Managing Vendor/CRO/CMO Oversight in the Pharma Industry

With this In-house training your tream will 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. Also covered will be the techniques for successfully managing CROs/vendors and the shared responsibilities required by the sponsor and the service provider.

In-house Training Services and Consultancy

This In-house workshop is designed for sponsoring pharma companies who are outscourcing critical practices to improve efficiency and productivity. It will help your team to understand how to effectively manage CROs/Vendors used in the pharma industry and show them how to build an understanding of the organisations responsibilities as a sponsor. It shows how to focus on oversight preparation, planning and how to clarify roles and responsibilities. Most importantly it details how to measure CRO performance including metrics and key performance indicators.

Your next step is to call us now on +44 (0)20 7729 6677 or email us at info@falconbury.co.uk or use our contact form and find out how we can help. There are no commitments, and if we cannot help our advice and recommendations are free of charge.

Sample programme

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 oversight

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 v 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 Responsibilities

  • 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 solutions

End of project oversight: Reviewing CROs during and at the end of the project

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

Recommended trainer

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical Research at the University of Cardiff, and MSc Regulatory Affairs, TOPRA. She has more than 19 years experience in the pharmaceutical industry and has worked for several companies, including GlaxoWellcome, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in Drug Development, Clinical Research, Quality Assurance and Marketing. She has a particular expertise in Clinical Research and GCP issues. She was Chairman of the ACRPI GCP Forum for six years. She regularly writes on clinical research issues and ICH GCP, is author of SCRIP’s GCP guide and is a member of the editorial board of the Board of the Good Clinical Practice Journal. She is co-author of several books on management including ‘Developing the Individual’, ‘The Ultimate Book of Business Skills’ and ‘Pharmaceutical Project Management’.