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 the blind of double-blind clinical trials.
Before contracting a CRO for your double-blind clinical trials, you should know a NEW term, "Operational Accidental Unblinding" a serious problem that happens at the CRO operational level that needs to be addressed and prevented.
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. UBM is needed at the pharmacy. Y&M specialist provide expert UBM service.
UNDERSTAND UNBLINDING PROBLEM created at CRO operational level: Contracting a CRO for BOTH of the blind and unblind tasks of double-blind trials creates a crossover/self-conflict structure at the CRO operational level. 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 to trials and may seriously reduce the subject base for data analysis. The application of SOPs won't fix the problem because the operating structure is defective.
ELIMINATE THE RISK: Using an INDEPENDENTLY OPERATED UBM service is the BEST WAY to ELIMINATE the risk of operational accidental unblinding risk at the CRO operational level.
MICRO-NICHE PROVIDER FOR YOUR MICRO-NICHE TASK: The UBM is a micro-niche task of double-blind trials. When separating UBM from the crossover/self-conflict operation structure, you don't want to throw your small fish into another big pond because it will not catch any dedicated attention. A micro-niche provider, highly specialized in UBM would provide a partner dedicated to the micro-niche task.
UBM EXPERT: Y&M specialists are UBM specialists are UBM experts who have many years of research experience with detailed knowledge of operational accidental unblinded incidents. We are committed to the success of your double-blind clinical trials.
EASY CONTRACT: Our transparent fixed unit-price approach will make your contracting much easier.