A global specialty pharmaceutical company opted to outsource Randomization and Trial Supply Management (RTSM) services to Medidata Solutions for a blinded study conducted by a global, full-service contract research organization (CRO). Recognizing the necessity for a Clinical Supply Manager, the team sought to facilitate intentional unblindings, wherein the Principal Investigator (PI) or designee requests the revelation of the assigned investigational product (IP) to the patient. Intentional unblindings typically occur in cases where the patient experiences an adverse or serious adverse event, necessitating further evaluation of the IP's relationship.
Additionally, the team identified a requirement for managing unintentional unblindings, instances where the IP is released without prior consent. The unblindings are seamlessly executed within the Medidata Rave RTSM system, ensuring the confidentiality of blinded study data integrity. Faced with the absence of a dedicated resource for post go-live activities in RTSM and unblinding management, both the Sponsor and CRO engaged Medidata to provide Live Study Management (LSM) services. This service, facilitated by a team of RTSM experts, offers flexible and scalable unblinded support to meet the specific needs of the blinded randomization and trial supply management requirements.