simplifying clinical quality management using established it industry practices

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


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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



• 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



CLINICAL QUALITY & IT INDUSTRY

PRACTICES

Applicability of Simple techniques from IT Quality Models in Clinical Trials

5



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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

http://www.cid.oxfordjournals.org/cgi/pmidlookup?view=long&pmid=20597658



CMMI - IT Industry model implementation

7

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



Clinical Trials

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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



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



TRAINING MANAGEMENT

Electronic SOPs Compliance processes

10

Defect Tracker

Training PM, CM



ESOP Compliance Management

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Low Compliance indicating new employee/ long leave requiring Manager’s focus



CONFIGURATION MANAGEMENT

12

Electronic Study Filing and review process

Defect Tracker

Training CM



Electronic Study Files

13

Easy globalised Filing process

Clear Version Control

Document Change Management



Study File Review process

14

Real-time planning

Standardized online review template

Workflow based Issue tracking

Automated quantitative reports

Analytics and feedback trends



DEFECT TRACKER

Review and Testing Defects logging and tracking process

15

Defect Tracker

Training PM, CM



Defects Tracker

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Effective Reviews/ Test cycles during Start-up phase: • Design Reviews • TestCase Reviews • Testing cycles



PROJECT MANAGEMENT

Project Health Review process

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Defect Tracker

Training PM



Project Health Review

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Periodic Review of Project Health on various parameters :

• Finance • Resourcing • Documentation • Timelines • Risk



BENEFITS IN CLINICAL DATA MANAGEMENT

Benefits in CDM & Continuous Improvement Strategies

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Defect Tracker

Training PM, CM



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



Continuous Improvement Strategies

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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.



SIMPLE QM SOLUTIONS FOR

CLINICAL TRIALS

Expanding the QM Benefits

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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



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simplifying clinical quality management using established it industry practices

Documents

india clinical quality

clinical quality management

quality models

life sciences summit

quality systems approach

project management

clinical trial agenda

managed level