At Bilcare GCS, our commitment is to deliver end-to-end solutions that offer support through the entire clinical trial life cycle. Bilcare GCS provides reliable and credible long term clinical trial supplies management across the globe, through its network of depots and carefully selected partners.
Some of the highlights of Bilcare GCS's logistics and supply chain management include:
Bilcare GCS logistics service is associated with a 24×7 customer portal for inventory and delivery status with advance SAP inventory management system. Our supply strategies are committed to overarching simulation, forecasting and cost-management for entire process.
Apart from logistics and supply chain management, Bilcare GCS also has a very effective returns and destruction mechanism in place. We have a very stringent policy regarding returns and destruction of CTMs. The process is well defined with checkpoints at every stage, to ensure proper return and destruction of CTMs.
Imagine cold chain breakage for a critical life saving drug clinical trial shipment – which is often a fact in given logistics, infrastructure scenario in developing world countries .The World Health Organization reports that the Effective Vaccine Management assessment (carried out in more than 70 countries between 2010 and 2012) found that only 29% of countries met its minimum recommended standards for temperature control.
Underdeveloped infrastructure in low-resource settings often results in an unreliable power supply with sporadic and frequent power cuts. This situation leads to an ineffective cold chain with greater reliance on human supervision and regulation and can result in inadequate and ad-hoc approaches to resolving cold chain problems.
Refrigeration often goes out of service and logistics going through other vagaries during transit where dry ice/gel pack becomes either ineffective or caught up in its own limitation of life or slightest change in temperature and humidity adversely affecting the drug.
Today, there is no real time check to ensure potency or stability of the drug from dispatch to receiving end in real term sense. Failure of multibillion drug due to lack of efficacy measurement often goes to sponsor or innovator Co. without actually knowing the real reason- cold chain breakage during transit.
WHO estimates that about $200 million US dollars is needed per year to address the cold chain needs in low-income countries. Is it worth spending such amount only to land up in efficacy failure due flaw in current system of cold chain management.
It is estimated around 30 % of vaccines lose stability due to cold chain breakage and other reason during transit. Imagine such situation for a life saving Meningitis vaccines going to remotest part of Africa and Sub Saharan region.
With trials becoming more complex, regulatory scrutiny increasing and increasing temperature sensitivity of compounds the supply chain logistics has become a critical component of any clinical trial.
Bilcare GCS in collaboration with Godrej is bringing a unique mini refrigeration technique which will end woes/zero chance of cold chain breakage and ensure complete efficacy of the drug. The system is fool proof, backed with long life battery generated refrigeration with best possible Cold Chain Uptime and not depended on any extrinsic factor causing loss during entire journey of cold chain management, from packaging to delivery. Giving flow chart as below not recommended