Introduction to CDM

Why CDM Review & approval of new drugs by

Regulatory Agencies is dependent upon a trust that clinical trials data presented are of sufficient integrity to ensure confidence in results & conclusions presented by pharma company

Important to obtaining that trust is adherence to quality standards & practices

Hence companies must assure that all staff involved in the clinical research are trained & qualified to perform data management tasks

The Scenario Drug development is becoming more &

more global Parallel multi-centric trials in US & Europe

across continents is now common which leads to simultaneous regulatory submission

With increase in globalization & consequent need for increased data management expertise needed for global submissions, data management organizations are being set up all over the globe

Global CDM Market

CDM is a significantly under leveraged outsourced opportunity for India

Global DM

Market

% Outsou

rced

2004

1.3 35%

2005

1.61 40%

Own estimates based on Industry R&D numbers reported by PhRMA & European Commission. Clinical estimated as 35% of the total R&D exp. DM estimated to be 15% of clinical. Extent of outsourcing is assumed to be 35% in 2004, increasing to 40% in 2005.

1.86

1.29

2.07

1.34

2.33

1.39

0.00

0.50

1.00

1.50

2.00

2.50

US Europe

2002 2003 2004

All figures in USD Bn.

Global Data Management spend

21 Jan 2006

Crux of the problem

Clinical Data Management positions are hard to fill, partly because many potentially good candidates do not have necessary training & experience

Companies don’t have resources or time to train inexperienced people from scratch

India Advantage

Source: NASSCOM – McKinsey. 2002

Location Attractiveness Infrastructure Country-specific risks Time zone attractiveness

High

HighLow

Low

ChinaIndia

U.K.

Mexico

Philippines

Ireland Australia

Singapore

Note: Size of circle indicates resource availability

People Strength Skills quality Resource costs Language abilities and other skills

•180,000 Engineering graduates per annum!

•70% of CMM level 5 companies are in India

•185 of Fortune 500 outsource IT services to India

21 Jan 2006

CDM Process

DATA PAPER CRF FROM

SITES/HOSPITALS SENT TO SCAN

ENTERED DATA CLEANED/VALIDATED

BOTH AUTOMATED VALIDATIONS AND

MANUAL DISCREPANCY

RESOLVED

FINAL ANALYSIS DONE FOR SAFETY

AND EFFICACY

STUDY CENTERS

DATA ENTERED INTO ORACLE DATABASE

INVESTIGATOR ANSWERS QUERY

FAXED TO HIM

LOGICAL CHECKS IN

ORACLE RUNAFTER FREEZING

BIOSTATICIANS DO ANALYSIS

FREEZING OF DATABASE AFTER ALL DATA IS CLEAN

CDM Process

Investigator Monitor

CentralLaboratory

Data Manager

Statistician

Clinician

RegulatoryAuthority

Subject

CRF

DCF

CRF DCFSample

LabResults

ClinicalData

NDA

21 Jan 2006

Core CDM Processes DATA ACQUISITION

Data Collection Tool Design (paper) Data Collection Tool Design

(electronic) DATA STORAGE

Database Structure Specification Forms Management Data Archival (paper & electronic)

Core CDM Processes DATA PROCESSING

Forms Processing Data Entry Coding Cleaning (manual clinical review &

programmatic checks) DATA VALIDATION

Design of Data Validation Strategy Specification of Design

Core CDM Processes LAB, SAFETY REPORTING & OTHER

EXTERNAL DATA Data Transfers & Loads Database Reconciliation

DATA QUALITY Auditing Quality Control Procedure Statistical Sampling Quantification of Database Quality

Core CDM Processes DATABASE CLOSURE

Lock Criterion & Approval Breaking the Blind Handling of Post-lock Errata

VENDOR MANAGEMENT Vendor Selection Vendor Monitoring

Why Technology in CDM

• More automation reduces manual input

• Allows processes to be linked • Allows re-use of established models• Increases processing speed• Stores large volumes of data• Enables to get answer that may

eliminate need for further studies

Why Technology in CDM

• Web-based technologies allow site involvement earlier

• Enables global studies• Can reduce time to move data

downstream• Automates tracking of processes• Eliminates or simplifies steps in

process

Why Technology in CDM

• More updated information available in real time

• Reduces chance of human error• Electronic data more

accurate/eliminates guessing• Automated queries will have

consistent terminology across sites

21 Jan 2006

Head Clinical Data Management and Biometrics

Head Data Management

QUALITY SYSTEMS DATA MANAGEMENT BIOSTATISTICS

Head Biostatistics

Sr. Statisticians

Statisticians

Statistical Programmer

Project Team Leads

Project Team Leads

Data Entry Associates II

Lead Data

Coordinators

Senior Data

Coordinators

Data Coordinators

Data Entry Associates I

Medical Coding

Safety Reporting

IT Services

Applications Administrator

Applications Developer

CRF designer

Hardware Engineer

Head Quality

QALead

DM Lead

Data

reviewer

Coding

& Safety Review

Report auditor

SOP’sDevelo

per

Validator

Trainer

OTHER PLAYERS ASSISTING CDM PERSO NNEL IN CLINICAL

RESEARCH

Code of Ethics for CDM ProfessionalsClinical Data Management is a key component of

the development of new medications, medical procedures & devices

Clinical Data Management professionals are:

Committed to following the laws & guidelines applicable to clinical research (including the Declaration of Helsinki), to participate in the protection of the safety, dignity & well being of patients & to maintain the confidentiality of medical records

Code of Ethics for CDM Professionals Committed to creating, maintaining & presenting

quality clinical data, thus supporting accurate & timely statistical analysis, & to adhering to applicable standards of quality & truthfulness in scientific research

Committed to facilitating communication between clinical data management professionals & all other clinical research professionals, to maintaining competency in all areas of clinical data management, to keeping current with technological advances, & to ensuring the dissemination of information to members of the clinical research team

Code of Ethics for CDM Professionals Committed to working as an integral member

of a clinical research team with honesty, integrity & respect

Commited to making & communicating accountability for clinical data management decisions & actions within the clinical trial process

Committed to maintaining & respecting proprietary knowledge at all levels, to avoiding the use of proprietary knowledge for personal gain, & to disclosing any conflict of interest

Code of Ethics for CDM Professionals Committed to avoiding any conduct or

behavior that is unlawful, unethical or that may otherwise reflect negatively on the profession of clinical data management

Committed to advancing the profession of clinical data management through the development, distribution & improvement of good clinical data management practices

Committed to aiding the professional development & advancement of colleagues within the clinical trial industry