data exists, our RWE experts can support clients to generate evidence and insights from secondary data studies. Our highly skilled team of Epidemiologists, Statisticians and Analysts can support throughout the project process, including:

  • Study conceptualisation and planning
  • Protocol and statistical analysis plan development
  • Data procurement and analysis
  • Generation of meaningful insights and evidence
  • Communication of findings

High-quality RWE generation begins with selecting the best data source. We offer a full data source mapping service, identifying, characterising and critically assessing relevant sources, ensuring that all appropriate information is at your fingertips.

By strategically leveraging the most suitable data sources based on the research question in hand, we can efficiently produce high-quality, credible evidence that resonates with stakeholders.

Real-World Evidence Digital Week 2023

Declan Summers, Costello Medical’s Deputy Head of Real-World Evidence, 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.

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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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