Clinical Outcomes Assessment (COA) Licensing Mapi is the leading provider of COA licensing and information services for academic research and the pharmaceutical industry. As the curator of information on over 3300 COAs and managers of PROQOLID, the largest single repository of COAs itemizing information on nearly 1000 instruments, Mapi provides access to COA documentation and understands the unique licensing requirements for thousands of questionnaires and their scoring materials. Additionally, Mapi directly manages over 130 COAs on behalf of developers through our Distribution Service. Our services support all aspects of COA licensing requirements from information on COAs, advice for HEOR, licensing, and availability of Linguistically Validated versions. Included services Mapi obtains permission to access and use COAs and/or their translations, through negotiating the necessary license agreements with appropriate parties when applicable. This process may include permission to translate / modify / adapt / use in e-application if needed. • Obtaining permission to legally access / use COAs and their translations • Gaining permission to translate / modify / adapt into digital applications • Collecting information on conditions of use • Providing recommendations on translations and linguistic validation work that may be needed • Ensuring compliance with copyright laws 5 STEPS to COA Licensing STEP 1 Agreement MAPI COA License Services Mapi has experience with many types of licensing authorities, including but not limited to: An agreement stipulating the terms and conditions of this service enabling Mapi to negotiate and manage the complete licensing • Hundreds of individual developers of instruments process on behalf of our clients. • Pharmaceutical companies including: STEP 2 Study details • Journal publishers including: expected patients, # of administrations, mode of administration for each instrument, etc.) is completed to support the licensing process to • Test publishers: determine the nature and scope of the licenses required. Mapi completes an in-depth search on the requested instruments to • Academic groups or organizations including: obtain information on the conditions of access and use, as well as any further information needed on the instrument. This can include the availability of language versions and measure-specific information. • Specialized companies such as QualityMetric Approval Upon approval of the conditions of use (legal and financial), Mapi will proceed with obtaining the relevant authorizations. Permission to use We obtain the license agreements and collaborate with legal representatives to finalize the contracts and related invoices. Copies of instruments and other derivatives (which may include ° ° ° ° ° EuroQoL Group Movement Disorders Society Royal College of Psychiatrists American Urology Association WHO • Universities and Institutions including: STEP 5 ° GL Assessment ° Testzentrale ° ECPA Information search STEP 4 ° BMJ ° Elsevier ° WPS A template which includes study information (e.g., study title, # of STEP 3 ° Pfizer ° GSK ° ° ° ° ° Stanford University UCLA McMaster University Johns Hopkins University University of South Florida Additionally, Mapi has experience in handling licensing for the following gold-standard instruments: translations, translation certificates, etc.) can be provided through a • SF-36 • EQ-5D variety of delivery methods including email, FTP, and custom portal. • HAM-D • KDQOL • FACIT Instruments • MSIS-29 • FLIE For more information on Mapi’s license management services, visit mapigroup.com or email [email protected]
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