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Clinical HOV Lane Standards
Dr. Rao TekiPrincipal, Healthcare Solutions, HCL
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Clinical HOV Lane Standards
• Let’s start with you …– How many of you have worked on PhaseForward
(Oracle) ClinTrial, InForm or other ASP model Applications
• Me …– 14 years of international experience as a Physician– 11 years of Global clinical research experience
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Clinical HOV Lane Standards
Clin-ical38%
Non Clinical20%Regu-
latory4%
Others11%
Dis-covery27%
Phase I18%
Phase II & III66%
Phase IV16%
Clinical Trial Costs
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Clinical HOV Lane Standards
Starting point Destination
FDA Guidelines>Developed
the standards
We do not have the standards
Pre Study
Activities Study Conduct and Close out Submission
FPFV
Monitoring
Time TimeLPLV
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• What is Today’s Date?– 4/12/2011– 12/4/2011– April 12, 2011– Tuesday April 12, 2011
Clinical HOV Lane Standards
• CRF Date Format:
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Clinical HOV Lane Standards
The Standards for United Clinical World
Standards : • Global Standards – Investigators and Sites • Subject recruitment
Pre Study
Activities Study Conduct and Close out Submission
FPFV
Monitoring
Time TimeLPLV
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Pistoia Global standards for Investigators & Sites
Physician Office
SPONSORS and CROs
Hospital
Regulators
Continuing Clinical Research Education Program (CCREP)
Periodic Training
GCP Training and Certification. Prepare the PI for Global Study.
Pistoia Certified PI
Access to Pistoia Certified Sites and Investigators
Industry related updates
Regulatory Guidelines
GCP Training and Certification. Prepare the Site for Global Study.
Pistoia Certified Site
Pistoia Global Standards for Sites and Investigators
United Clinical World
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Pistoia Certified Sites and Investigators
Advantages:Pistoia Global Standards Certified Sites and InvestigatorsFaster Study Initiation and reduced trial time and cost ($$)Distribution Globally - country or regional level sites Selection of best sites (w/ adequate infrastructure) &
investigators, Based on their specific patient populations, Past clinical trial experience, currently availablePersonnel, and affiliations to other physicians and hospitals
Improved subject enrollment and monitoringUnified view of investigator and HCP dataImproved knowledge of investigator/HCP status and changes –
qualificationsEfficient process to handle increasing FDA audits and inspections
of trials sitesImproved report monitoring quality for study managers
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Questions
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Clinical HOV Lane Standards
Thank you
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