Informa Australia is part of the Informa Connect Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Choose Location

27-09-2022 (Live Online Training)

Customise Group Training

Comments

Live Online Training:
CRO Contracting, Oversight & Budget Negotiations

CRO Contracting Models, Selection, RFP, Performance Oversights and Budgeting

LIVE ONLINE TRAINING | 4-Part series | Over 4 days
24-27 May 2022 | 14:00 – 18:00 (AEST)
27-30 September 2022 | 14:00 – 18:00 (AEST)

Book Now Customise Group Training Call me back Download Brochure

overview

Key Learning Outcomes

  • Understand the different types of CRO contracting models
  • Discover the right tools to evaluate and select CROs
  • Identify GCP and budget requirements
  • Learn how to prepare an effective Request for Proposal (RFP)
  • Measure CRO performance using metrics and KPI’s
  • Communication and relationship management for CRO/Sponsor
  • Develop a strategic approach in dealing with changes in scope in an on-going project

About the Course

Most pharma, biotech and device companies outsource some or all of their clinical trial programmes to one or more CROs. The differences in operations and project management of a study between in-house and through a CRO are considerable and may cause significant challenges to clinical executives when transitioning to CRO-run project management. In addition, the latest revision to ICH GCP has highlighted the responsibility on the Sponsor to oversee their trials. Agency Inspectors are increasingly focusing on this as an area of weakness in Sponsor companies.

This intensive masterclass aims to provide participants thorough understanding on selection and oversight of CRO. Gain practical solutions on how to better design & implement RFP (request for proposal), bid evaluation, CRO selection and oversee your project to conclusion. Participants will also learn how to deal with on-going changes in the project, CRO/Sponsor partnership optimisation and how to design an effective communication plan. The restrictions caused by Covid-19 as well as implications on CRO oversight & communications will also be discussed throughout the course.

Who Will Benefit

  • Clinical Outsourcing
  • Clinical Operations
  • Project Management
  • Contract Management
  • Clinical Quality Control
  • Finance / Purchasing/ Project Controlling
  • Medical Affairs
  • Procurement / Purchasing
  • Strategic Sourcing
  • Program/Portfolio Management
  • CRO Administration and Management

trainer

Peter Motteram

Director – ProActive Study Management

pricing

Packages Price
Live Online Training 2022$2995+GST

Great Savings:
When you book 4 or more participants! Call us today on +61 (0) 2 9080 4395 or email training@informa.com.au to take advantage of the discount offer.

Live Online Training

Learn Anywhere, Learn Anytime
Catering to meet all your learning needs:

  • Get high quality practical training from our expert instructors
  • From Face To Face, Online and Blended Learning, get a superior solution for your learning needs
  • Learn live online in an interactive environment
  • Invest in yourself. Invest in your team.

Register today for our Live Online Training courses and find out how they can help you transform the way you work. Contact one of our training consultants on sgtraining@informa.com to find out more.

View Live Online Training Brochure

Testimonials

“Instructor was candid and gave real world examples, he gave constructive feedback on exercises, group discussions generated a lot of interesting discussion and debate”
Clinical Project Manager, Tessa Therapeutics

“Lot of examples shared by others’ mistakes, different tools/options to consider in project managing & oversight. Trainer offers project management from a different perspective; as well as strategies for measuring, reporting, controlling, resource prediction among other things”
Director – Project Management, Clinipace

Course Outline

MODULE 1

SPONSOR PERSPECTIVE OVERVIEW

  • Regulatory expectations
  • Business expectations
  • Project Management of the CRO

OVERVIEW OF WORKING WITH A CRO

  • Current CRO business model
  • Types of Contracting Models
  • Contract versus project management
  • Overview of CRO Management Steps
    • RFP
    • Contract
    • Oversight
    • Change in Budget and/or Scope

MODULE 2

OVERSIGHT

  • Knowing the status and health of your project
  • Measurements, KPI’s, reports,
  • Documenting CRO tasks and responsibilities
  • Vendor oversight plan

SPONSOR/VENDOR COMMUNICATION

  • CRO Meetings
  • Effective communication plan
  • Mode of communication
  • Feedback and resolution

CRO QUALIFICATION ANALYSIS

  • Criteria during selection phase
  • Elements of a contract
    • Fees – how to review the budget
    • Use of a standardised bid grid
    • Services
    • Legal
  • Evaluation of different selection tools
    • Bid defence meeting
    • Qualification visit or audit
    • Standardised questionnaire
  • Negotiating contracts with CROs – key considerations
    • Sponsor’s responsibilities
    • CRO’s responsibilities

MODULE 3

DEVELOPING REQUEST FOR PROPOSAL (RFP)

  • Basic elements
  • How your selection criteria, anticipated relationship and oversight affect your RFP
  • Use of feasibility studies

ON-GOING CHANGES IN THE PROJECT

  • Dealing with changes in scope and/or requests for more resource
  • Budget tracking and renegotiation

MODULE 4

TYPES OF SPONSOR CRO RELATIONSHIP

  • Preferred provider model
  • Single provider model
  • Relative size of Sponsor and CRO

BUDGET STRUCTURING, FORECASTING, NEGOTIATION AND COMPLIANCE

  • GCP guidelines, regulations, applicable law and best practices
  • Structure for CRO-run projects’ budgets
  • CRO budget forecasting, negotiation and tracking
  • Billing and payment issues with CROs

CASE STUDIES THROUGHOUT

Dedicated Exercises and Case Studies on:

  • Setting CRO charge-out rate
  • Making CRO reports a tool to help you manage
  • Worked example of drafting a vendor oversight plan
  • Analysing a CRO budget
  • Developing a CRO selection grid and setting objective choice criteria
  • Creating an RFP

when & where

24 - 27 May 2022

Live Online Training

27 - 30 Sep 2022

Live Online Training

On-site & in-house training

Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?

Talk to us about an on-site/in-house & customised solution.

contact

Still have a question?

Sushil Kunwar
Training Consultant
+61 (0)2 9080 4395
training@informa.com.au

Get all the latest on Informa news and events

Informa Connect Australia is the nation's leading event organiser. Our events comprise of large scale exhibitions, industry conferences and highly specialised corporate training.

Find out more

COVID-19  Cancellation  Policy
Read  Policy  Terms
close-image