Global Clinical Trials (GCT), a contract research organization (CRO) serving Eastern Europe and Russia, has expanded its St. Petersburg drug storage facility, a move that will enhance the CRO’s ability to manage trial logistics in that region.
CROs operating in Eastern Europe are not allowed to ship study materials from outside the country directly to research sites. Although most large CROs have their own internal logistics groups to handle these shipments, smaller CROs such as GCT usually rely on outside brokers to import and export trial supplies. These third-party arrangements can cause project delays and increase a study’s costs.
“When we got started, we had to utilize a third party, and oftentimes, within a given project, these people would increase the cost because, as clinical research grew in the area, more opportunities presented themselves, and the costs started to escalate. That’s when we thought, ‘It’s necessary to have our own facility,’” said GCT vice president of business development Richard Leach.
GCT created its own standalone logistics group in 2004, which works across studies and is responsible for all of the CRO’s importation and exportation activities.
The newly expanded 1,100 square-foot space, which opened in November, enables GCT to ship and store more materials by providing more than three times the storage space. The restricted-access facility contains a walk-in refrigerated storage unit, a larger room-temperature storage area, a gate chamber to receive and ship product on pallets, and expanded freezer space. The company will add bar-code tracking and storage capabilities in March 2009.
“We have our own internal brokerage, so we actually have our own import and export capability services, and we have our own storage facility on top of it,” Leach said. “When we make a pickup, we do it ourselves. We go to the airport, we meet with the customs agents, and then we grab the materials and bring it right back to our central facility. We don’t have the middle men.”
The CRO now has the ability and space to support marketed drug products in Russia. “We can actually submit for [marketing] approval and, once approved, support the logistical efforts to bring the product into the country,” Leach explained.
As GCT grows its other offices in the region, Leach expects they’ll open similar storage and logistics facilities in the Ukraine, Romania and Bulgaria based on the needs of their clients and the number of ongoing trials.
Central and Eastern Europe’s clinical trial industry has tripled in the last five years, making it the largest area for global clinical trial initiations outside of North America and Western Europe, according to CenterWatch data.