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.
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.
Background to the CRO industry and meeting regulatory expectations
Effective oversight: How CROs and sponsors can Work Successfully on R&D projects
Vendor/CRO selection – an overview of selection and bidding processes including assessing the competency of the CRO/Vendor
Managing Vendor/CRO Project Set Up
Oversight Preparation, Planning and Clarity of Roles and Responsibilities
On-going oversight and management
End of project oversight: Reviewing CROs during and at the end of the project
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’.
We don't have any currently scheduled dates for this course but we can customise it to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.
Contact our in-house training expert Aleksandra Beer to discuss your requirements: