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Managing Vendor/CRO Oversight for Clinical Trials

With regulatory inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming increasingly important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities in the to ensure for successful vendor selection, contract considerations, and oversight of CROs to ensure compliance with the expectations of inspections for running clinical trials. Participants will learn how to prepare a Request for Proposal (RFP) and use that to find, evaluate and select the right CRO for the clinical studies they need to outsource. This course will also cover the techniques for successfully managing CROs and the shared responsibilities required by the sponsor and the service provider. Managing CRO performance issues will also be be discussed.

Turning 'Theory' into 'Practice'?

This interactive course will build upon the foundations of CRO management methodology, technical tools and techniques and develop the essential skills that are critical for ensuring the success of your business. This course will enable you to apply practical CRO management techniques to your own pharmaceutical projects. Our CRO management training will be interactive and applicable to your daily work. Participants are encouraged to bring a current real cases to the course to which they can apply the concepts and techniques, thus reaping the benefits immediately and enhancing the learning experience.

Who should attend?

This course is designed for personnel involved in vendor/CRO oversight (including those working in Clinical Research, Regulatory Affairs, Clinical Outsourcing, Contracts and Outsorucing, Clinical Quality Assurance, Clinical; Quality Control, Clinical Operations, Vendor

Key areas to be covered in the programme and documentation

Background to the CRO industry and meeting regulatory expectations
• Outsourcing today for clinical trials
• Different models of outsourcing clinical trials
• The potential benefits and drivers of outsourcing
• Examine EU and FDA expectations re outsourcing for clinical trials

Group Discussion: Working effectively with CROs
Challenges of working with CROs to ensure effective management

CRO selection: An overview of selection and bidding processes including assessing the competency the CRO to run a clinical trial
• 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
• Contract negotiations and partnering with CROs

Managing CROs set up for clinical trials
• 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 and maintain quality of the Quality
• Briefing the CRO to be able to successfully run clinical trials
• Clarity of roles and responsibilities

Preparation, planning and clarity of roles and responsibilities with CROs
• Project set-up, planning and initiation with CROs for the clinical trial
• 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 they can set up in order to manage regular meetings(eg weekly/biweekly or as required) with CROs for the clinical studies

On-going Management of CRO continued
• Tracking and measuring CRO progress and performance
• On-going training and integrating new CRO staff
• Auditing CROs for running the clinical trial activities
• Maintaining effective communication with the CRO
– Progress and update meetings/TCs with CROs
– Agendas for meetings with CROs Update reports and reporting progress of CROs
– Discussion of billing issues with CROs, and time to reconcile the invoiced hours vs the actual number of hours by the CROs
– Deliverables and analysing performance trends

Troubleshooting problems with CROs
• Common problems and possible solutions to be discussed in clinical
trials where CROs are used

Review of CROs during and at the end of the clinical study
• Review meeting

Benefits to you

• Understanding how to effectively manage CROs/Vendors used in clinical trials
• Build an understanding of your responsibilities as the sponsor: identifying the right level of management and oversight
• Using a robust CRO/Vendor selection process for clinical studies
• Understanding tools and processes to manage CROs
• Measuring CRO performance including metrics and key performance indicators
• Sharing experiences and lessons learned from other pharmaceutical professionals managing CROs running clinical trials

Companies already benefiting include:

Duration of Course

2 Day Course

Course details

This course is currently only available as an in-house option. For more information, and a quote, contact our team on +44 (0)20 3002 3057, or by email at ProfessionalTraining@iihc.org

Looking to train larger teams in this subject?

dzingim@marcusevansuk.comTailored in-house/in-company training courses and bespoke strategy workshops designed and delivered on-site throughout Europe according to your specific requirements.

All management, personal development and project management public courses featured in our Course Directory are also delivered on an In-Company basis.

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Further information

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or dzingim@marcusevansuk.com

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dzingim@marcusevansuk.com - Marketing Manager EMEA - Professional Training


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Testimonials

"This course will allow my company to develop its existing strategies to a much greater and hopefully profitable level."

Managing Director, Tarmac