Clinical Outsourcing Event Series: H1 2021 Review and Summary
The go-to guide for professionals in the global clinical trials space
Building on the world-renowned H1 Pharma and Biotech Event Series, Arena International is proud to announce the arrival of the second H1 Virtual Event Series 2021 Handbook.
This in-depth look into key challenges within outsourcing and operations will become the on-desk reference guide for clinical trial professionals across the industry. We’ve summarized the comprehensive research and experience of leading experts in the clinical trial space to provide a manual that serves as a international roadmap for clinical trial optimization and operations while maintaining the latest regulatory compliance.
This is particularly important with the changes and challenges introduced during Covid-19, which has limited face-to-face updates.
With industry written articles and advice from leaders and peers, this handbook will also include a comprehensive supplier directory to give readers an efficient route to vendors for all of their outsourcing needs.
Key Content Areas
The H1 Virtual Event Series 2021 Handbook begins by looking into the regulatory approval for outsourcing and clinical operations, followed by information on the changing supply chain for specific clinical trials and key implications to trials and vaccinations due to Covid-19. It will also take an in-depth look at CRO Partnership and Development.
Chapter 1 Features: Outsourcing and Clinical Operations
• What is required for a drug to be approved under the LPAD pathway?
• The Evolving Supply Chain for Stem Cell Therapy Clinical Trials.
• Looking back and looking ahead: how controlling the outbreak affected running clinical trials and implications for implementation of vaccination programs.
Chapter 2 Features: Clinical Trial Supply
• Smart Packaging, Digital Labeling, and Drone Delivery Enabling Supply Chain of the Future
• Getting Vaccines to Patients from Manufacturing
• And more…
Chapter 3 Features: CRO Partnership and Development
• Development of modern biologics and cell therapy products through global CMOs
• Two sides of the same coin: Exploring the key considerations for a rapid study start up looking at the sponsor vs CRO point of view
• CRO, CRO – Wherefore Art Thou, CRO?