Two New RBM Papers from TransCelerate

From One, Come Two
If you follow the TransCelerate RBM initiative closely, since its July update you’ve been eagerly anticipating the availability of the paper entitled “TransCelerate BioPharma: Central Monitoring Model and Technology Specification Proposals to Enable Risk-Based Monitoring Adoption.”  Now that the paper is publically available, your patience has been rewarded twice.  TransCelerate chose to divide the single document into two, one focusing on central monitoring, the other focusing on RBM-enabling technologies.  Publishing separate documents was a good decision.  As you’ll see, each topic is certainly rich enough to warrant individual treatment.

Anatomy of a Vendor Qualification Program

Pharmaceutical companies are only as compliant as their vendors.  In a contract manufacturing arrangement, the manufacturer is held responsible for any cGMP deficiencies; however, you, as the sponsor or CRO, would be held responsible for your lack of vendor oversight.  Moreover, if your manufacturer fails to meet regulatory standards, you could lose millions in profits and patent exclusivity, damage your company’s reputation, and even jeopardize your entire business.

And that’s why a vendor qualification program is so critical.