CLINICAL TRIAL SUPPLIES

• Dr Pravina K
• ICRI, Bangalore
Clinical Trial Supplies
Management

GMP & GCP

Co-ordination and Management
 Glossary
• CTS
• CTM
• IP
• IMP
• CTSM
 CTSM
Manufacture Distribution
Placing orders Dispatch
Packaging Disposal
Labeling Documentation
 KEY TOPICS
 Techniques that streamline the
clinical supply process
 Interrelationships of the clinical
supply personnel
 Good manufacturing processes
(cGMP)
 Good clinical practices
(GCP)concepts
 Sponsor’s obligations during the
preparation, use and return of IP
 Role Players
Clinical Supply pharmacist (F&D)
Project manager
Medical monitor
Clinical research associate
Investigator
Hospital pharmacist
Regulatory professional
Quality assurance auditor
Compliance officer
 Placing an order for CTS
Person in charge

Place

Documentation details

LEAD TIME

Request for additional supplies

 Manufacturing details

GMP
Varies with Phases of CT

Quantity
Stability
Dispensing form
Place of manufacturing
Stocks
 Blinding
Controlled clinical studies

Comparator
Placebo
Active
Test drug ( Different dosage/form)
 Packaging
Selection w.r.t. stability data

Dosage form specific

Packaging of Comparator

Accountability

Patient compliance
 Labeling
As per regulatory requirement

Clinical trial design

Blinding

Package – inner/outer

Language

Special instructions
 Delivery of supplies
Shipment details

Tracking of dispatch

Special storage/transportation requirements

Global studies
 Investigator’s Role
Accountability

Co-ordination with Hospital Pharmacist

Distribution to patients

Patient compliance

Disposal
 Hospital pharmacy staff 1
Co-ordination with Investigator
Purpose of the trial
Description of the marketed product
Storage instructions
Numbers and recruitment parameters of
patients as trial participants
Randomization code
 Hospital pharmacy staff 2

Source of products to be used

Labeling to be used
Name and contact details of the Chief
Investigator, local investigators and others
involved in organizing, managing or
administering the trial
Documentation to be retained by the pharmacy.
 Key barriers for
clinical supplies chain
Increasing complexity study design
Changing international regulatory
requirements
Greater number of trials across different
global sites
Slow adoption of IT tools for planning
and management
 key areas for enhancing clinical
supplies performance:
· Incorporating a supply chain view of clinical
drug supply processes
· Keeping clinical supplies delivery off the
clinical trials critical path
· Maximising efficiencies in the clinical trials
materials supply chain
· Scaling clinical supplies capacity without
replicating the current asset base
· Using and tracking adequate performance
measures
 CTSM & IVRS

Medication List
C Shipment Request I
T V
Dispatch Request
S R
Shipment Receipt Notification S
M
Drug Dispensation
 CTSM & IVRS - Data
elements
Medication details
Kit ID
Batch Number
Lot Number
Expiry Date

Consignment Details
Shipment ID
Sent Date
Receipt Date
.
 Clinical Trials Supplies for Drugs
and Biologics -1
Prior to phase I:
• need product safety testing and basic
characterization information, cell bank
characterization

Prior to Phase II:

• requires nearly completed safety profile and
further characterization of the product (stress
testing), process controls, assay descriptions,
beginning specifications or limits
 Clinical Trials Supplies for Drugs
and Biologics -2
• Phase III requires full characterization:
– Impurities profiles
– Specifications: Identity, Potency, Purity, Safety
– Raw materials testing
– Stability testing Process Validation
– Container/closure Analytical Validation
– Process controls Equipment Validation
– Batch records Facility Validation
– Yield expectations
 LEARNING OBJECTIVES
•Scope of CTS activities required to
provide quality investigational and
supplemental materials
• Uniqueness of clinical supply
operations at R&D
• Concepts and processes for
translating clinical protocol
requirements into accurately
packaged and labeled drug
products
• Logistics and regulatory