CTD/DT 2025 Programme under CT.gov for Chiesi
Chiesi Farmaceutici S.p.A. has assigned Maxer Consulting to implement the 2025 Clinical Trial Disclosure and Data Transparency programme in compliance with the regulations in force in the USA.
The CTD/DT activities require that Maxer upload the results of a series of clinical studies to ClinicalTrials.gov Protocol Registration and Result System according to the regulations in force in the United States (FDAAA 801 and Final Rule).
According to the agreement, Maxer will also anonymize the documents attached to the results (Protocol and Statistical Analysis Plan) for the required studies.
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