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Speed | Innovation | HappinessSpeed | Innovation | Happiness
Global
Clinical
Supplies
Comparator Sourcing Capabilities
Speed | Innovation | Happiness
The comparator procurement process is becoming tedious and time consuming due to:
• Increasing complexity of clinical trials
• Lack of meticulous planning
• Stringent Regulatory requirements
• Counterfeit dangers
• Over/under ordering
• Sponsor’s reservation to disclose Trial Information resulting in challenges in procuring
Innovator Drugs
Business Challenges
Not gaining reliable access to comparator can delay the trials
or lead to its early termination making it critical
Speed | Innovation | Happiness
Bilcare GCS – Comparator Procurement Services
• Confidentially access drugs worldwide for global clinical trials
• Provide Regulatory compliance and necessary product documentation
• Capability to provide large volume of drugs in multiple or single lot batches
with long expiration dates
• Provide drug related documents like COA, MSDS as applicable
• Procure authentic products and full batch traceability
• Guidance to Sponsors to enable Proactive Planning for sustainable &
significant cost savings
• Providing Cost Effective Cold Chain Logistics
Complete and a sound understanding of all critical issues
involved in sourcing comparators for Global Clinical Trials
Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited
Bilcare GCS – Comparator Drug Procurement
Expertise in procurement and logistics management of critical drugs across various countries
Americas
• US
• Mexico
• Brazil
EU
• UK
• Germany
• Italy
• Switzerland
• France
• Polland
• Czech
Asia Pacific
• India
• China
• South Korea
• Philippines
• Singapore
• Sri Lanka
• Thailand
• Taiwan
• Japan
• Australia
MEA
• South Africa
• Israel
• Turkey
• UAE
Speed | Innovation | Happiness
Bilcare GCS - Project Handling expertise
• Succefully handled procurement of vaccines, medicines for ulcerative colitis,
cancer, Diabetes, Heart disease etc and Hormonal contraceptives
• Completed Procurement of Vaccines of Phase III trial for one of a Big Pharma
company. (The procurement was done directly from Vaccine Manufacturer & was also a
cost competitive proposal for our client)
• Handled numerous small quantity (RLD requirements) of various drugs for
clinical trial
• Drug in single and multiple batches
• Drugs requiring controlled temperatures
Speed | Innovation | Happiness
Expertise in managing cost of supplies
• Sourcing products through Wholesalers and Direct from Manufacturers
(most competitive options for clients)
• Repeat orders to the Wholesalers and Manufacturers further add to the
price benefits
• Preferably procure the products from the country of origin (save on time)
• Capability to provide Alternate product if required by our client (needs a
detailed description of the comparator such as its name and strength of
active ingredient)
Bilcare has extensive global references, indicators, and expertise
that provide us with valuable insight during comparator inquiries
and purchases to have a better price advantage and helps in negotiations
Speed | Innovation | Happiness
Costing Model
• Costs of material Sourcing/procurementProduct Cost
• Provide complete Project Management (coordinate supplies, compile resources, prepare
instructions, and perform other necessary functions to enable the successful completion
of this project) throughout the entire duration.
Project Management
• This is inclusive of but not limited to Storage, packaging, domestic
Transportation/warehousing (if applicable), shipping documentation preparation and
other overseas transportation related cost etc.
Logistics & Distribution Cost
• This includes cost of import & export licenses obtained from respective regulatory agencyRegulatory Licensing Cost
• Custom Clearances & Duties (as applicable) and Transit InsuranceDocumentation
• As applicable in various countriesValue Added Tax
Speed | Innovation | Happiness
Comparator drug procurement – Activity Flow
For any enquiry following activities are done along with lead time required for each
Availability Check
Initial check of comparator drug
availability in designated country (lead
time should be counted upon receiving
availability inquiry to submission of
availability results to clients)
Maximum three working days
Quotation
Provide quotation and expected sourcing
lead time to clients
Bilcare can meet a 48-hour turn around
time in providing a quotation for the
Comparator services. Complex procurement orders may
take longer depending on the nature of the request
Material sourcing and
shipping preparation
Source comparator drug, prepare related
external packaging/shipping documents,
arrange export and shipping etc (lead
time should be counted upon order
confirmation to comparator drug
shipment ready for shipping)
Lead time for certain comparator products can vary as they
depend on which world market the product is being
sourced and the type of product (i.e. Controlled drugs etc,
Import/export regulatory compliance). Bilcare coordinates
extensively with all vendors to ensure that we obtain the
comparator products requested within the most efficient and
effective amount of time. Till now, Bilcare has fulfilled the
delivery requirement in max 40 days from date of order
confirmation.
Speed | Innovation | Happiness
Regulatory Support
Well versed with handling requirements to obtain Import/Export
license required for importing/exporting of Comparator drugs
from a particular country
Expertise in handling custom clearances
Well organized in Providing required documents for EXIM and
Customs
Speed | Innovation | Happiness
Bilcare GCS - Depot Network
Expertise in handling temperature controlled shipments, monitor the temperature
during its storage and transportation to required destination
Asia – Pacific
Pune, India
Depot Partners
Australia & New Zealand
China
Japan
Malaysia
Philippines
Sri Lanka
Singapore
South Korea
Taiwan
Thailand
Afro- Gulf
Depot Partners
Malawi
South Africa
Israel
EU
Depot Partners
France
Germany
Netherlands
Turkey
Russia
Ukraine
UK
Americas
Depot Partners
Argentina
Brazil
Mexico
USA
Speed | Innovation | Happiness
Summary
Bilcare GCS
Comparator
Procurement
Solutions
Expert
Knowledge
Market
Intelligence
Regulatory
Compliance
Documentation
Secure Supply
Chain
Quality
Assurance
Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited
Comparator Procurement – Business Relationship
Asia EU Americas MEA
7 14 10 5
Asia EU Americas
9 2 9
Vendor Relationship
Sponsors/ CROs
Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited
COMPARATOR PROCUREMENT CASE STUDIES
Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited
Hot Jalapenos
Introduction:
A customer, based in US, providing Oncology patients with important and innovative therapeutic products
required Oncology Product for their Clinical Trial. They were finding it difficult to procure the required
product in the market. The customer engaged Bilcare GCS services to overcome their limitations and fulfill
their requirement.
Challenge:
The customer wanted substantial quantity of Vials of the drug which were in short supply globally. Bilcare
faced teething challenges in the procurement though the customer had given a mandate to source the
product globally.
Outcome:
Owing to the exhaustive supply network, Bilcare convincingly procured the required drug from one of our
suppliers in Mexico, South America. Bilcare successfully executed the project. The supplies were
delivered before time along with the CoA and other necessary documents in place.
Benefit:
Owing to the extensive supply network of Bilcare, the client was able to secure their supplies to meet
their stringent timelines.
At Bilcare, we are very proud of our strong supplier network, which we consider one of our great strengths.
Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited
Introduction:
A customer, based in US required an Innovator product for their RLD (Reference Listed Drug) need. They
wanted to procure the drug from Japan and subsequently bring it to India. The customer engaged Bilcare
GCS services to overcome this limitation.
Challenge:
Fetching the drug in Japan and exporting thereafter was an uphill task due to stringent control of the
innovator companies on all the drugs in Japan. The customer was finding this challenging given the
Language barrier and the CT project timelines.
Outcome:
Bilcare through its strong strategic partners in Japan, overcame this challenge and procured the required
drug quantities. Owing to the vast experience in drug procurement and having handled various projects in
various countries, Bilcare was able to explain and convince the innovator companies of the nature of the
end-use of the required products.
Benefit:
A win-win situation wherein the customer was able to find a dependable partner and Bilcare was able to
add another trustworthy and a long-lasting business relationship to its account.
At Bilcare, we are very proud of our industry-wide experience, which we consider one of our great strengths.
In the land of the Rising Sun
Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited
Introduction:
Company headquartered in France with their subsidiary in Singapore required Cardiovascular Drugs to be
procured from Philippines for CT purposes in Philippines. The customer engaged Bilcare GCS services for
this special requirement.
Challenge:
The company had a threat of counterfeit drugs and were finding solutions to procure their required
authentic quantity from a trustworthy partner. On the other hand, their was a pricing issue that the
company was facing as the other alternatives were very costly and were threatening the sponsor
budgets. The customer was finding this challenging and hence approached Bilcare GCS for authentic and
cost effective solution.
Outcome:
Bilcare through its vast experience in pharmaceutical packaging and having key business relationships
locally ensured uninterrupted supply of study products such that timelines as well as budgetary
requirements are not exceeded.
Benefit:
Just in time services ensured that the client was able to conduct the Clinical Trial smoothly
At Bilcare, we are very proud of our industry-wide experience, which we consider one of our great strengths.
The Philippino Challenge
Speed | Innovation | Happiness
Thank you
www.bilcareGCS.com
“Experience Bilcare - Experience World Class Services”
Dr. Abhigyan Upadhyay, Vice President- Business Operations
abhigyan.upadhyay@bilcare.com

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Bilcare GCS Comparator Procurement

  • 1. Speed | Innovation | HappinessSpeed | Innovation | Happiness Global Clinical Supplies Comparator Sourcing Capabilities
  • 2. Speed | Innovation | Happiness The comparator procurement process is becoming tedious and time consuming due to: • Increasing complexity of clinical trials • Lack of meticulous planning • Stringent Regulatory requirements • Counterfeit dangers • Over/under ordering • Sponsor’s reservation to disclose Trial Information resulting in challenges in procuring Innovator Drugs Business Challenges Not gaining reliable access to comparator can delay the trials or lead to its early termination making it critical
  • 3. Speed | Innovation | Happiness Bilcare GCS – Comparator Procurement Services • Confidentially access drugs worldwide for global clinical trials • Provide Regulatory compliance and necessary product documentation • Capability to provide large volume of drugs in multiple or single lot batches with long expiration dates • Provide drug related documents like COA, MSDS as applicable • Procure authentic products and full batch traceability • Guidance to Sponsors to enable Proactive Planning for sustainable & significant cost savings • Providing Cost Effective Cold Chain Logistics Complete and a sound understanding of all critical issues involved in sourcing comparators for Global Clinical Trials
  • 4. Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited Bilcare GCS – Comparator Drug Procurement Expertise in procurement and logistics management of critical drugs across various countries Americas • US • Mexico • Brazil EU • UK • Germany • Italy • Switzerland • France • Polland • Czech Asia Pacific • India • China • South Korea • Philippines • Singapore • Sri Lanka • Thailand • Taiwan • Japan • Australia MEA • South Africa • Israel • Turkey • UAE
  • 5. Speed | Innovation | Happiness Bilcare GCS - Project Handling expertise • Succefully handled procurement of vaccines, medicines for ulcerative colitis, cancer, Diabetes, Heart disease etc and Hormonal contraceptives • Completed Procurement of Vaccines of Phase III trial for one of a Big Pharma company. (The procurement was done directly from Vaccine Manufacturer & was also a cost competitive proposal for our client) • Handled numerous small quantity (RLD requirements) of various drugs for clinical trial • Drug in single and multiple batches • Drugs requiring controlled temperatures
  • 6. Speed | Innovation | Happiness Expertise in managing cost of supplies • Sourcing products through Wholesalers and Direct from Manufacturers (most competitive options for clients) • Repeat orders to the Wholesalers and Manufacturers further add to the price benefits • Preferably procure the products from the country of origin (save on time) • Capability to provide Alternate product if required by our client (needs a detailed description of the comparator such as its name and strength of active ingredient) Bilcare has extensive global references, indicators, and expertise that provide us with valuable insight during comparator inquiries and purchases to have a better price advantage and helps in negotiations
  • 7. Speed | Innovation | Happiness Costing Model • Costs of material Sourcing/procurementProduct Cost • Provide complete Project Management (coordinate supplies, compile resources, prepare instructions, and perform other necessary functions to enable the successful completion of this project) throughout the entire duration. Project Management • This is inclusive of but not limited to Storage, packaging, domestic Transportation/warehousing (if applicable), shipping documentation preparation and other overseas transportation related cost etc. Logistics & Distribution Cost • This includes cost of import & export licenses obtained from respective regulatory agencyRegulatory Licensing Cost • Custom Clearances & Duties (as applicable) and Transit InsuranceDocumentation • As applicable in various countriesValue Added Tax
  • 8. Speed | Innovation | Happiness Comparator drug procurement – Activity Flow For any enquiry following activities are done along with lead time required for each Availability Check Initial check of comparator drug availability in designated country (lead time should be counted upon receiving availability inquiry to submission of availability results to clients) Maximum three working days Quotation Provide quotation and expected sourcing lead time to clients Bilcare can meet a 48-hour turn around time in providing a quotation for the Comparator services. Complex procurement orders may take longer depending on the nature of the request Material sourcing and shipping preparation Source comparator drug, prepare related external packaging/shipping documents, arrange export and shipping etc (lead time should be counted upon order confirmation to comparator drug shipment ready for shipping) Lead time for certain comparator products can vary as they depend on which world market the product is being sourced and the type of product (i.e. Controlled drugs etc, Import/export regulatory compliance). Bilcare coordinates extensively with all vendors to ensure that we obtain the comparator products requested within the most efficient and effective amount of time. Till now, Bilcare has fulfilled the delivery requirement in max 40 days from date of order confirmation.
  • 9. Speed | Innovation | Happiness Regulatory Support Well versed with handling requirements to obtain Import/Export license required for importing/exporting of Comparator drugs from a particular country Expertise in handling custom clearances Well organized in Providing required documents for EXIM and Customs
  • 10. Speed | Innovation | Happiness Bilcare GCS - Depot Network Expertise in handling temperature controlled shipments, monitor the temperature during its storage and transportation to required destination Asia – Pacific Pune, India Depot Partners Australia & New Zealand China Japan Malaysia Philippines Sri Lanka Singapore South Korea Taiwan Thailand Afro- Gulf Depot Partners Malawi South Africa Israel EU Depot Partners France Germany Netherlands Turkey Russia Ukraine UK Americas Depot Partners Argentina Brazil Mexico USA
  • 11. Speed | Innovation | Happiness Summary Bilcare GCS Comparator Procurement Solutions Expert Knowledge Market Intelligence Regulatory Compliance Documentation Secure Supply Chain Quality Assurance
  • 12. Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited Comparator Procurement – Business Relationship Asia EU Americas MEA 7 14 10 5 Asia EU Americas 9 2 9 Vendor Relationship Sponsors/ CROs
  • 13. Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited COMPARATOR PROCUREMENT CASE STUDIES
  • 14. Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited Hot Jalapenos Introduction: A customer, based in US, providing Oncology patients with important and innovative therapeutic products required Oncology Product for their Clinical Trial. They were finding it difficult to procure the required product in the market. The customer engaged Bilcare GCS services to overcome their limitations and fulfill their requirement. Challenge: The customer wanted substantial quantity of Vials of the drug which were in short supply globally. Bilcare faced teething challenges in the procurement though the customer had given a mandate to source the product globally. Outcome: Owing to the exhaustive supply network, Bilcare convincingly procured the required drug from one of our suppliers in Mexico, South America. Bilcare successfully executed the project. The supplies were delivered before time along with the CoA and other necessary documents in place. Benefit: Owing to the extensive supply network of Bilcare, the client was able to secure their supplies to meet their stringent timelines. At Bilcare, we are very proud of our strong supplier network, which we consider one of our great strengths.
  • 15. Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited Introduction: A customer, based in US required an Innovator product for their RLD (Reference Listed Drug) need. They wanted to procure the drug from Japan and subsequently bring it to India. The customer engaged Bilcare GCS services to overcome this limitation. Challenge: Fetching the drug in Japan and exporting thereafter was an uphill task due to stringent control of the innovator companies on all the drugs in Japan. The customer was finding this challenging given the Language barrier and the CT project timelines. Outcome: Bilcare through its strong strategic partners in Japan, overcame this challenge and procured the required drug quantities. Owing to the vast experience in drug procurement and having handled various projects in various countries, Bilcare was able to explain and convince the innovator companies of the nature of the end-use of the required products. Benefit: A win-win situation wherein the customer was able to find a dependable partner and Bilcare was able to add another trustworthy and a long-lasting business relationship to its account. At Bilcare, we are very proud of our industry-wide experience, which we consider one of our great strengths. In the land of the Rising Sun
  • 16. Speed | Innovation | Happiness Privileged Information © 2008-2009 Bilcare Limited Introduction: Company headquartered in France with their subsidiary in Singapore required Cardiovascular Drugs to be procured from Philippines for CT purposes in Philippines. The customer engaged Bilcare GCS services for this special requirement. Challenge: The company had a threat of counterfeit drugs and were finding solutions to procure their required authentic quantity from a trustworthy partner. On the other hand, their was a pricing issue that the company was facing as the other alternatives were very costly and were threatening the sponsor budgets. The customer was finding this challenging and hence approached Bilcare GCS for authentic and cost effective solution. Outcome: Bilcare through its vast experience in pharmaceutical packaging and having key business relationships locally ensured uninterrupted supply of study products such that timelines as well as budgetary requirements are not exceeded. Benefit: Just in time services ensured that the client was able to conduct the Clinical Trial smoothly At Bilcare, we are very proud of our industry-wide experience, which we consider one of our great strengths. The Philippino Challenge
  • 17. Speed | Innovation | Happiness Thank you www.bilcareGCS.com “Experience Bilcare - Experience World Class Services” Dr. Abhigyan Upadhyay, Vice President- Business Operations abhigyan.upadhyay@bilcare.com