CRO Selection and Monitoring Short Course Overview

Introduction

Overview On CROs

      •    Mega-CROs  -  Who are they and what services do they provide?

      •    Niche Providers  -  Do the specialists offered the needed services?

Common Outsourcing Strategies

        •    Virtual Company  -  Offering everything for everybody?

        •    Pre-selected  -  Qualified and guaranteed availability?

        •    Special Study  -  A "pair of hands" for one or two studies?

Sponsor Items To Be Accomplished Before Contacting CROs

       •    Drug Discovery Or Drug Development Plan

       •    Overall Outsourcing Program

       •    Responsibilities and Accountabilities

       •    Specific Study Designs

       •    CRO Review For Research Studies To Be Outsourced

CRO Selection Process

        •    First Contact With CROs

        •    Study Design(s) Submission

        •    Proposal Review and Evaluation

        •    Site Visits and What Should Be Evaluated

        •    Contract Negotiation and Award

CRO Monitoring Process

        •    Study Set-up, Including Necessary Supplies

        •    Critical Phase Monitoring

        •    Frequency

        •    Critical Stages

        •    Support Laboratories

        •    Problem Assessment and Correction

Study Report

        •    Data Review and Interpretation

        •    Draft Report Review and Correction

        •    Study Audit

        •    Final Report

Summary and Conclusion