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 Teki of HCL.

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HCL -- Clinical HOV Lane Standards

  1. 1. Clinical HOV Lane Standards<br />Dr. Rao Teki<br />Principal, Healthcare Solutions, HCL<br />
  2. 2. Clinical HOV Lane Standards<br />Let’s start with you …<br />How many of you have worked on PhaseForward (Oracle) ClinTrial, InForm or other ASP model Applications<br /><ul><li>Me …</li></ul>14 years of international experience as a Physician<br />11 years of Global clinical research experience<br />
  3. 3. Clinical HOV Lane Standards<br />Clinical Trial Costs<br />
  4. 4. Clinical HOV Lane Standards<br />Pre Study Activities <br />Study Conduct and Close out<br />Submission<br />Destination<br />Starting point<br />FDA Guidelines>Developed the standards<br />We do not have the standards<br />Monitoring<br />Time<br />LPLV<br />FPFV<br />Time<br />
  5. 5. What is Today’s Date?<br />4/12/2011<br />12/4/2011<br />April 12, 2011<br />Tuesday April 12, 2011<br />Clinical HOV Lane Standards<br /><ul><li>CRF Date Format:</li></li></ul><li>Clinical HOV Lane Standards<br />Pre Study Activities <br />Study Conduct and Close out<br />Submission<br />The Standards for United Clinical World<br />Standards : <br /><ul><li>Global Standards – Investigators and Sites
  6. 6. Subject recruitment</li></ul>Monitoring<br />Time<br />LPLV<br />FPFV<br />Time<br />
  7. 7. Physician Office<br />Regulatory Guidelines<br />Industry related updates<br />GCP Training and Certification. Prepare the Site for Global Study. Pistoia Certified Site<br />Continuing Clinical Research Education Program (CCREP)<br />Periodic Training<br />Access to Pistoia Certified Sites and Investigators<br />SPONSORS and CROs<br />GCP Training and Certification. Prepare the PI for Global Study. Pistoia Certified PI<br />Pistoia Global standards for Investigators & Sites<br />Hospital <br />Regulators<br />Pistoia Global Standards for Sitesand Investigators<br />United Clinical World<br />
  8. 8. Pistoia Certified Sites and Investigators<br />Advantages:<br />Pistoia Global Standards Certified Sites and Investigators<br />Faster Study Initiation and reduced trial time and cost ($$)<br />Distribution Globally - country or regional level sites <br />Selection of best sites (w/ adequate infrastructure) & investigators, <br />Based on their specific patient populations, <br />Past clinical trial experience, currently available<br />Personnel, and affiliations to other physicians and hospitals<br />Improved subject enrollment and monitoring<br />Unified view of investigator and HCP data<br />Improved knowledge of investigator/HCP status and changes – qualifications<br />Efficient process to handle increasing FDA audits and inspections of trials sites<br />Improved report monitoring quality for study managers<br />
  9. 9. Questions <br />
  10. 10. Clinical HOV Lane Standards<br />Thank you<br />

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