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    Clinical Outcome Assessments

    What are Clinical Outcome Assessments (COAs)? What do they measure?

    Learn more about COAs
    Collaborating with questionnaire authors.
    The most trusted distributor of COAs

    700+ exclusive COA distributions on behalf of their copyright owners

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    PROQOLID™: the largest COA database

    7,000+ COAs described in details and accessible in this unique database

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    Services

    Mapi Research Trust provides turnkey solutions for your Clinical Outcome Assessments (COAs) strategies - including COA databases, targeted literature reviews, licensing.

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    COA Databases Patient-Centered Endpoint Intelligence COA Licensing Translation and Linguistic Validation eCOA Licensing COA Repository
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    About ePROVIDE™

    Online access to all our services and COA databases

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    What are eBooklets?

    Find out more about this step-by-step guidance for valid digitization of COAs

  • Author Collaboration
    Author Collaboration

    Our team is dedicated to assisting authors in the daily management of their questionnaires and all derivatives, including translations and electronic versions

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    Reviewing translated assessments.
    Catalog of COAs distributed by Mapi Research Trust

    800+ exclusive distributions of COAs, accessible in ePROVIDE

  • Resources
    Resources

    ACCESS all our resources on COAs and eCOA: webinars, publications, blogs. SUBSCRIBE to receive email updates.

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    New whitepaper

    Digitizing COAs: A streamlined approach to approval

    Developing new PRO instruments.
    New whitepaper

    COAs and copyright: How to mitigate risks of infringement and misuse in clinical research and practice

  • News & Events
    News & Events

    Stay informed with our latest news and check all our upcoming events. SUBSCRIBE to get email updates.

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  • About us
    About us

    Mapi Research Trust is a non-profit organization dedicated to improving patients’ quality of life by facilitating access to Clinical Outcome Assessments(COAs).

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    A global team of multi-disciplinary experts

    Team analyzing PRO data.
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    Collecting & Processing Patient Centered Outcomes information for more than two decades

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  4. IQWIG’s systematic reviews of guidelines

IQWIG’s systematic reviews of guidelines

PROINSIGHT™

The PROINSIGHT database centralizes and summarizes published regulatory recommendations concerning the use of clinical outcome assessments (COAs) (cf. Glossary) to determine treatment benefit and to inform on drug approval and health technology assessment (HTA) review.

In order to help sponsors define their endpoint strategies, Mapi Research Trust launched this database in to inform users about recommendations that are characterized in terms of COAs.

IQWIG

For the Institute for Quality and Efficiency in Healthcare (IQWIG), our team of experts review ‘extracts of the final report’ drafted in English by the IQWIG without time restriction.

Database Content and Information Sources

The focus of the database is exclusively on drug development. Device guidelines are not included.

The scope of PROINSIGHT™ database is in line with the content of PROLABELS™: any COA endpoint mentioned in a guidance is detailed and characterized, whatever the method of measure may be: PRO, ClinRO, ObsRO, PerfO.

Objective measures such as biomarkers and survival are also included in the database if at least one COA is mentioned in the guidance, but they are not accompanied by detailed descriptions of the measures.
Biomarkers include laboratory tests of blood or other body fluids or tissues, or automated measures of biologic or pathologic processes that do not require human judgment or motivation in the generation of a score, e.g., cardiac monitoring, electroencephalograms, imaging tests that are read by electronic algorithms.

The database includes all published documents from the following categories (without time restriction):

FDA Clinical/Antimicrobial Guidance
FDA Clinical/Medical Guidance
EMA Clinical Efficacy and Safety Guidelines
Health Canada Guidelines
IQWIG Systematic Reviews of Guidelines
NICE Clinical Guidelines

 

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