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
All figures in USD Bn.
2.50

2.33 2.07
2002 2003 2004

Global % DM Outsou rced Market 2 004 2 005 1.3 1.61 35% 40%

2.00

1.86 1.39

1.50

1.29

1.34

1.00

0.50

0.00 US Europe

Global Data Management spend

CDM is a significantly under leveraged outsourced opportunity for India
Source: 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% 21 Jan 2006 in 2005.

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
High
Ireland Singapore U.K. Australia

•180,000 Engineering graduates per annum!

Location Attractiveness  Infrastructure  Country-specific risks  Time zone attractiveness

China

India

•70% of CMM level 5 companies are in India
Philippines

Mexico

Low Low
Note: Size of circle indicates resource availability

•185 of Fortune 500 outsource IT services to India

High People Strength  Skills quality  Resource costs  Language abilities and other skills

Source: NASSCOM – McKinsey. 2002
21 Jan 2006

CDM Process
STUDY CENTERS DATA ENTERED INTO ORACLE DATABASE LOGICAL CHECKS IN ORACLE RUN INVESTIGATOR ANSWERS QUERY FAXED TO HIM AFTER FREEZING BIOSTATICIANS DO ANALYSIS

DATA PAPER CRF FROM SITES/HOSPITALS SENT TO SCAN

ENTERED DATA CLEANED/VALIDATED

BOTH AUTOMATED VALIDATIONS AND MANUAL DISCREPANCY RESOLVED

FREEZING OF DATABASE AFTER ALL DATA IS CLEAN

FINAL ANALYSIS DONE FOR SAFETY AND EFFICACY

CDM Process
Subject

CRF DCF Investigator Sample Lab Results Monitor CRF DCF Clinical Data Regulatory Authority Clinician
21 Jan 2006

Statistician NDA

Central Laboratory

Data Manager

Core CDM Processes

DATA ACQUISITION
 

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

DATA STORAGE
  

Core CDM Processes

DATA PROCESSING
   

Forms Processing Data Entry Coding Cleaning (manual clinical review & programmatic checks) Design of Data Validation Strategy Specification of Design

DATA VALIDATION
 

Core CDM Processes

LAB, SAFETY REPORTING & OTHER EXTERNAL DATA
 

Data Transfers & Loads Database Reconciliation Auditing Quality Control Procedure Statistical Sampling Quantification of Database Quality

DATA QUALITY
   

Core CDM Processes

DATABASE CLOSURE
  

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

VENDOR MANAGEMENT
 

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

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

Head Clinical Data Management and Biometrics
DATA MANAGEMENT
Head Data Management

QUALITY SYSTEMS
Head Quality

BIOSTATISTICS
Head Biostatistics

Project Team Leads

IT Services
Applications Administrator

DM Lead Data reviewer Coding & Safety Review Report auditor

QA Lead SOP’s Develo per Validator

Project Team Leads

Lead Data Coordinator s Senior Data Coordinators Data Coordinators Medical Coding Data Entry Associate II s Data Entry Associate I s

Sr. Statisticians Statisticians

Applications Developer

Trainer Statistical Programmer

CRF designer

Hardware Engineer

Safety Reporting

21 Jan 2006

OTHER PLAYERS ASSISTING CDM PERSONNEL IN CLINICAL RESEARCH

Code of Ethics for CDM Professionals
Clinical 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

Sign up to vote on this title
UsefulNot useful

Master Your Semester with Scribd & The New York Times

Special offer for students: Only $4.99/month.

Master Your Semester with a Special Offer from Scribd & The New York Times

Cancel anytime.