Do you want to know more about how to overcome challenges and pitfalls when outsourcing your clinical studies?
Claudia Blomgren-Hansen from LIFE SCIENCE PLUS Advokater and Rikke Winther from WIN Outsourcing Consult will share insights and best practices that work.
Conducting the required clinical studies as part of your development package is a complex, time-consuming and costly affair. Whether you are a small biotech or a mid-size pharma company, when you consider outsourcing your clinical studies, you need to be prepared that you will have to handle a multitude of disciplines that go beyond study design and study conduct.
It starts with scouting the CROs/vendor market for qualified providers and preparing request for proposals (RFP). You will have to perform a thorough analysis of CRO proposals and costs, assessing CRO capabilities, staff turnover and quality of work and finally leading to time-consuming bid-defense meetings and negotiations of CRO service agreements and clinical trial agreements with investigators. You will experience that clinical outsourcing adds additional complexity as it requires continuous monitoring and managing/governing the relationships. Performing oversight, managing and evaluating CRO performance, ensuring payments are invoiced and made in accordance with the contract are examples of activities that also need to be prioritized.
In this seminar, we will share best practices when outsourcing clinical studies seen from the perspectives of clinical trial teams, business and legal functions. We will touch upon issues like:
- Insights into the outsourcing processes and timelines
- Understanding CRO service agreements, work orders and clinical trial agreements and the dynamics between those
- Overseeing CRO/vendor performance and deliveries and proactively identify issues or behaviors, which can result in quality issues, delays or budget overruns
- How to limit the need for change orders
- What to consider in order to be compliant with your Sponsor oversight obligations
- Aspects of good governance
There will be a possibility for Q&A.
Please register your attendance in the top right corner.
