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Shortening the Pre-Clinical Research Cycle at the Clinical
Discovery Laboratory
Galen ChanAnand Singhania
Fern-Anita Stalling
February 23, 2011
Agenda
• Our Understanding
• Approach
• Recommendations
• Conclusion
Clinical Discovery Laboratory (CDL)
What it does?•Facilitate clinical and applied research•Assistance with budget preparation•Assistance with PACUC protocol preparation•Assistance with execution of research and study
Organization structure•Part of Medical Discovery Unit (MDRU) but reports to both MDRU and Department of Veterinary Clinical Sciences
Clinical Discovery Laboratory (CDL)
Primary Issues•Scheduling of the study•Difficult to coordinate between the animal housing, CDL facility and investigator’s availability•Delays due to schedule conflicts result in funding loss and cancellation of studies•Opportunity cost losses when the CDL is inefficient or underutilized
Challenges•Time and resource required to scheduled a study and the causes of delays are not recorded currently•Requirements of all units (PACUC, Animal Housing, and delays caused by passage through other units are amplified at the CDL level)
Clinical Discovery Laboratory (CDL)
Causes of delays in executing a study•Delays in account set up, mainly due to prolonged contract negotiations•Animal housing schedule is dependent on account set-up•Internal CDL facility capacity and availability of CDL investigators
Pre-Clinical Research Cycle Duration
• Yellow: Sponsored Program Services (proposal submission, award management, contracting)
• Orange: Purdue Animal Care and Use Committee (approval of research activities)
• Red: Animal Housing (animal requisition, animal housing scheduling)
• Blue: CDL (assistance with budget preparation, assistance with PACUC protocol preparation, assistance with execution of study: technical support, facility and equipment, peri-operative housing)
Day 0
Day 5
Day 10
Day 15
Day 20
Day 25
Day 30
Day 35
Contract Preparation Preparation and Completion of Award Notice
PACUC Approval Process Additional Review by PACUC
Animal Requisition Form
Meet with CDL Manager Complete Work Request Form Scheduling of Study
Agenda
• Our Understanding
• Approach
• Recommendations
• Conclusion
Resources & Research
• Interviews
– Dr. Gert Breur, Director of CDL
– Dr. Harm HogenEsch, Associate Dean for Research and Graduate
– Dr. John Turek, Assistant Dean of Research
– Dr. Peter Constable, Professor & Head, Department of Veterinary Clinical Sciences - pending
– Deb Cessna, Director of Financial Affairs - pending
– Suzie Inskeep, Business Manager - pending
• Documents
– CDL Future
– Notice to Proceed and Instructions
– Purdue Clinical Discovery
– Purdue SPS Handbook
– “Shortening of the Pre-Clinical Duration”
Agenda
• Our Understanding
• Approach
• Recommendations
• Conclusion
Application of Project Management Framework
• Structural Changes
– Reorganize reporting structure
– Hire an inter-group liaison• Provide temps/interns for administrative
duties as necessary
– Begin implementation of Project Management Software
– Begin automation of processes
• Initiation
– Investigator must provide all dates that he/she is available for the study up front in documentation form
• Planning & Design
– Shared calendar accessible by all groups
• Monitor & Control
– Report on variance between days budgeted and actual days needed
Initiation
Planning & Design
Monitor & Control
Executing
Closing
Project Development Phases Recommendations
Agenda
• Our Understanding
• Approach
• Recommendations
• Conclusion
Next Steps & Conclusion
• Communication– For the study: heads of the various associated departments
must be aware and buy in to the project– For the process: better communication is needed between
the various groups that are involved in the process• Improved financial management
– Better knowledge of the process will reduce the lost time associated with scheduling and rescheduling studies
– Better control of the process will allow for more studies and create a more competitive research facility