It is well known that clinical trials are getting larger and more complex than ever. Nowadays drug makers need to reduce their research and development costs, time-to-market requirements and to reach far away markets to remain competitive. As such, a key factor in conducting successful studies is the efficient management of clinical supplies with precise planning and coordination of activities. Otherwise, huge bottlenecks could cause delays in shipping, trial completion and in getting new drugs to the market. They could also cause patient disqualification, damage to investigator relationships, and money loss, which could potentially jeopardize the entire clinical study.
The first thing that should be done to avoid these problems is to measure the existing supply chain to identify weaknesses and sub optimized processes, build a sequence of activities and set a way to measure progress. It is also important to determine what the business priorities are. A good way to do this is to use technology, which has proven to benefit the healthcare industry in general and the supply chain in particular. However, it is important to have a solid foundation first to ensure maximum impact of such technology.
If used at the right time, an effective IT infrastructure can help drug makers accomplish their goals, such as a timely supply of drugs to sites, optimize costs, compliance with regulations, accuracy and good manufacturing practices.
The benefits
One technological solution is SAP. SAP applications allow sponsors to manage production operations, materials, personnel, documents and finances, as well as to strengthen collaboration with suppliers and customers in a faster, more accurate and effective way. In the pharmaceutical industry, SAP technology can be used to analyze big data to drive personalized medicine and manage development, collaboration and R&D costs; synchronize demand and supply, optimize inventories, and help trace drugs and devices; simplify sourcing and procurement and optimize supplier performance, as well as align internal and external manufacturing.
All of this can significantly help enhance and improve the processes for forecasting, planning, manufacturing and distribution of clinical trial supplies and thus minimize challenges related to end-to-end supply chain process. A more efficient supply chain will of course result in shortened study times, faster market introductions, reduced R&D costs and increased market share and customer loyalty.
Supply chain automation through SAP tools allows all products, kits and components, to arrive in time for dispensation, and to replace stocked out products as quickly as possible without having large inventories. Manufacturing and retail companies, such as Wall Mart, IBM and Microsoft, were the first ones to adopt this solution with excellent results, but these technologies can now benefit the clinical trial industry as well.
Even though this system is not the entire solution, it does offer a competitive advantage in the market. Pharmaceutical and biotechnology companies should closely collaborate with SAP developers in the creation of industry specific solutions that address unique challenges within the clinical supply chain.
