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HCL -- Clinical HOV Lane Standards
 

HCL -- Clinical HOV Lane Standards

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The Pistoia Alliance Conference in April 2011 included a series of 10-minute "lightning talks" from vendors about what they think pharma will look like in 2020. This presentation was delivered by Rao ...

The Pistoia Alliance Conference in April 2011 included a series of 10-minute "lightning talks" from vendors about what they think pharma will look like in 2020. This presentation was delivered by Rao Teki of HCL.

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    HCL -- Clinical HOV Lane Standards HCL -- Clinical HOV Lane Standards Presentation Transcript

    • Clinical HOV Lane Standards
      Dr. Rao Teki
      Principal, Healthcare Solutions, HCL
    • 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
    • Clinical HOV Lane Standards
      Clinical Trial Costs
    • Clinical HOV Lane Standards
      Pre Study Activities
      Study Conduct and Close out
      Submission
      Destination
      Starting point
      FDA Guidelines>Developed the standards
      We do not have the standards
      Monitoring
      Time
      LPLV
      FPFV
      Time
    • 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:
    • Clinical HOV Lane Standards
      Pre Study Activities
      Study Conduct and Close out
      Submission
      The Standards for United Clinical World
      Standards :
      • Global Standards – Investigators and Sites
      • Subject recruitment
      Monitoring
      Time
      LPLV
      FPFV
      Time
    • Physician Office
      Regulatory Guidelines
      Industry related updates
      GCP Training and Certification. Prepare the Site for Global Study. Pistoia Certified Site
      Continuing Clinical Research Education Program (CCREP)
      Periodic Training
      Access to Pistoia Certified Sites and Investigators
      SPONSORS and CROs
      GCP Training and Certification. Prepare the PI for Global Study. Pistoia Certified PI
      Pistoia Global standards for Investigators & Sites
      Hospital
      Regulators
      Pistoia Global Standards for Sitesand Investigators
      United Clinical World
    • Pistoia Certified Sites and Investigators
      Advantages:
      Pistoia Global Standards Certified Sites and Investigators
      Faster 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 available
      Personnel, and affiliations to other physicians and hospitals
      Improved subject enrollment and monitoring
      Unified view of investigator and HCP data
      Improved knowledge of investigator/HCP status and changes – qualifications
      Efficient process to handle increasing FDA audits and inspections of trials sites
      Improved report monitoring quality for study managers
    • Questions
    • Clinical HOV Lane Standards
      Thank you