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18-11-2019 (Singapore)

P40101 CRO Contracting and Oversight
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CRO Contracting and Oversight

18 – 19 November 2019, Mandarin Orchard Hotel, Singapore

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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

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

Who Should Attend

  • 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

pricing

Packages Price
2 Day TrainingSGD $3495Early Bird

Register 2 Delegates & the 3rd attends FREE!
Group rate is based on normal rate only.
For Group Registrations, email register@informa.com or call +65 6508 2401

 

  • Special Group Discount pricing is applicable to groups of 2 or more delegates from the same organisation registering for the same event, at the same time.
  • Fee stated is the discounted price PER DELEGATE. Only one discount applies – either the early bird rate OR the Special Group Discount.
  • All fees stated include luncheons, refreshments and complete set of documentation. It does not include the cost of accommodation and travel.
  • A 7% Goods & Services Tax (GST) is applicable to all Singapore based companies for Singapore venue.

Trainer

Peter Motteram CRO Contracting and Oversight | Clinical Research Project ManagementPeter Motteram
Director
ProActive Study Management

Peter Motteram is Director of ProActive Study Management with offices in both London, UK and Boston, US. He has been in the industry for over 30 years and has spent the last 18 years consulting with companies on their clinical trials strategy, project management and CRO outsourcing. He has a wide range of experience with different types of clients operating in territories around the world, including Asia.

He originally trained in biochemistry at the Universities of Birmingham and London, and after working in a London teaching hospital, he started his pharmaceutical work at Sterling Research Group as GCP Quality Assurance auditor. He moved to Quintiles, first founding their Quality Assurance department and then leading and developing their Business Development group outside US. As General Manager of ClinTrials Research, Peter had responsibility for offices in the non-Americas regions. ClinTrials Research was at that time the third largest global clinical trials CRO and was the first to do an IPO.

Since founding ProActive Study Management, a significant component of Peter’s work has been in running training courses, both public and tailored to in-house needs.

Digital Badge

Upon completion of this training course, participants will earn a digital badge.

Earners of this badge have acquired thorough practical understanding of contracting and overseeing CROs. They have examined various types of contracting models, tools and techniques to quality & select CROs, practical considerations in RFP management, KPIs for CRO performance measurement as well as skills required in dealing with on-going changes in the projects. They have also learned effective communications plan required for sponsor/CRO relationship

Skills:
CRO, contract research organisation, request for proposal, RFP, budget, management, communications, documentations, contract, oversight, timeline, clinical outsourcing, contract management, clinical operations, patient recruitment, project management, medical affairs, programme management, portfolio management, cro administration

Eligibility:
Attend and participate in the 2 full days of training course duration, led by the designated training expert

Available to:
Seminar attendees

Digital Badge FAQ >

Agenda

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

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

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

TYPES OF SPONSOR CRO RELATIONSHIP

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

CASE STUDIES THROUGHOUT

when & where

18 - 19 Nov 2019

Mandarin Orchard Singapore, by Meritus
333 Orchard Road, Singapore 238867
Tel: +65 6831 6062 | Fax: +65 6737 3130
Mobile No.: +65 8298 9442

Contact Person: Tan Ai Li
Email: aili.tan@meritushotels.com
Website: www.meritushotels.com

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.

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