The benefits are apparent. Most of these locales now boast progressive pharmaceutical legislation, a welcoming business environment, low-cost operations, a high availability of skilled and responsive technical personnel, and large and easily accessible pools of naïve populations.
On the flip side, however, these locations can also present overwhelming challenges to bio-practitioners managing delicate biological products, samples and timelines.
Supply Chain Service Center
Fragile infrastructures often give rise to delays that can jeopardize the efficiency of the supply chain from Europe or North America and undermine the timely transfer of crucial supplies and lab specimens. Extreme temperatures fluctuations – whether seasonal or due to a diverse geography – can threaten the integrity of research samples and degrade high-value investigational drugs.
Cumbersome regulatory environments and bureaucratic inexperience can impact import/export processes and upset scheduling. Diverse languages and time zones can impair communication between key personnel on-site and in the home office.
Recognizing the potential pitfalls, many pharmaceutical companies have come to rely on professional service partners like World Courier to facilitate the process. Utilizing its established local presence, experience and “bricks-and-mortar” infrastructure, World Courier now operates its Clinical Trial Supply Chain Services (CTSCS) division – a highly specialized network of company-owned investigational drug storage facilities – in nine strategic locations.
“Our goal is to link the knowledge and experience of our local transport staff in key markets with the specialized skills of pharmacists and quality assurance personnel,” says Carlos Jankowski, World Courier’s Global Executive Director (CTSCS Division), “and to deliver full-service logistical support to pharmaceutical companies conducting global clinical trials.”
Accordingly, each of World Courier’s nine CTSCS facilities has been engineered to provide temperature-controlled validated storage for investigational drugs and trial-related materials in settings ranging from +25oC to -70oC. Each is staffed by full-time licensed pharmacists and trained logistical personnel, and is ISO-certified and GMP-compliant. All materials arriving at or exiting the facility are fully traceable using CTM-STARSM, World Courier’s proprietary softwaremonitoring system which allows customers to view their inventories 24x7 via live password-protected Internet feed.
“We offer a complete one-stop service offering,” says Mr. Jankowski. “From pre-trial coordination with sponsors and site personnel, to specialized training of the bio-staff who handle the transport, to packaging, scheduling and routing, we look for ways to reduce costs and guarantee success before the study begins. Once it is underway, we manage the bulk import of drugs and supplies into the storage facility, assist with regulatory and permit issues, handle intra-country transport to research sites on a same-day or next-day basis, and execute drug destruction requisitions. With our staff available around the clock, our goal is to facilitate the logistics process so that our customers are free to concentrate only on their research.”
World Courier currently maintains CTSCS facilities in Buenos Aires (Argentina), Sao Paulo (Brazil), Santiago (Chile), Bangalore (India),Mexico City (Mexico), Lima (Peru) and Moscow (Russia). In July 2008, the company opened its newest Latin American installation – a 700 square meter facility located in a modern logistics park in Bogotá (Colombia). Three months later the company celebrated the opening of its ninth depot – a 960 square meter depot in Beijing (China). Plans are underway to open similar facilities in other strategic locations in the months ahead.
“In this complex and competitive environment, our customers are continually looking for an ‘edge’ in bringing their international studies in as efficiently and cost-effectively as possible,” says Mr. Jankowski.“Clients routinely find that by using our central climate-controlled storage depots, they can assure product quality, accelerate the regulatory permit process, and significantly reduce customs delays and transportation costs. These shorter lead times and lower costs have brought real value without compromising control of their inventories.”
Pictured here, more than 50 guests from 22 international pharmaceutical companies were invited to tour the facility and celebrate the October 2008 opening of World Courier’s ninth CTSCS investigational drug storage depot in Beijing (China). Like its sister depots, the Beijing facility offers temperature-controlled controlled validated storage for investigational drugs and trial-related materials in settings ranging from +25oC to -70oC, and is staffed around the clock by licensed pharmacists.