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
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
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