CRO Management & Selection_Corporate

COURSE DETAILS

Customisable In House Training

Attractive Cost Savings     

 

Enquire Today For A Free Training Plan For Your Organisation

 

Back to Course Listing

 

THE PROGRAM

This intensive workshop will cover the ways of identifying, selecting, contracting and working with a CRO partner. Details like how to develop an Initial Request For Information (RFI), designing an activity based Request for Proposal (RFP), Budget Formats, conducting a Pre-qualification process will be discussed, as well as the Contractual elements of the partnership like the Master Service Agreement, Quality Agreement, Scope and Budget Obligation. On the second day, full focus will be on the management of the CRO, with topics like how to develop a project specific training, apply Project Management and Risk Management to Sponsor CRO relationship, as well as what to do when replacing a CRO during an on-going project.


It is an ideal workshop for manager who sub-contract studies to CROs, and who wants a complete view. The course will provide a combination of training on theory and application of theory through group exercises.

 

COURSE OBJECTIVE

  • Define the steps to identify and access potential CRO vendors
  • Define the differences between a Request for Information (RFI) and a Request for Proposal (RFP)
  • Define the content of an RFI and RFP
  • Design an activity-based budget template
  • Define best practices in pre-qualifying vendors
  • Define and differentiate between Master Service Agreement, Statement of Work and Confidential Disclosure Agreement
  • Define the steps and processes for managing a CRO once a contract is executed
  • Describe conflict resolution concepts
  • Define and develop a Corrective and Preventative Action Plan (CAPA)
  • Define the principals of risk assessment/management
  • Demonstrate a sample risk assessment/management process

 

WHO SHOULD JOIN

  • Managers who sub-contract studies to CROs
  • Personnel working with CROs
  • Clinical Research Coordinators/Associates
  • Clinical Research professionals
  • Clinical Scientist / Basic Scientist
  • Clinical Investigators / Principal Investigators
  • Experienced Clinical Quality Assurance Professionals
  • Project Managers
  • Clinical Study Coordinators