Effectively Managing The Clinical Trial Materials Supply Chain

Effectively Managing the Clinical Trial
Materials supply chain

Emily Tan
Executive Director, Asia Pacific
PharmaNet
2010 PharmaNet Development Group, Inc. All rights reserved.
Experience You Can Trust
Areas to be covered
Proper Planning between clinical operations and supply chain
Forecasting and planning tools
Parties involved - contract manufacturing, couriers, depot, supply chain

coordinator, clinical project teams, IVRS, investigator sites
Issues and challenges in Asia Pacific
Page 2
PLANNING A STUDY
Page 3
What factors should be considered in planning clinical

supply needs
Trial size
Number of patients in study

Number of countries (Number of regions)
Number of sites
Number of patients per site
Trial design
Blinded/unblinded studies
Number of study arms
Adaptive design
Duration of study, number and interval of visits, dispensing periods
Page 4
What factors should be considered in planning clinical

supply needs
Timelines
Protocol development to FPI

Is there enough time to obtain ALL import licenses
Is there enough time to manufacture, procure, label and ship drugs to site
Type of product
Formulation and dosage form
Shelf life of investigational product do you have sufficient stability data
Storage requirement
Need for frequent re-supplies
Availability of comparator products
Packaging and labelling of trial products
Handling requirements: radioactive? Controlled drug? Biologic?
Page 5
What else does the Project Manager need to plan for
Forecasting quantity needed at each site critical
Impact of poor planning
Enrolment has to be stopped while waiting for drugs to arrive
Ongoing patients do not get their drugs on time, study treatment

interrupted
Ensure the following areas are considered
Study approval timelines
Recruitment rate
Size and space needed
Quantity to be shipped each time
Preferred route: direct to site or to local depot
Cost of drug
Page 6
Comparator Drugs
Should comparator/concomitant drugs be supplied?
Key considerations
If supplied, considered investigational
Needs to be included in import permit application

Do not forget documentation requirements
Who is responsible for sourcing
Who is responsible for labeling
Straightforward for sites, but generally high cost for sponsors
Page 7
Regulatory Documentation
Labels
Certificate of Analysis
Import License
Material Safety Data Sheet
Packing List
Proforma Invoices
Temperature Records
Others eg dangerous goods documentation

Page 8
Clinical Supplies Depot
GMP/ GDP certification
Order Processing Time
Location of depot vs location of trial sites
Global central vs regional hub vs in country

Hybrid model
Preferred Courier
Receipt and Inventory control process
In Europe, consider requirements for QP release and compliance

with annex 13
IP Return and destruction procedure

Page 9
Budgeting for Clinical Supplies Depot Vendor
Logistics set up procedures
Project management: duration of study
Receipt procedures: number of receipts
Packaging, labeling and QP release (if required)
Storage of study drug: duration of storage, space needed
Despatch/ Shipment: number of shipments
Returns procedure
Storage of returns
Destruction costs
Project closedown
Page 10
Budgeting for Clinical Supplies Depot Vendor

Pass-through costs
Study Specific Materials sourcing and purchase
Regulatory fees
Import re-export licence fees
Courier costs
Concomitant drugs
Shipping materials
Temperature recording devices
Equipment (eg. Freezer)
Customs clearance fees

Drive away charges
Weekend surcharge
Fuel charges
Depot Fees
If vendor is sub-contracting to local depots for importation of study drug(eg.

Page 11
Often preferable in China,India,Russia,Ukraine)
Use of Couriers
Important considerations
Handling temperature excursions during shipment
Experience with customs clearance and use of ground staff
Number of shipments depends on

Randomization design
Storage space needed
Cost of drug
Shelf life of drug
Provision of packing materials
Keeping local staff informed is important to ensure seamless

process
Page 12
RUNNING A STUDY
Page 13
Study Site requirements

General:
Qualified Person: pharmacist
Qualified Facilities:
Built-in alarm system
Connection to a central surveillance system
Back-up power system in place
Restrict access to the responsible staff only
Dispense the products to eligible subjects only
Documentation: Inventory Log, Drug Dispensing Log, Drug Accountability Log

Check for expiry dates and avoid late detection of study drugs running out of shelf life
Recruitment plans: must be prepared and reviewed regularly
Ensure proper training is provided to site staff in handling of trial products
Page 14
Temperature
Temperature Control:
Follow the requirements listed on Label, IB or other available documents

Recording continuously including weekend and holiday
Handling Temperature Deviations:

Any temperature excursion during storage at the trial site should be documented
Take and document appropriate actions taken
Report the temperature deviation to sponsor/ CRO immediately.
Stop further distributing the trial supplies on question.
The samples on question should be sent for further evaluation; and meanwhile, the trial
supplies on question should be held in quarantine.
Page 15
Forecasting
Important to have accurate forecast of enrolment rate and quantities needed at
each site
IVRS/ IWRS systems should be integrated with EDC and Project Management
Tools to capture real-time progress.
Site activation and green light status
Shipment trigger
Use of IT coupled with good communications!
Setting clear expectations
Ensuring mutual understanding of responsibilities & assumptions
Face-to-face interaction-training, feedback
Managing performance through metrics
Page 16
Forecasting tools
Need to develop a robust site recruitment and retention plan
Supply scheme should be flexible and adjustable with the predicted recruitment speed (IV/WRS
supply scheme: low, medium, high level ).
Re-order/
Trigger
level
Page 17
Forecasting tools
Page 18
CLOSING A STUDY
Page 19
Activities in returning study drugs

Consider amount of space at site and size of study drug
Perform reconciliation of study drugs before any collection

Obtain confirmation from sponsor if drugs are to be destroyed or returned
Notify courier with accurate pick up time and address
Ensure destruction is done in accordance with environmental regulations

Documentation:
accountability logs must be updated
All documents must be reconciled: proforma invoice, IVRS drug allocation

printouts, inventory and dispensing records, acknowledge of receipt, returns/
despatch
Do not put off reconciliation to the end
Page 20
ISSUES AND CHALLENGES IN

ASIA PACIFIC
Page 21
Issues and challenges in Asia Pacific

Site Level
Responsibility for study drugs: study nurse versus pharmacist
Inadequate facility: eg need to supply fridge in some countries
Missing drugs from sites?
Patients do not return drugs!
Sponsor Level
No clear plan of what to do in the event of temperature excursions
Too conservative or too aggressive planning of study timelines
Country level
Unpredictable/ Changing customs regulations
Wide variations in infrastructure across different countries
Page 22
Delayed Shipment
Common Causes
Communication gap between IVRS, depot and CRA

eg Depot or IVRS does not notify CRA of planned shipment
Incomplete documentation for customs clearance
Minimum quantity / trigger quantity set inappropriately with respect to

enrolment rate
Couriers with inexperienced ground staff at customs
Delivery duty paid?
Page 23
Questions
etan@pharmanet.com

Effectively Managing The Clinical Trial Materials Supply Chain

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Effectively Managing the Clinical Trial

Materials supply chain

2010 PharmaNet Development Group, Inc. All rights reserved.

Experience You Can Trust

Proper Planning between clinical operations and supply chain

Forecasting and planning tools

Parties involved - contract manufacturing, couriers, depot, supply chain

Issues and challenges in Asia Pacific

Experience You Can Trust

Experience You Can Trust

What factors should be considered in planning clinical

Number of patients in study

Number of patients per site

Experience You Can Trust

What factors should be considered in planning clinical

Protocol development to FPI

Experience You Can Trust

What else does the Project Manager need to plan for

Forecasting quantity needed at each site critical

Impact of poor planning

Enrolment has to be stopped while waiting for drugs to arrive

Ongoing patients do not get their drugs on time, study treatment

Ensure the following areas are considered

Study approval timelines

Size and space needed

Quantity to be shipped each time

Preferred route: direct to site or to local depot

Experience You Can Trust

If supplied, considered investigational

Needs to be included in import permit application

Who is responsible for sourcing

Who is responsible for labeling

Straightforward for sites, but generally high cost for sponsors

Experience You Can Trust

Material Safety Data Sheet

Others eg dangerous goods documentation

Experience You Can Trust

Clinical Supplies Depot

GMP/ GDP certification

Order Processing Time

Location of depot vs location of trial sites

Global central vs regional hub vs in country

Receipt and Inventory control process

In Europe, consider requirements for QP release and compliance

IP Return and destruction procedure

Experience You Can Trust

Budgeting for Clinical Supplies Depot Vendor

Logistics set up procedures

Project management: duration of study

Receipt procedures: number of receipts

Packaging, labeling and QP release (if required)

Storage of study drug: duration of storage, space needed

Despatch/ Shipment: number of shipments

Experience You Can Trust

Budgeting for Clinical Supplies Depot Vendor

Import re-export licence fees

Customs clearance fees

If vendor is sub-contracting to local depots for importation of study drug(eg.

Experience You Can Trust

Handling temperature excursions during shipment

Experience with customs clearance and use of ground staff

Number of shipments depends on

Provision of packing materials