IT Life Sciences
Summit 2012: Technology Enabled
Pharmaceutical Business
Transformation
September 6-7, 2012 | Mumbai, India
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
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Simplifying Clinical
Quality Management
(QM) using established
IT industry practices
7 Sep 2012
Rajeshwari Bijur Associate Director, Operations Quality Clinical Data Management, Quintiles
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
• Current Challenges in Clinical Trials Quality Strategies
• Quality Model Implementation in the IT industry
• Effectively implementing IT QM practices in Clinical
Data Management
• Expanding the benefits to QM in Clinical Trial
Agenda
4
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
CLINICAL QUALITY & IT INDUSTRY
PRACTICES
Applicability of Simple techniques from IT Quality Models in Clinical Trials
5
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
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• Clinical Trials Quality strategy focus on Audits /
Inspections
• There is a need to change the focus from inspection-
based quality improvement to planned systematic
quality management
Building Quality in clinical trials with use of a quality systems approach. Clin Infect Dis 2010;51 (Suppl
1):S111-6. [FULLTEXT] Kleppinger CF, Ball LK., Division of Scientific Investigations, Office of Compliance,
Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, USA.
Current Challenges in Clinical
Trials Quality Strategies
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
CMMI - IT Industry model implementation
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Level 1 Initial
Level 2 Managed
Level 3 Defined
Level 4 Quantitatively
Managed
Level 5 Optimizing
Process unpredictable,
poorly controlled and reactive
Process characterized for
projects and is manageable
Implement Defect, Effort Tracking tools
Lessons Learnt Data Collection & Statistical Analysis
Data enabled Continuous Improvement Strategies
Implement organization wide Training Management, Project management, Configuration management tools
Process characterized for
the organization and is proactive
Process quantitatively measured and
controlled
Focus on continuous process
improvement
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
Clinical Trials
8
Planning Start-up Execution Analysis Reporting
Protocol
Statistical Design
Drug Supply
IVRS
eDC/ CTMS setup Data Cleaning /
Coding
LIMS, Imaging
Patient Enrollment &
Data Entry
Statistical Analysis
Ongoing clinical data
analytics
PVC / Safety
Regulatory Affairs
Data and e/TMF
Submission
Project Management
e/TMF Management
Quality Management
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
Focus on CDM
9
Planning Start-up Execution Analysis Reporting
Protocol
Statistical Design
Drug Supply
IVRS
eDC/ CTMS setup Data Cleaning /
Coding
LIMS, Imaging
Patient Enrollment &
Data Entry
Statistical Analysis
Ongoing clinical data
analytics
PVC / Safety
Regulatory Affairs
Data and e/TMF
Submission
Project Management
e/TMF Management
Quality Management
Defect Tracker
Training PM, CM
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
TRAINING MANAGEMENT
Electronic SOPs Compliance processes
10
Defect Tracker
Training PM, CM
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
ESOP Compliance Management
11
Low Compliance indicating new employee/ long leave requiring Manager’s focus
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
CONFIGURATION MANAGEMENT
12
Electronic Study Filing and review process
Defect Tracker
Training CM
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
Electronic Study Files
13
Easy globalised Filing process
Clear Version Control
Document Change Management
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
Study File Review process
14
Real-time planning
Standardized online review template
Workflow based Issue tracking
Automated quantitative reports
Analytics and feedback trends
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
DEFECT TRACKER
Review and Testing Defects logging and tracking process
15
Defect Tracker
Training PM, CM
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
Defects Tracker
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Effective Reviews/ Test cycles during Start-up phase: • Design Reviews • TestCase Reviews • Testing cycles
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
PROJECT MANAGEMENT
Project Health Review process
17
Defect Tracker
Training PM
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
Project Health Review
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Periodic Review of Project Health on various parameters :
• Finance • Resourcing • Documentation • Timelines • Risk
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
BENEFITS IN CLINICAL DATA MANAGEMENT
Benefits in CDM & Continuous Improvement Strategies
19
Defect Tracker
Training PM, CM
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
Effective Review and Testing cycles, thereby reducing later Rework effort
by over 30%
Benefits in CDM
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Defect Tracker
Training PM, CM
Overall QA findings reduced by over 50% within a year of Implementation
Electronic Study Filing &
Review process
Timely SOP Compliance helped in reducing QA findings and enhanced
process knowledge of staff
Electronic SOP
Compliance Management
Defects logging & Tracking process
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
Continuous Improvement Strategies
21
SOP’s
Long Term process excellence
Each project uses tools and follows processes
as specified in the SOP’s and generates
Relevant metrics
Metrics report at end of each project
gets into the company-wide Metrics Database
The Metrics Database Is periodically analyzed to
determine the Process Capability Baseline
Process Capability Baseline will enable us to modify
relevant SOP’s and/or create more robust trainings.
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
SIMPLE QM SOLUTIONS FOR
CLINICAL TRIALS
Expanding the QM Benefits
22
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
Simple Solutions for Clinical QM
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Trial Master File Inconsistencies
Electronic Study Filing and Review process
Training & SOP Inconsistencies
Electronic SOP/ Training Compliance Management
Inadequate Quality Control & Reviews
Electronic Defect/ Issue Management process
Key Clinical Quality Challenges
IT Life Sciences Summit 2012: Technology Enabled Pharmaceutical Business Transformation
September 6-7, 2012 | Mumbai, India
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