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
With regulatory inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming even more important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. A company’s ability to identify and select the right CRO/ vendor for the right project and manage them efficiently and effectively will help to ensure compliance with the regulator’s expectations.
On this course, you 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. You will also cover the techniques for successfully managing CROs/ vendors and the shared responsibilities required by the sponsor and the service provider. Managing CRO performance issues will also be discussed.
The course is equally useful to CROs/other vendors and consultants to understand how to work effectively with sponsor organisations.
Benefits of attending:
- Understand how to effectively manage CROs/vendors used in the pharma industry
- Build an understanding of your responsibilities as the sponsor and identify the right level of management and oversight
- Discuss how to put in place a robust CRO/vendor selection process
- Discover tools and processes to manage CROs and other vendors
- Measure CRO performance including metrics and key performance indicators (KPIs)
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 for outsourcing in 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 vs 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 an 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
Ongoing oversight and management
- Tracking and measuring CRO progress and performance
- Ongoing 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 learnings for using the CRO in the future
Dr Laura Brown,
Pharmaceutical QA and Training Consultant ,
University of Cardiff
Dr Laura Brown MBA, BSc,PhD, is a Pharmaceutical QA and Training Consultant, Course Director for the MSc in Clinical Research, School of Pharmacy at the University of Cardiff. She has more than 20 years’ experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSKs Hoechst Marion Roussel, Farmitalia and Phoenix International. She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including “The Planning of International Drug Development”, in the Clinical Research Manual, Euromed and the “Impact of Brexit”, RQA Journal 2017.
This event is designed for personnel involved in CRO/vendor oversight in the pharmaceutical, biotechnology, animal health and medical device industries including those working in clinical research, regulatory affairs, pharmacovigilance, manufacturing, clinical outsourcing, contracts, quality, clinical operations, vendor management and global QA/compliance. It will also be relevant for outsourcing, purchasing, finance and contract management staff who participate in the RFP process who will find this course a valuable introduction or refresher course focusing on best practice.
This course will also help CRO/vendor personnel to work more successfully with pharmaceutical, biotechnology and medical device companies through gaining a much clearer understanding of their needs when outsourcing.
11 Thurloe Pl,
The Rembrandt Hotel is located at 11 Thurloe Place, London, SW7 2RS. The hotel’s location in central London couldn’t be better, whether you’re travelling for business or leisure. You’ll be right between two of London’s most fashionable areas – South Kensington and Knightsbridge – within walking distance of museums, theatres, Harrods and Hyde Park.
You can hop on the Tube at South Kensington and take the District, Circle or Piccadilly lines direct to the City of London, Heathrow Airport and all other areas of the city. Look out of your window and you may well see the Victoria and Albert Museum – it’s right across the street.