Clinical Outcome Assessments

Gather Data Confidently with IQVIA Clinical Outcome Assessments

IQVIA Clinical Outcome Assessments (COAs) ownership and distribution is dedicated to licensing, distribution, translation, and scientific support for the use of fit-for-purpose questionnaires to confidently measure various healthcare-related outcomes.

Suitable for life sciences companies, academic research institutions, non-profit organizations, and health care systems, our portfolio of COAs consist of psychometrically- and content-valid instruments with large libraries of linguistically validated translations.

Our scientific experts also offer support related to instrument selection and use from study planning and design to data analysis and publication. Permission via a signed license agreement is required for use of all IQVIA distributed COAs.

Licensing and Usage

IQVIA’s licensing process is streamlined to ensure you receive access to the desired COA in a seamless and timely manner. Once you determine which COA and translations that you want to license, please contact us to initiate the license request. A fully executed license agreement is required before the use of any IQVIA COA or scoring algorithm.

IQVIA will work with you to put an agreement in place for licensing available COA translations needed for your research or healthcare use case, develop any new translations, and certify screenshots for electronic COA administration (if applicable). We also offer eCOA Library Licensing to optimize process efficiencies among IQVIA, the eCOA vendor, and an IQVIA preferred translation services provider during the electronic setup of the COA.

A fully executed license agreement is required prior to the use of any IQVIA COA or scoring algorithm (“Licensed Materials”). This includes all use cases including funded and non-funded academic research. See the Pricing Approach section for additional information for academic research users.

IQVIA licenses its COAs on a per use basis (e.g., per study, per registry) for a set duration of time (e.g., per project for the duration of the project or per year with annual renewal for routine care or patient support app use).

IQVIA follows rigorous industry standards for COA translation development (i.e., linguistic validation with cognitive debriefing) and has large libraries of available translations for many of its COAs. If IQVIA does not have one or more translations for your project needs, please provide a list of required translations (country and language for each). We will then provide the cost and timeline estimate for their development. Please note that IQVIA does not permit users to develop new translations on their own, and a fully executed license agreement must be in place prior to IQVIA beginning any work to create new translation(s).

IQVIA offers access to all IQVIA COAs in paper and/or electronic format. For the electronic versions, all United States English translations of our COAs are readily available for administration via IQVIA eCOA, our advanced study build and execution platform that optimizes real-time, direct-from-patient data collection. Click the highlighted link to learn more about IQVIA’s eCOA platform.

IQVIA has set requirements for transitioning its COAs from the source paper format into an electronic format.

The goal of these requirements is to ensure the migration in format has as little impact on the measurement properties of the instrument as possible. This means patients respond to items on paper and electronically in the same way (i.e., the instrument captures the same data regardless of how patients fill it out). During the licensing process, IQVIA will share requirements, which include the user providing screen shots for review and approval for all devices (e.g., tablet, smartphone, computer) on which the COA may be deployed to patients.

IQVIA’s pricing model for research purposes is an instrument fee approach (per translation per project) with license and distribution (labor) fees. IQVIA offers four standard pricing categories to classify the different use cases of the COAs:
for-profit, government, funded academic, and not funded academic research. In the event that a project does not fit into one of our identified categories, IQVIA will review your request and work with you to better understand your planned use of the COA. Pricing is also available for a variety of healthcare use cases. Translation Fees apply when translation work is required, such as for the development of a new linguistically validated translation or translation of COA modifications that IQVIA approved for your project. Screenshot review fees apply when the COA will be administered electronically.

Use of the Licensed Materials is subject to payment of fees quoted in United States Dollars and exclusive of applicable taxes. Fees will be invoiced upon execution of the license agreement.< /p>

Requests to use the COA for academic research and individual clinical practitioner purposes may qualify for a fee waiver or discount.

IQVIA collaborates with eCOA vendors to add IQVIA COAs to vendor eCOA libraries to accelerate eCOA build activities for mutual clients.

Adding IQVIA COAs is an opportunity for eCOA vendors to maintain IQVIA COAs in their platforms for use in future projects without the need to complete the migration step on a per study use basis. Approximate timelines for migrating the paper COA to an electronic platform is 4-5 weeks, so the benefit of adding the COA to the eCOA library is significant in the context of project timelines and efficiencies.

IQVIA requires execution of an eCOA library license agreement before any IQVIA COA can be added to an eCOA library. We offer flexible programs to help vendors maintain both source and translated versions

The Power of IQVIA Scientific Expertise in the Palm of your Hand

IQVIA’s experts in COA selection, development, scoring, analysis and implementation will ensure you select the best COA to meet your study endpoints in the most time-, quality-, and cost-efficient way. We impart consistency and reliability in your project delivery from the time you decide you need a COA to the time you are ready to disseminate your data.

Treatment Satisfaction Questionnaire for Medication (TSQM)

Go-to-measure of its kind that assesses four key dimensions of treatment satisfaction (effectiveness, side effects, convenience, global satisfaction) and is applicable for any therapeutic area, type of treatment or healthcare experience.

COVID Diaries

Weekly and daily diary item banks to measure both short-term and long-term symptoms, patient experiences, and associated impacts of COVID-19 infection and the pandemic more broadly in treatment, vaccine, and epidemiological trials.

Diabetes Quality of Life Clinical Trial Questionnaire (DQLCTQ)

A valid and reliable health-related quality of life questionnaire for use in multinational clinical trials of patients with type I and type II diabetes.

ONYCOE-T Quality of Life Questionnaire Onychomycosis

A valid and reliable questionnaire to measure patient-reported outcomes associated with toenail onychomycosis.

Cronos COAs

We offer full-service support for licensing, distribution, translation, and consulting services on 70+ COAs offered through Cronos Clinical Consulting Services, Inc., an IQVIA business. The available COAs span numerous therapeutic areas and include the PainDETECT (PDQ), Cancer Therapy Satisfaction Questionnaire (CTSQ), International Index of Erectile Function (IIEF), Sexual Health Inventory for Men (SHIM, also known as IIEF-5), and the Overactive Bladder Questionnaire (OAB-Q) family of assessments.

Quality Metric COAs

Quality Metric is now an IQVIA Business. Visit the Quality Metric website to learn more about their complete library of clinical outcome assessments (COAs), including the popular quality of life (QOL) assessments, SF-36v2® and SF-12v2®.

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