Managing CDM Team Growth
Kelly Ritch, M.S.
Assistant Director
Department of Clinical Data Management
Rho, Inc.
100 Eastowne Drive
Chapel Hill, NC 27713
CDM Evolution
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Past
Everyone did
everything
Data processed as
completed subjects
Financially closely
tied to client
Large trials meant
large CROs
Why evolve?
1. Desire to win more & bigger trials
2. Too much pressure on a small number of people
to be perfect. Easier when studies were
complete-later slides discuss never real time
demands on DM. Requires group working
interdependently, checks and balances.
3. More clients means more financial stability,
more compartmentalized can handle more work
if it runs in two.
Clinical Data Leadership vs.
Clinical Data Management
• Improves the incoming information come in
process rather than managing an existing process
end point.
• Improves the data rather than just keeping the data
status of the information we are holding
• Creates proactive/partnership role rather than
reactive/passive role
Are these the “right” m&m’s?
Why evolve? Revisited
1. Meet demand for high quality
2. Interaction required with diverse
personnel
3. Pieces & Parts
4. Increasing scopes require flexibility
5. Decisions save $$
6.Future Relationship
CDM Evolution
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•
•
•
Past
Everyone did
everything
Data processed as
completed subjects
Financially closely
tied to client
Large trials meant
large CROs
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•
•
•
Present & Future
Each person has a
roles
Data is processed in
small pieces
Diversity within and
between clients
Large trials done by
well run team
Creating the CDL Team
Roles
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Document Management
Database Development & Setup
Development of logic checks, program & report specs
Query Problem-solving
Organizing study materials
Quality control
Final Decision Maker/Communicator
Creating the CDL team
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Skills
Communication
Meticulous review &
organization
Terminology &
therapeutic familiarity
Aptitude for logic &
problem-solving
Ability to distribute
Final decision
responsibility
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Backgrounds
Clinical
Math
English
Customer Service
Sales
Project Management
History
Remember this…
• Know the roles you need.
• Know what skills are necessary for each
role
• Need well running teams in order to meet
future real-time demands