This presentation comprises information about clinical trial supply management.

1. Prepared By:
Dipesh Kashinath Pabrekar
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2. Clinical Trial Supply & Logistics Market - Insight
 Clinical trial supply and logistics is a management that is responsible
for providing clinical supplies needed for clinical studies of drugs or
medical devices in accordance with protocol and applicable
regulatory requirements. This process involves oversight of the
planning, packaging, forecasting, labeling, sourcing, distribution, and
clinical supplies for government and commercial sponsors whose
studies are in phase 1-4 clinical trials.
 The global clinical trial supply and logistics market size was valued
at US$ 14.95 Bn in 2017 and is expected to witness a CAGR
of 7.1% over the forecast period (2018 – 2026).
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Ref: https://www.coherentmarketinsights.com/market-insight/clinical-trial-supply-and-logistics-market-1798

3. Market Regional Outlook
 On the basis of region, the global clinical trial supply and logistics
market is segmented into North America, Europe, Asia Pacific, Latin
America, Middle East, and Africa.
 The number of new vendors trying to enter the healthcare industry
are expected to increase over the forecast period, as there are many
niche market players trying to leverage the market share through
new inventories in medical devices and drugs.
 emerging economies such as Asia Pacific and Latin America has huge
potential for market growth, and is projected to be the fastest
growing region over the forecast period.
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Ref: https://www.coherentmarketinsights.com/market-insight/clinical-trial-supply-and-logistics-market-1798

4. Key Players in Clinical Trial Supplies
 Some of the key players operating in the global clinical trial supply
and logistics market include
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5. What is Investigational Medicinal Product (IMP)
 ICH E6- 1.33 Investigational Product: A pharmaceutical form of an
active ingredient or placebo being tested or used as a reference in a
clinical trial, including a product with a marketing authorization
when used or assembled (formulated or packaged) in a way
different from the approved form, or when used for an unapproved
indication, or when used to gain further information about an
approved use.
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6. IMP Supply
Management
It is the journey where
GMP meets GDP and GCP
and this journey includes
flow of products,
information, finances and
documents and how a
company manages this
journey know as supply
chain management.
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7. Clinical Trial Supply Chain Interfaces
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8. Key Objectives of CTS
Get The Right Drug ToThe Right Patient In The Right
Time And Condition
Enrollment
rates and
dynamics
Changes in
site status
can affect
supply
strategies
Managing
Customers
Maintain
good
relationship
with all
relevant
stakeholders
Retest
Process
Expiration
of IP,
resupply
packaging
lead time to
the site
Storage
Storage
capacity,
storage
equipment
of site and
size of the
shipper
Shipping
TOT
Primary and
secondary
transport.
Site to
patient
delivery
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9. Project
Manager
QA
Regulatory
DM
Bio stats
IRT
RTSM
Vendor
CMO
CRO
CTM
CRA
Includes field
monitors and
site
coordinators
Includes
Toxicologist
(Phase 1
trials) &
stability
scientist
Includes
qualified
person, QA,
auditors
Includes
data team
and
statistical
programmer
Includes
CTSM
admin,
forecasting
analyst
Includes
3PL depots,
courier
services
CTS Management Stakeholders
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10. CTS Project Kick Off Guide
Step 1
Outline the
responsibilities
•Production and procurement of IMP
•Packaging design
•Packaging and labeling. Master Labels
•Stability data and QP certification.
Step 2
Supply Chain
Management
•Storage & distribution incl. depot management
•IMP Projection
•Vendor Management
•IMP reconciliation and accountability
•EXIM & temp excursions management
Step 3
Documentation &
trial process set up
•Technical agreements
•Software integration
•IMP handling guide
•Align with clinical operations
• Shipping and project documents
•Training
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11. Challenges in CTS Management
CTS
Challenges
Lack of data for
Accurate forecast
Cross vendor
alignment
Logistical
Challenges
Multiple
Languages
Country Specific
Regulations
Patient Enrollment
Shorter time
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12. Form cross functional strategic partnership to mitigate
risk, time and cost.
Marketers must link the price to
the real and perceived value of
the product, but they also must
take into account.
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Measures to tackle CTS challenges
Pre defined work processes for external stakeholders
Active engagement in timeline management across
cross function deliverables
Less experienced sponsors may opt for partnership
with service providers to reduce CTS challenges
IRT could be critical success factor in proper supply
management.
Review, monitor and validate processes and system
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13. Current Trends in Clinical Trial Supply
 Pharmaceutical companies are progressively partnering with service
providers to manage their supply chain
 Moving from ad hock interactions to partnership based relationship
 Supply chain organizational structure is becoming more and more
complex
 More trials, more regulations, more regions, more resources
 Increase in cold chain logistics and distribution
 Due to shift from small to large molecule of drugs
 Accurate supply forecasting becoming even more significant.
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14. Thank You
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