the use of electronic systems in early phase clinical studies for ensuring gcp compliance - vinoth...
DESCRIPTION
This presentation describes the potential use of electronic systems to increase GCP compliance during the conduct of early phase clinical trials. It also speaks about the benefits and the considerations of 21 CFR Part 11 compliance while choosing and implementing electronic systems in clinical trial units.TRANSCRIPT
The Use of Electronic Systems
in Early Phase Clinical Trials for
Ensuring GCP Compliance
Mr. Vinoth Kumar T
Assistant Manager – Delivery Lead
(E-Clinical Technologies)
Interpreting Life Sciences Solutions
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
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6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
• Characteristics & Overall Process of Early Phase Studies
• Issues & Reasons for GCP Non-compliance in Early Phase Studies
• Potential Electronic Systems for Early Phase Clinical Units
• Benefits of using Electronic Systems in Early Phase Clinical Studies
• Electronic Systems Implementation Considerations
• Summary
Agenda
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
• Includes Phase 0 to Phase IIa Clinical Trials
• Conducted through volunteer recruitment and constant
bedside monitoring
• Protocol requirements include time dependent clinical
pharmacology assessments (PK/PD, SAD, MAD Tests)
Characteristics of Early Phase Studies
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
• Trial activities require various critical sample collection,
aliquoting, packaging and shipment procedures
• A labor intensive process involving regular daily
communication different personnel teams
• Overall these studies require meticulous planning, monitoring
and governance
Characteristics of Early Phase Studies
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
STUDY
CLOSURE
STUDY
CONDUCT
Overall Process of Early Phase Clinical Trials
STUDY
STARTUP
VOLUNTEER
RECRUITMENT
Volunteer enrollment
Volunteer participation history tracking
Volunteer screening
Volunteer recruitment
Resolve and close all queries
Consolidation of all external and internal study reports
Drug Accountability and Safety Reconciliation
Preparation & Submission of Final Study Report
Complex clinical pharmacology assessments
Record trial data Entry
Generate and manage queries online and off-line
CRA Monitoring
Sample collection, aliquoting & Shipment
Environment and IP Management Immediate reporting of AE and SAE’s
Study specific Labels creation
Designing of Paper CRF/ e-CRF Study IP and sample Inventory Tracking & Management
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Issues & Reasons for
GCP non-compliance in Early Phase Studies
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Issues of GCP compliance in Early Phase Studies
GCP INSPECTIONS METRICS REPORT - Phase I Clinical Units
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Issues of GCP compliance in Early Phase Studies
Major Non – Compliance issues occurred during :
Volunteer Identification & Recruitment
Investigator Procedures in Early Phase Trials
IMP Dispensing & Management
Source Data Verification
Study Documentation
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Error Sources for GCP Non – Compliance
Lack of GCP guidelines knowledge
Lack of a consolidated study information database
Lack of critical study procedure warnings and reminder alerts
Absence of end to end tracking facility for all trial activities
Manual preparation of study procedure labels
Lack of Real time Data Availability & Safety Reporting
Lack of a controlled Document Management system
Lack of automated facility for environment monitoring
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Potential Electronic Systems for Early Phase Clinical Units
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Why use Electronic Systems ?
SPEED
• Achieved through Automation
• Increased by Real time Data Availability
EFFICIENCY
• Achieved by device & apps Integration
• Better Process Control
• Proactive organizational Communication
COMPLIANCE
• Achieved with the sensitive Audit Trail
• Errors minimized through alerts and warnings
To Improve & Increase …..
Increase Value Proposition of the Organization
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Tablet PC and Personal Digital Assistant (PDA)
Medical Devices (Pulse Oximeters, Glucometers,
Spirometers)
Barcode Generator and Scanner (1D, 2D and 3D Barcodes)
Biometric Devices (Finger printing, Retina scan etc.)
Integrated Environment Sensors
Bluetooth Mobile devices
Centralized EDC Application - IVRS
Document Management Systems for e-Submissions
Wireless Network Technologies (SMS, E-mail)
Potential Electronic Systems for Early Phase Clinics
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Potential Electronic Systems for Early Phase Clinical Units
Early Phase Clinical Trial
Electronic Devices
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Electronic Systems in Early Phase Clinical Trials
Volunteer Verification
Volunteer Recruitment
Clinical Study Setup
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Favors informed decision making
Generates trial specific error alerts and warning messages
Helps in tracking time taken for completing a medication procedure
Transcribes sensitive information in a machine readable format –
Thus maintains confidentiality & data security
2D Barcodes can also store email IDs, hyperlinks, Phone numbers,
pictures, SMS/MMS and Calendar Entries
Significance of Barcodes in Early Phase Studies
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Electronic Systems in Early Phase Clinical Trials
Study Conduct
Query Management
Study Closure
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
1. Electronically Automated Process - Volunteer Recruitment
Centralized Study Database
Volunteer Biometrics
Telephone Screening
Volunteer Screening Form Volunteer Enrollment
Volunteer ScreeningOnline Data EntryVolunteer
Database
Barcode ID &
Label GenerationVolunteer
Wristband
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
2. Electronically Automated Process - Study Start Up
Centralized Study Database
Print volunteer linked
Clinical Sample Labels
Study E – CRF
Design & Edit Checks
ProgrammingPerform Environmental
Monitoring
Setup Freezer,
Sample storage
& Ward Temperature Alerts
Stick & scan Sample Barcode Labels / Volunteer
Configure wireless Network in the clinic ward
Sample vessel
allocated / volunteer
Document
Management System
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
3. Electronically Automated Process - Study Conduct
Centralized Study Database
Record Volunteer Clinical
Sample Collection Time
Instant Online Queries
during E-CRF
Data Entry on Tablet PC
Scan Sample Barcode Labels / Volunteer
Record trial data using Bedside Medical Devices
Time alerts and warnings
on Mobiles and PDA’s
Sensitive Lab Instruments
& Temperature AlertsBlinding, Randomization,
IP Dispensing & Tracking
CRA Monitoring
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
4. Electronically Automated Process - Study Closure
Centralized Study Database
Drug Accountability
Volunteer Exit
Study Queries
resolved
Database
Lock
Study Documents Tracking & Archival
Written on to CDs
for regulatory
submission
Final Study
Reports Volunteer Trial
participation Tracked
Quality
Control
Drug Safety Database
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
4. Electronically Automated Process - Study Report Submission
Centralized Study Database
E-Submission
Gateway
Prepare Study data in the
eCTD – Electronic Common
Technical Document format
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Benefits of using Electronic Systems
in Early Phase Clinical Studies
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Sensitive audit trail Increased GCP Regulatory Compliance,
lesser audit queries
Process automation through applications & medical devices
integration Achieve end to end operational excellence
Electronic Data Entry & Alerts Eliminate erroneous, time
consuming - Manual data entry, Label preparation and QC
procedures
Real Time Data Availability Facilitates Study performance (Drug
& Volunteer) evaluation and overall study activities tracking
Benefits of using Electronic Systems
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Centralized Study Database Integration of data from
different instruments and devices, Enhances speedy
query resolution and facilitates generation of in-built
periodic and final study reports
Electronic Data Favors FDA recommended e-
submission of clinical data for approval
Overall it increases the value proposition, operational
excellence and confidence on quality of research
conducted by the organization.
Benefits of using Electronic Systems
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Electronic Systems Implementation
Considerations & Overall Plan
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Considerations in the use of Electronic Systems
21 CFR Part 11 Compliant
Accurate, complete, timely, verifiable and easy to use
Secure with no loss of performance, stability & availability
Integration capabilities with the centralized database
Sensitive in recording & alerting minute errors
Easily maintained and re-validated over a period of time
Facilitate reduction of resources (Manpower, Time & Money)
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Electronic Systems – Implementation Plan Items
1• Perform exhaustive vendor analysis
2• Evaluate regulatory compliance & product performance
3• Perform risk evaluation & mitigation activities
4
• Examine electronic system integration & continuous support
5• Estimate costs, effort & resources involved
6
• Prepare, review and approve the “Change Management Plan & Process”
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Implementing Electronic Systems in Clinical Units
Strategize Design Transition Operate Improve
Determine Scope,
Resources, Level
of electronic
automation
requirements
Evaluate process
risks and
compliance
constraints
Re-engineer the
current process,
implement and
validate the
electronic system
Evaluate & change
organizational
structure and
workflow
governance
Build and test
mock study
workflows and
associated
processes
Provide training
and validate the
entire study
design & conduct
lifecycle
Execute and
support trial
activities with the
newly tailored
process
Continuously
monitor the
processes and
perform gap
assessments
Implement CAPA
and evaluate
process loop holes
Identify
opportunities for
increasing
compliance,
operational
excellence and
business value
Processes
Electronic Systems & Information Technology
Organization Governance & Reporting
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Early Phase Clinical Studies involve time-based complex clinical
assessments with the additional constraints of volunteer recruitment
targets, constant bedside monitoring & sample management
The scope for GCP non-compliance is increased by the challenges of
timely communication & parallel conduct of study activity procedures
Electronic Systems such as barcode scanners, IVRS, EDC systems etc.
have proven to significantly increase GCP compliance with the salient
features of process automation, sensitive audit trail & Real time data
availability
The use of electronic systems require meticulous planning in the vendor
selection and implementation process and should take place with the
organization‟s overall „Change Management‟ approach.
Summary
6th Annual Conference on Global Drug Development and Market AccessOctober 15-18, 2011 | Mumbai, India
Conclusion
Thank You for your attention !
For further information, assistance & queries you are most welcome to contact us.
Vinoth Kumar T
Techsol Corporation, Hyderabad
M: +91 - 9666366782
W: www.techsolcorp.com
Interpreting Life Sciences Solutions