Comparator sourcing is a fast-growing industry in clinical trials that has doubled within the last five years. As most drug candidates are being studied against the existing standard of care (comparator), the need for secure and transparent sourcing of comparator drugs and non-investigational medicinal products (NIMPs) on a global scale is likely to rise significantly.
However, this is a very complex process and designing an efficient and agile supply chain is challenging. Often poorly designed supply chains result in tremendous wastage and even worse, lack of medication at the site might delay studies and put patients at risk.
There are many important questions to be addressed upfront; extensive planning and pharmaceutical supply knowledge on a global scale is required.
In this webinar, our speaker will provide a comprehensive overview of the complexities and challenges of sourcing comparators while addressing protocol requirements. She will also provide expert science-based advice on bespoke solutions for successful comparator sourcing.
Speaker
Dr. Vanessa Dekou, Managing Director, Clinical Services International (CSI)
Vanessa has extensive experience in drug development from preclinical to registration and commercialization strategies and has secured product registration for several orphans and first-in-class drugs.
She has successfully designed and executed numerous trials all over the world. As such, Vanessa understands all the challenges and requirements of supplying comparators to clinical trials and ensuring trials are delivered on time and on budget. Vanessa has worked with some of the largest biopharmaceutical and biotechs to provide innovative solutions.
At CSI, Vanessa is responsible for providing bespoke solutions to their clients to ensure comparator sourcing is not a rate-limiting step in the successful delivery of trials.
She also works closely with pharmaceutical manufacturers to safeguard the supply chain and remain on the front line of advances in drug development.
Vanessa has a PhD in Cardiovascular Genetics from UCL, an MBA from Cambridge and a Masters in Market Access from University of Lyon.
Message PresenterWho Should Attend?
This webinar will benefit clinical teams, plus professionals in clinical supplies, logistics and outsourcing, and project management, including those working within:
- Clinical Supply Team
- Comparator Sourcing Team
- Clinical Project Management
- Clinical Management
- Procurement Team
- Clinical Trial Team
- Supply Chain Department (CRO)
- Clinical Development
- Investigator Sites
- Clinical Operations
- Clinical Supplies & Investigational Supplies
- Clinical Packaging
- Clinical Labelling
- Clinical Quality Assurance/Quality Control
- Regulatory Affairs
What You Will Learn
Topics to be covered include:
- What is a comparator?
- Why using comparators in study designs?
- Options for comparators sourcing
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- Central sourcing
- Local Sourcing
- Hybrid Model
- Roadmap to successful comparator sourcing
Xtalks Partner
Clinical Services International (CSI)
Clinical Services International (CSI) is a global leader in sourcing and management of commercially-available medicines and comparators for clinical trials. Headquartered in London and with operations in UK, Germany and the USA, we provide efficient solutions and serve worldwide trials. Our longstanding experience and relationships with manufacturers enables us to provide custom-made solutions to address the most complex requirements.
Our USP:
We are scientist and have all worked in drug development, so we understand protocols and challenges and comparator sourcing is a value-added science-based approach rather than a commodity.
- Accelerate drug development and reduce timelines by providing a fully integrated service
- Address regulatory, quality, operational, clinical requirements
- Manage the entire supply chain and offer tailor-made solutions
- Comprehensive expertise in oncology and biosimilar products.
- Advanced technology and innovative approach
- Trusted partner of leading biopharmaceutical companies, CROs and CMOs
Experience and Expertise
- 25+ Years’ Experience in Drug Development and Clinical Trial Supplies
- Worldwide Access:
- Sourcing In Europe, USA, Latin America And Asia Pacific
- Relationships with 95+ Manufacturers:
- We Work Directly with All Big Pharmaceuticals And Generic Manufacturers
- Science Underpins Our Approach To Comparator Sourcing
- Operationally excellent
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