Market Overview

2 Day Workshop: Managing Vendor/CRO/CMO Oversight -


The "Managing
Vendor/CRO/CMO Oversight"
conference has been added to's

Learn how to prepare a Request for Proposal (RFP), evaluate and select
the right CRO and establish procedures for vendor oversight for R&D
projects you need to outsource.

This workshop is specifically designed for sponsoring pharma companies
who are outsourcing critical practices to improve productivity. It will
help you get to grips with effective CROs/Vendors management used in the
pharma industry and your responsibilities as the sponsor. It will also
show you how to clarify roles and responsibilities, focus on oversight
preparation and planning. Most importantly it offers an in-depth insight
into CRO performance measurement including metrics and key performance


Introduction and Objectives

Background to the CRO Industry and Meeting Regulatory Expectations

  • Outsourcing today for the Pharma industry
  • Different models of outsourcing in the Pharma industry
  • The potential benefits and drivers of outsourcing
  • Examine EU and FDA expectations re. outsourcing for the Pharma industry

Effective Oversight: How CROs and Sponsors can Work Successfully on R &
D Projects

  • Challenges of working with CROs to ensure effective management and

Vendor/CRO Selection - an Overview of Selection and Bidding Processes
including Assessing the Competency of the CRO / Vendor

  • All or none - what should you outsource?
  • Sponsor responsibilities for the clinical study vs the CRO
  • Writing the RFP
  • Evaluating responses to the RFP
  • Pre-qualification of vendors and vendor audits
  • Contracts, negotiations and partnering with CROs

Managing Vendor/CRO Project Set Up

  • Building effective relationship with the CRO while providing sponsor
    oversight and a working escalation of issues
  • How to set the stage so the CRO focuses on Quality - the
    quality/oversight plan
  • Briefing the CRO to be able to work successfully in the Pharma industry
  • Clarity of roles and responsibilities

Oversight Preparation, Planning, and Clarity of Roles and

  • Project set-up, planning and initiation with CROs for R & D projects
  • Training CROs
  • Which SOPs should CROs use?
  • Clarity and communications with CROs
  • Risk assessment tools
  • Tools and techniques for managing CRO performance - understand the
    KPIs / dashboards / report processes that can be set up in order to
    manage regular meetings with CROs / Vendors

On-Going Oversight and Management

  • Tracking and measuring CRO progress and performance
  • On-going training and integrating new CRO staff
  • Auditing CROs
  • Maintaining effective communication with your CRO
  • Progress and update meetings / TCs with CROs
  • Agendas for meetings with CROs to include update reports
  • Discussion of billing issues with CROs
  • Deliverables and analysing performance trends
  • Troubleshooting problems with CROs - Common problems and possible

End of Project Oversight: Reviewing CROs during and at the end of the

  • Review meetings
  • Feedback and learning's for using the CRO in the future

Review and Final Discussion

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