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Measuring Patient Outcomes In Your Study

Are you seeking advice on what outcome assessment(s) you should be using in your study? Is an identified COA fit for purpose for your study? Do you need assistance with gaining permissions and support in the use of a COA in your study? If the answer to any of these questions is yes, then please do contact us for advice, and / or assistance.

 

Advice on the Design and Development Of New COAs

The team at InSpired Health Outcomes have designed and developed exceptional Clinical Outcome Assessments (in particular Patient Reported Outcome, or PRO measures) which are robustly tested to exacting standards recognised by regulators and professional societies specific to the sector.

Each COA is suitably tested with appropriate patient populations to demonstrate measurement properties, for example face validity, content validity, test and retest reliability, sensitivity to change. This ensures the developed COA:

Has good measurement properties

Is meaningful to the patient

Measures the concepts or domains, relevant to the target condition and aims of the proposed study

Asks questions about what is important to the patient

Patients' voices are at the heart of each COA we create and manage, from early design, to validation and final application. The team at InSpired Health Outcomes are responsible for developing COAs which are internationally recognised, including by regulatory bodies, such as the FDA or EMA. So, if you seek advice and guidance on the development (or application) of COAs, then please do contact us.

eCOA Review Service

By offering a COA to patients in digital format (eCOA), they will be able to complete the survey conveniently (at a time to suit them and possibly on a device familiar to them), via a laptop, tablet or smartphone.

We offer an eCOA review service which enables our clients to use our managed Clinical Outcome Assessments digitally. We work with all stakeholders (sponsor, eCOA vendor, instrument developer and translation provider) to align requirements.

We first advise on how to migrate a COA into digital format, to ensure its content and therefore measurement properties are not compromised, and we also offer a follow-up review to ensure the migration to digital has been faithful to the original. Our reviews are bespoke to application requirements and can be qualitative or quantitative.

We advise on digital migration of our own suite of COAs, or clients may have their own Clinical Outcome Assessment they wish to use in a digital format.

If you are interested in being supported in your eCOA activities, please get in touch to find out more.

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Other Specialist COA Services

At InSpired Health Outcomes we can offer a broad spectrum of specialist COA related support services. If you have any questions about the design, development, testing or application of COAs then please do contact us. 

Management and licensing of Clinical Outcome Assessments
Management and licensing of Clinical Outcome Assessments

At InSpired Health Outcomes, we have a wealth of experience in the management, promotion, and support in the use of COAs.

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Translation and linguistic validation
Translation and linguistic validation

The InSpired Health Outcomes team and the highly experienced and trusted associates we work with have managed the translation and linguistic validation of thousands of COAs in hundreds of territories and across diverse condition / therapeutic areas.

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