Clinical trials have been plagued with redundancy and inefficiency due to siloed data, fragmented technologies, and inconsistent operational practices. Today’s study teams and sites rely on a collection of siloed point solutions that simply weren’t built to work together. What if you could build a study once, enter data once, and do everything in one place? Oracle Clinical One is a next generation unified eClinical platform that harmonizes data, streamlines workflow, and saves significant time from study startup to study closeout.
USDM Cloud Assurance™ subscription service supports Oracle Health Sciences’ Clinical One platform to ensure your cloud environment is validated correctly and remains in a state of continuous GxP compliance.
The discussion included:
- Rethinking ways technology can support the entire clinical trial lifecycle
- How Oracle Clinical One unifies people, processes, and data to accelerate clinical trials
- Benefits of managing clinical trials in one platform
- Oracle Cloud validation insights and best practices
- How USDM Cloud Assurance maintains continuous compliance and uses a CSA methodology to modernize testing and documentation with Oracle Clinical One
About the Presenters
Andy Alasso, Global Vice President of Product Management, Oracle Health Sciences
Andy and his team are responsible for defining, specifying, and facilitating the delivery of more than 20 products within Oracle’s Clinical Research, Pharmacovigilance, and Healthcare portfolios. Overall, Andy has over 25 years of experience in providing software solutions to the life sciences and healthcare industries.
Michael Ventresca, Senior Product Manager, Oracle Health Services
Michael oversees Product Verification Package (PVP) activities across HSGBU product groups. He has over 15 years of experience working in clinical trial settings with experience in the following areas: product and service level validation, requirements and medical writing, data management, and risk and regulatory compliance.
John Petrakis, Vice President Cloud Assurance, USDM Life Sciences
John has 30 years of global industry experience in business transformation, delivering solutions that address regulatory and quality pressures. John has led all aspects of strategy development and delivered value for pharmaceutical, biotech, medical device, and healthcare companies through application development and maintenance, ERP, advanced analytics (RPA/AI/ML), cloud compliance, and cybersecurity.