Y&M, LLC
Listed In: Management Consultants
Y&M, LLC is a Micro-Niche provider, highly specialized in Unblinded Monitoring (UBM) for double-blind clinical trials dedicated to avoiding "Operational Accidental Unblinding" risk at CRO level and to ensuring the integrity of blind of double-blind clinical trials. <p> Before contracting a CRO for… Y&M, LLC is a Micro-Niche provider, highly specialized in Unblinded Monitoring (UBM) for double-blind clinical trials dedicated to avoiding "Operational Accidental Unblinding" risk at CRO level and to ensuring the integrity of blind of double-blind clinical trials. <p> Before contracting a CRO for your double-blind clinical trials, you should know a NEW term, <p> "Operational Accidental Unblinding", a serious problem that happens at the CRO operational level that needs to be addressed and prevented. <p> DETERMINING NEED: Double-blind trials in which a CRO is employed for BOTH blind and unblind tasks are at risk for Operational Accidental Unblinding. When study drugs are not blinded at the manufacturer and are instead prepared, packaged and blinded at the participating pharmacy. Unblinded Monitoring (UBM) is needed at the pharmacy. Y&M specialist provide expert UBM service. <p> UNDERSTAND UNBLINDING PROBLEM created at CRO operational level: Contracting a CRO for BOTH blind and unblind tasks of double-blind trials creates a crossover/self-conflict in the operational and management structure at the CRO. This can pose a serious risk of Operational Accidental Unblinding that may cause the failure of the trials. Unblinding incidents at such a high operational level may introduce serious bias into trials and may reduce the subject base for data analysis. The application of SOPs won't fix the problem because the operational and management structure is defective. Read more
Y&M, LLC
834 Kuebler Dr., Ann Arbor, MI
834 Kuebler Dr., Ann Arbor, MI
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