Clinical Outcome Assessments

We work with you to protect and licence high-quality, validated Clinical Outcome Assessments (COAs), so meaningful, patient-centred evidence can be used with confidence.

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OUI and Clinical Outcome Assessments

Clinical Outcome Assessments (COAs) help us understand what’s really happening to patients during treatment — how they feel, how they function and how their health changes over time. They often take the form of questionnaires or performance-based measures and, when carefully developed and validated, provide trusted evidence of treatment impact.

Because of the expertise and research behind them, COAs are also valuable intellectual property (IP). Protecting them properly helps make sure they can be used consistently, responsibly, and to their full potential. 

We currently support five main types of COAs: 

  • Patient-reported outcome (PRO) measures (sometimes called PROMs) 
  • Patient-reported experience measures (PREMs) 
  • Observer-reported outcome measures (ObsRO) 
  • Clinician-reported outcome measures (ClinRO) 
  • Performance outcome measures (PerfO) 

If you’re an academic developer, we’ll work alongside you from an early stage, offering practical support around funding, market landscape reviews, translatability and digital considerations. 

We also help protect the copyright of the COA, manage licensing and liaise with external organisations to make sure they’re used appropriately across research, clinical trials and healthcare settings.

​Explore our COAs

Developing COAs

A well-designed COA should capture meaningful health information in a scientifically robust way, while also meeting the expectations of patients, researchers, regulators and future users. 

That’s why early support can make such a difference. We work with academic teams to help shape a clear development pathway, from protecting the IP to dissemination and future licensing. 

Getting in touch early helps safeguard your work, clarify next steps and position your assessment for wider use by healthcare and industry partners worldwide. 

Translation and linguistic validation

COAs are often used internationally, so high-quality translation and cultural adaptation are essential. We manage a growing library of translations across our portfolio to support use in multi-country studies and global healthcare settings.  

Where new languages are needed, we can coordinate translation and linguistic validation services ​​aligned with recognised best practices, including ISPOR recommendations and regulatory expectations from agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This helps keep translations conceptually equivalent to the original, supporting scientific integrity across languages and culture contexts. 

If you’re developing a new COA, we can also advise early on translatability. A quick review at the right time can help identify wording or concepts that may be difficult to translate later, supporting smoother adoption and reducing the need for major revisions.  

eCOA migration

As healthcare research increasingly moves into digital environments, electronic COAs (eCOAs) are becoming more widely used. Instead of paper questionnaires, data is collected through tablets, smartphones, laptops or other digital platforms. 

Digital formats offer real advantages, including improved accessibility, reduced administrative burden, real-time data capture and fewer data-entry errors. However, not all formats suit every population or study context. Choosing the right approach early can save time later. 

We work with academic teams early on to think through content choices that could affect future digital use. We also offer guidance on suitable digital platforms for validation studies and wider dissemination. 

If a COA is later migrated into an electronic format by a licensee, we review the digital version to make sure it stays true to the original instrument and supports comparable measurement. 

We use recognised best-practice guidance to review and test (where appropriate) each eCOA migration. Once complete, we issue a letter of authorisation confirming that the eCOA is a faithful reproduction of the original. 

Our portfolio

Our growing portfolio includes validated COAs developed across the University of Oxford, including the Nuffield Department of Population Health, along with selected measures from external organisations. 

These are largely PROMs and ClinROs, spanning a range of therapeutic areas and indications, including: 

  • Orthopaedics 
  • Neurology – such as Parkinson’s Disease, Motor Neurone Disease  
  • Genetic – such as Duchenne Muscular Dystrophy 
  • Women's Health – such as Endometriosis 
  • Rheumatology – such as Vasculitis 

See how our COAs are being used in practice.

Explore our portfolio
Contact the Clinical Outcomes team

Got any questions?

Whether you are an academic developing a new outcome measure or an organisation looking to licen​se a trusted, validated COA, we’re here to help.  

We’ll make sure the process is clear and well supported throughout – so you can be certain the COA is fit for purpose and can be used with confidence.  

Get in touch

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