Case Studies

Product Recall

Situation

Caligor was alerted by manufacturer not to proceed with further shipments of a popular chemotherapy medication that already was in place at many clinical trial sites around the world. The early warning reflected our trusted relationship with the customer and enabled us to begin preliminary planning for the anticipated recall.

Actions

• SOP documentation proved invaluable in handling the recall.
  

• The team relocated the recall center to accommodate the massive quantity of product that had to be returned.
  

Result

• By virtue of our excellent relationship with another manufacturer, we were able to replace the recalled stock with a generic equivalent, ensuring minimal trial disruption.
  

Document and Tracking

Situation

Caligor shipped a large order for ancillaries to a customer, with the understanding that back-ordered syringes would be sent separately when they arrived at our warehouse two weeks later.

Actions

• Upon notification from the customer several months later that the shipment of syringes had not arrived, Caligor was able to provide detailed documentation, including: packing information; photos of the pallet, wrapped and ready for collection; collection notes showing when the shipment left Caligor’s warehouse and arrived at the customer’s site; a document bearing signature of the person who received the shipment.
  

Result

• Caligor’s careful documentation earned the loyalty of the customer, who ultimately was able to locate the pallet in its warehouse several days later.
  

Temperature-Sensitive Vaccines

Caligor Rx was engaged to coordinate and manage a logistically complex trial involving two vaccines that required cold-chain handling.  The customer had to deliver a box containing each vaccine to 45 unique clinical study sites, each of which had its own schedule.

Caligor Rx stored the entire shipment of vaccines at our cold-chain facility.  After confirming the transport temperature with each site, we then delivered the vaccines to the sites as they were activated and notified the sites regarding shipment status and data logging.  In addition, we produced reports detailing which sites had received vaccines, monitored remaining inventory levels, tracked and documented temperature excursions that occurred at the sites and responded to questions for our pharmacist from site personnel.

Special Manufacture

Caligor Rx recently demonstrated the effectiveness of its close relationship with pharmaceutical manufacturers. A customer running a comparator trial needed a large quantity of single-batch drug from EU, and needed it in a nearly impossible timeframe.  Of the three companies producing the product, only one had the capacity and capability to do so within the required window – but only as a special manufacturing run.

We negotiated with the manufacturer during Christmas and New Year’s and worked closely with the customer’s clinical team to determine the best way to meet the supply needs of the various sites.  Our outstanding relationship with the manufacturer enabled us to procure the product two months ahead of schedule at  substantial cost savings, and to maintain the customer’s anonymity throughout the process. 

Unlicensed Medicine

On December 23, Caligor Rx received an urgent phone call from the Centers for Disease Control and Prevention (CDC). A patient who had posthumously donated several organs had been infected with a rare disease. Now the recipients had become infected with the disease, and their health was deteriorating rapidly.

The medication needed to save the lives of the recipients had not been approved in the US, and was available only from the EU.  Further complicating matters, the medication contained animal-derived ingredients, posing additional importation hurdles, since all products with animal-derived ingredients must first be cleared through the US Department of Agriculture (USDA) to ensure the safety of those ingredients.

Our challenge was to procure the medication from overseas immediately; otherwise, the organ recipients would not survive the Christmas holiday.  Though businesses in the EU were closed, we were able to contact our overseas supplier and have the product shipped by courier, leaving us less than a day to clear all regulatory hurdles.

Through our contacts at the US Food and Drug Administration and the CDC, we obtained an emergency treatment IND for the patients. We then turned our focus to the USDA, where we also had well-established relationships. Our reputation and expertise enabled Caligor to obtain a special one-time permit to allow the medication into the US. We prepared all the necessary documentation and had the paperwork waiting when the product arrived at customs. Once the product was cleared late in the evening, a Caligor executive hand-delivered the package to a courier, ensuring that the medicine arrived at the hospital in time to save the patients’ lives.

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