Blog
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The Power of Patient-Reported Outcomes in Labeling Claims
This blog details how Patient Reported Outcomes (PROs) are gaining prominence as a way for pharmaceutical companies to support drug labeling claims.
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Quality-Adjusted Life Years (QALY) in Cost-Effectiveness Analysis
This blog presents the concept of Quality-Adjusted Life Years (QALY), a valuable tool to evaluate the cost-effectiveness of medical interventions.
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eCOA digitisation: how to optimise licensing & screenshot review for faster turnaround times
In this blog, Mapi Research Trust presents solutions to help streamline the eCOA licensing and screenshot review process, with the goal of leading to faster turnaround times.
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PROs: A Critical Component in the Development of Patient-Centered Treatments
This blog presents Patient-Reported Outcomes, the different reasons why they should be considered in clinical trials, and the challenges and considerations when implementing PROs.
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COAs 101: Going Back to Basics
This blog gives insights on Clinical Outcome Assessments (COAs) and how they can enhance your study's impact, improve patient outcomes and more.
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FDA & EMA COA qualification programs
In this blog, Mapi Research Trust presents regulators’ opinions which can facilitate COA selection in drug development.
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eCOA implementation: how to ensure equivalency with the COA paper version
This blog presents the rigorous process to ensure the equivalency between electronic and paper versions, and the validity of the data electronically collected, based on the eCOA best practices.
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Clinical Outcome Assessments' copyright
This blog gives you keys to understand the copyright, how to obtain permission to use a COA, and what rights are granted with a license to use a COA.
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How to successfully prepare the licensing of Clinical Outcome Assessments
In this blog post we detail key steps of COA licensing, risks and common pitfalls, as well as mitigation plan to ensure streamlined COA licensing.
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Best practices to keep eCOA implementation off the critical path of clinical trial startup.
This blog post details eCOA implementation best practices: key steps and solutions to keep eCOA off the critical path of clinical trial startup.
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Patient-Reported Outcomes as Endpoints in Oncology Labeling Claims: An FDA/EMA Perspective
This blog post details the differences in approaches between FDA and EMA that are critical for sponsors to develop PRO strategies for drug labeling claims.