The Outsourcing in Clinical Trials Handbook
The go-to guide for professionals in the global clinical outsourcing space
Building on the world-renowned Outsourcing in Clinical Trials series, Arena International is proud to announce the arrival of the second Outsourcing in Clinical Trials 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. Based on in-depth research with experts in the clinical trial space, this manual provides informative checklists on an international level to allow companies to optimize their clinical trial operations and promote regulatory compliance. This is particularly important with Covid-19 making it increasingly difficult to share industry updates face-to-face.
Comprising of industry written pieces and advice, the handbook will also include a comprehensive supplier directory, providing readers with a onestop shop for sourcing vendors for their outsourcing needs.
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Key Content Areas
The Outsourcing Clinical Trials Handbook will kick off by looking into the regulatory aspects of conducting trials in the US and Europe within the context of Brexit and the new Trump administration. It will also look into the challenges of entering emerging regions, as well as providing a market analysis of the latest M&A trends within the industry.
– Update to ICH GCP E6 guidelines and how it will be implemented the era of Brexit and the Trump administration
– Challenges of conducting trials in China
– Mergers & Acquisitions outlook
Clinical Trials in Oncology
– Immunotherapy combination trials
– Constructing site budgets that are fair
– Oversight management
Data Management in Clinical Trials
– Adverse Event Reporting
– Risk based monitoring and central monitoring challenges
– Data fraud
– Maintaining quality and regulatory compliance during M&As
– Medical device regulations
– FDA regulatory update
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