Patient-first solutions to the most challenging diseases
Every day, we provide bespoke solutions to leading pharmaceutical companies in order to tackle the world's most challenging diseases.
You'll get a top team of experts in patient-centred outcomes research, including Co-Editors of leading journals Value in Health, Orphanet Journal of Rare Disease, Journal of Patient-Reported Outcomes, PharmacoEconomics and Medical Decision Making. We also hold key roles in global groups such as ISPOR, EuroQol, and ISOQOL.​, so you're in good hands.
Patient-reported outcomes (PRO) / clinical outcome assessment (COA) strategy and instrument development
We need a COA / PRO strategy that addresses the needs of multiple stakeholders
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We need help communicating our PRO / COA strategy with regulators
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We’ve been told the PRO / COA we have or plan to have in our trials is not fit for purpose. What can we do?
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There is no disease-specific measure. Do I need to develop a new PRO / COA?​
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How can we demonstrate meaningful difference or meaningful change to support our label claim?
A well-developed PRO / COA strategy is essential for pharmaceutical and biotechnology companies aiming to enhance patient-centric care, streamline clinical research and navigate regulatory processes effectively.
Our holistic PRO / COA strategies consider the needs of multiple stakeholders, including patients and caregivers, clinicians, regulators and HTA agencies. We are experienced in identifying evidence needs, executing studies to plug any qualitative and psychometric evidence gaps, and developing robust FDA / EMA evidence packages to support regulatory interactions. We also develop guidance and training to support with internal discussions.
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Whether it’s a thorough strategy incorporating qualitative and quantitative work streams, instrument development and stakeholder-interaction plans, or a more pragmatic piece of desk research, we tailor robust PRO / COA strategies to capture and communicate meaningful patient data.
Psychometrics
Will this measure work in my small rare-disease sample?
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Is this measure fit for purpose as a key endpoint?
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Is this measure biased?
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Can we compare scores from these two measures?
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How sensitive is this measure across different severity groups?
Alongside standard psychometric validations (structural assessment, reliability, validity etc.), we offer a huge array of tailored psychometric analytic approaches from both classical test and item response theory to help you tackle complex questions around your PROs / COAs and provide evidence needed for regulators.
Worried about whether a measure can detect change or whether it is biased? By applying differential item functioning techniques, we can assess in detail the performance of items across time and groups. Measure too long? We can offer informed advice on the reduction of items whilst maintaining the reliability and performance of the test. Different measures used in your study? We can help equate scores so responses can be directly compared.
If these sound like the type of questions you are asking of your measures, come and discuss a tailored solution with us.
Analytics & data visualisation
Our patient-reported outcomes were all exploratory. How can we use them?
Our patient-reported data doesn’t support our clinical data — what’s going on here?
How can we use our patient reported data to differentiate from competitors?
How can we use our data to communicate with different stakeholders?
How are symptoms and effects interacting overtime in different patient groups?
How can we present this complex analysis to patients or clinicians?
Data and results can pose more questions than they answer. Sometimes, there is an idea, but it isn’t immediately clear how to tackle it. If you have found yourself in this situation, then you are in the right place.
We specialise in secondary data analysis of COA data from clinical trials and outside trial settings. Our analysts are experienced in working with all types of patient-centred and clinical data, study designs, and exploratory and confirmatory statistical techniques. We can help you gain clearer understanding of the story your data tells, and help you present that in ways that communicate core messages to a wide variety of stakeholders via traditional reporting and tailored data visualisation.
We can help you at all stages, whether you are looking for advice, analysis plans, or full analytic services. We help clients make informed decisions, strengthen their evidence base, and confidently navigate the evolving landscape of patient-centred healthcare.
Qualitative and mixed-methods research
What evidence do we need to demonstrate content validity to regulators?
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What symptoms and effects are most important to patients and caregivers?
Do patients understand and interpret our PRO instrument questions appropriately?
Our clinical data isn’t aligned with our PRO data, what’s going on?
We don’t think the EQ-5D is appropriate in our patient population, how can we demonstrate this to HTA?
How can we explore meaningful treatment benefit and estimate meaningful score differences?
Qualitative research is essential to understanding the lived experience of patients and ensuring research is patient-centred.
We use a range of methods to capture the authentic patient experience, including concept elicitation interviews, exit/embedded interviews, cognitive interviews, focus groups, narrative accounts, and mixed methods studies.
These methods help us to understand the patient and caregiver experience in novel ways, ensuring that you measure what matters most, in a meaningful and interpretable way that can be leveraged to support drug development and patient access.
We use qualitative and mixed methods research to inform COA strategy, develop COA instruments, provide patient experience data for licensing and HTA, and inform utility research, economic models and patient preference research.
Our bespoke mixed methods studies have supported decision makers with the interpretation of COA data from clinical trials, and shaped utility strategies.
Health utilities
We didn’t capture utilities in our trials what are our options?
We captured utility data in our trial how can we use that to get estimates for our economic model health states?
Our trial is in rare disease, and we don’t have all the data we need to populate our economic model – what can we do?
We used EQ-5D in our trials, but we don’t see the same benefit in utilities as we do with the other PROs in the trial – why? And what can we do?
HTA don’t like our utility estimates, we have a short timeline to come up with a plan B – can you help?
Capturing health utilities is an essential part of many HTA submissions — and robust utility data can help ensure patient access to life-changing therapies.
The utility approaches we use and develop aim to meet challenges associated with prevalence of disease and hard-to-reach patient groups, as well as time and budget constraints.
We have a long-standing track record supporting clients with their HTA interactions.
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We work with clients to inform trial design, to conduct research alongside trial programs and to complete studies post-licensing. We have particular expertise in rapid de novo studies following initial negative HTA review.
Whether it’s the gold-standard approach, a pragmatic approach or a novel one, we can help identify and action a plan. Trial analysis, vignette studies, mapping studies, development of preference-based measures, our qualitative, analytic and preference study technical skills allow us to address any utility question.
Preference studies
Are patients willing to accept a risk of side effects for a given benefit?
Would a patient prefer our treatment over what’s already available?
Which treatment attributes drive patients’ decisions?
Which preference method should I use with a small sample size?
Is a discrete choice experiment the gold standard?
Why do preferences vary across individuals with the same condition?
Preferences are subjective — but we can help translate the subjectivity into meaningful output using robust scientific methods.
We have expertise across a variety of qualitative and quantitative methods to explore and elicit preferences. Our goal is to identify and develop preference methods that generate preference information tailored to your needs, whether this is to support product design, a regulatory or HTA submission, or value communication to patients and clinicians.
We can show you how different preference information can be used to address your research questions. How much more important is improvement on one symptom over another? How much risk of a side effect would patients tolerate for an improvement in a particular symptom? Is the overall benefit-risk profile of my treatment acceptable from a patient’s perspective? What proportion of patients would accept my product’s profile compared to existing treatments? How would changes in a product characteristics affect its overall acceptability?
If you are looking for answers to any of these questions, we can help you design a bespoke preference study.
Medical writing and dissemination
Manuscript writing and editing
Abstract and poster development
Slide-deck development
Dissemination strategy
White papers
Infographics
To unlock the full potential of research, clear and impactful communication is essential. We offer professional medical writing services designed to present research findings effectively to varied audiences.
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By focusing on clarity and relevance, we help you reach your audience and communicate your value messages, maximising your research’s impact across different stakeholders in the healthcare landscape.
