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With the FDA Patient-Reported Outcome (PRO) Guidance and EMEA reflection paper having outlined new standards for using PRO endpoints in clinical research, it is essential that any team has experience and regulatory insight to optimize clinical trial programs. At Mapi Values, our outstanding Endpoint Review team and Centre of Excellence for Qualitative Research boasts many years of experience and can make a tangible difference particularly in the early phases of a product life. The following is a list of the areas our Patient-Reported Outcome studies are conducted in:
Patient-Reported Outcome Study Areas
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Symptoms
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Impact of conditions and treatments
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Health-related quality of life
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Satisfaction
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Goal assessment
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Compliance/Adherence
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Work productivity
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Patient preference
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By planning a strong strategy starting with the end in mind, raising any issues and proposing solutions early in the process, we prepare and prompt our clients to have essential discussions with regulatory agencies that will increase the possibility of an ultimately successful PRO submission. Please see below a list of our current service offerings:
PRO Service Offerings
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Strategic consulting on PRO endpoint selection
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Competitor reviews
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Assistance with regulatory encounters with the FDA, EMEA and Asian regulatory bodies
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Gap analysis for optimal measurement strategy
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Development of PRO measures
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Patient-centric qualitative research
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Psychometric validation (classical, item response and Rasch analysis)
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Analysis of PRO endpoints in clinical trials
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Workshops on PRO regulatory issues and PROs in the drug development process
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FDA and EMEA briefing documents
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Incorporation of PRO messages into market access (global value dossiers, formulary submissions and communication plans)
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Our ability to put forward well-researched and documented PRO measures that satisfy the FDA’s requirements is without peer in the marketplace. Our continuous involvement with the FDA has provided us with a unique understanding of the value of a well thought-out and targeted endpoint model followed by a detailed conceptual framework. Our experience of working with the FDA and EMEA is critical to the success of our offering. With a former FDA Endpoint Reviewer working within our highly talented team, we know that the services we offer our clients, along with the ongoing training we provide to our PRO team, puts us in an enviable position of strength.
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MARKET ACCESS OFFERINGS
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