The aim of Mapi Research Trust is to facilitate access to information for all stakeholders in the field of Patient Centered Outcomes, particularly for Clinical Outcome Assessments (COAs). This is why Mapi Research Trust has centralized all its resources and services into the ePROVIDE™ platform.
6,000+COAs described in PROQOLID
2,000+COA label claims listed in PROLABELS
200+Regulatory guidelines centralized in PROINSIGHT
With 30 years of experience in the field of COAs, Mapi Research Trust has developed comprehensive expertise in the strategic and operational management of COAs and derivatives: protection, curation and promotion. Acting on behalf of developers and copyright holders according to their own terms, we adapt our services to the specificities of any profiles who developed, own and/or control one or more COAs.
Making decisions on the selection of an appropriate set of patient endpoints (COAs, diaries, or digital endpoints) requires consideration of many factors including study objective, regulatory requirements, as well as specific trial design factors and often becomes a daunting task for sponsors. Our team of experts performs a targeted but comprehensive landscape analysis.
For any Clinical Outcome Assessments, distributed by Mapi Research Trust or not, our team acts as a single point of contact for study teams to secure all licensing agreements, reducing the burden for sponsors. Our COA licensing services include a complete gap analysis of available versions and translations, investigation of the requirements of the COAs to be used for the study (conditions of use, electronic implementation, linguistic validation, …), scoring guides, license agreements, etc.
As COAs are scientific material undergoing rigorous validation of their measurement properties, their translations must follow an equally rigorous process to ensure they are understood the same way no matter the language used. Linguistic validation ensures that equivalence is addressed during the development of translations, meaning that the integrity of the original COA’s psychometric measurement properties are maintained. This will allow data to be safely compared across countries and languages.
eCOA is the digitization of paper versions of Clinical Outcome Assessments (COAs), enabling electronic capture of data. Prior to going live, the process of digitization and eCOA implementation must be robustly tested to validate the integrity of measurement properties. To ensure equivalence between the eCOA and the original COA version, and to ultimately secure the validity of the eCOA measurement properties, Mapi Research Trust has developed a set of complementary services dedicated to eCOA implementation.
Are you leveraging knowledge from past COA successes? If well documented, implementing lessons learned from past experience will increase efficiency. Accessible in your personal space under ePROVIDE™, your company’s COA repository stores all key information on the COAs you have used in your clinical studies. Whether distributed by Mapi Research Trust or by another vendor, developed by the sponsor or in the public domain, any COA can be saved in your COA Repository.