Unblinded Monitoring

By: Y&M, LLC  04/19/2015
Keywords: Drug Development, Clinical Trial, Contract Research Organization

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. 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 specialists provide expert UBM service. 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. Separating unblind tasks, such as UBM, from the blind operation, is the only option to break the conflict and eliminate OAU. Using an INDEPENDENTLY OPERATED UBM service is the BEST WAY to ELIMINATE the risk of operational accidental unblinding at the CRO operational level. UBM is a micro-niche task of double-blind trials. A micro-niche provider, highly specialized in UBM would provide a partner dedicated to the micro-niche task. Y&M is a right fit for the need. Y&M specialists are UBM experts who have many years of clinical trial experience with detailed knowledge of operational accidental unblinding incidents. We are committed to the success of your double-blind clinical trials.

Keywords: Clinical Development, Clinical Monitoring, Clinical Research Associate, Clinical Research Organization, Clinical Trial, Clinical Trial Management, Contract Research Organization, Drug Development, Trial Management

Other products and services from Y&M, LLC

04/19/2015

Unblinded Monitoring

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.