DMLogic Delivers Process Design Software Tools to Support Clinical Trials

One pharmaceutical company shunned the outsourcing option, referring to oversee its own trials. The company contacted the consultants at DMLogic to develop a system for managing the entire clinical operation, a system that would integrate trial shipments into its regular trade operation.

The exacting requirements of pharmaceutical manufacturing and shipping demand complex product tracking coupled with zero tolerance for error. Expiration dates, temperature sensitivity and special handling are just a few of the constraints inherent in pharmaceutical logistics.

In their normal course of operations, pharmaceutical manufacturers usually ship their products to a few large distributors and retailers, with shipment visibility through the supply chain. But drugs in use for a clinical trials require a very different way of operating.

Though the pharmaceutical supply chain is, by its nature, complex, nothing matches the level of sophistication, detail and accuracy needed to ship the drugs used in clinical trials. An overarching challenge is how to track the clinical trial drugs with pinpoint accuracy while eliminating any identifying characteristics. Research protocol usually dictates a doubleblind experimental design, where neither the person administering the drug nor the person receiving the drug knows dosages or which product contains the active ingredients.