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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