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Global Logistics and Supply Chain Management

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:

  • All shipments are made on a door to door basis and are closely monitored at every step by our experienced customer service team.
  • Bilcare GCS has considerable experience in handling materials classified as dangerous goods, controlled solutions (bonded or not) across a full range of temperatures from controlled ambient (15oC to 25oC), refrigerated (2oC to 8oC) and frozen (-20oC, -80oC and cryogenic )
  • Global secure delivery and collection directly, and through trusted service partners and fleet of temperature controlled vehicles.
  • GMP compliant temperature controlled facilities providing storage of drugs for trial or distribution, and biological samples.
  • Choice of faster and secure mode of courier transport in airfreight, road and sea-freight.

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.

Supply Chain Management

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

Pre review of materials MSDS and CMDI by Warehiuse personnel before recieving any clnical supply returns.
Shipment of clinical supply return from customer / site/ CRO
Pre review of materials MSDS and CMDI by Warehiuse personnel before recieving any clnical supply returns.
Warehouse personnel shall check the documents for the received consignment.
Checking , Physical Reconciliation and verification of the Clinincal Supply Returns by Warehouse and Quality personnel and documents any discrepancies on the " IP Return Inward Log"
Completion of " IP Return Reconcilitation Form"
Affix " Quarantine (IP Return)" to outside carton
Return for Destruction
Returns for Redistribution
Sent for Destruction as per procedure
Inspection of returns by warehouse and Quality personnel as per required parameters and prepration of "IP Return Inspection Record"
Approval of "IP Return Inspiration Record" and customer clearance for redistribution
Quality personnel affix " Approved" label
Transfer of returns to designated storage location
Redistribution as per customer request to site / CRO
Destruction of Investigation Medical Products carried out by Government Approved Agency
Approval from the sponsor / customer for the destruction of clinical supplies in " Investigation Medicinal Product / Material Destruction Note"
Checking of MSDS for the respective products
Checking of Investigational Medical Products prior to sending for destruction by warehouse personnel and verification by QA against parameters outlined in "Checklist prior to sending investigational medicinal products for destruction" (verification of identification details and quantities etc.)
Label the material with "TO BE DESTROYED" label
Preparation of the Material destruction note and related documents required to be sent along with consignment.
Investigational medicinal products sent to Government Approved Destruction
If sponsor requires QA representative to be present during destruction, then QA/Qc executive accompany the destruction material and will remain present during destruction at Destruction Agency.
Destruction of Investigational Medicinal Products by Destruction Agency as per acceptable method of destruction or specified by customer.
Concerned personnel receive the Certificate of Destruction of material from Destruction Agency.
Review of Certificates for Destruction by Warehouse and QA for required details as per SOP and for any discrepancies and subsequent correction from Destruction Agency.
Filing of all destruction related documents in respective project file. Also copy of Certificate of Destruction is provided to sponsor as per requirment.