Bilcare GCS Comparator Procurement

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GlobalClinicalSupplies

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


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

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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


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


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


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


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

QuotationProvide 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.


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


Bilcare GCS - Depot Network

Expertise in handling temperature controlled shipments, monitor the temperatureduring 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


Summary

Bilcare GCS Comparator Procurement

Solutions

Expert Knowledge

Market Intelligence

Regulatory Compliance

Documentation

Secure Supply Chain

Quality Assurance


Comparator Procurement – Business Relationship

Asia EU Americas MEA

7 14 10 5

Asia EU Americas

9 2 9

Vendor Relationship

Sponsors/ CROs


COMPARATOR PROCUREMENT CASE STUDIES


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.


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


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


Thank you

www.bilcareGCS.com

“Experience Bilcare - Experience World Class Services”

Dr. Abhigyan Upadhyay, Vice President- Business [email protected]

mailto:[email protected]

Documents

Bilcare GCS Comparator Procurement