On-Demand Webinar
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.
What You’ll Learn
- How a unified eClinical platform replaces siloed point solutions so you can build a study once and enter data once.
- The ways Oracle Clinical One unifies people, processes, and data to accelerate the clinical trial lifecycle from startup to closeout.
- Practical insights and best practices for validating an Oracle Cloud environment.
- How USDM Cloud Assurance maintains continuous compliance using a Computer Software Assurance (CSA) methodology to modernize testing and documentation.
Watch the On-Demand Webinar
This session is available to watch on demand. See how rethinking the technology behind clinical trials — and pairing a unified platform with a continuous-compliance subscription — can save significant time across the study lifecycle.
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
- Q&A
The USDM point of view: Unifying clinical trial data on a single platform only delivers its full value when the environment stays validated as the platform evolves. Cloud applications update continuously, so one-time validation isn’t enough. USDM Cloud Assurance keeps Oracle Clinical One in an ongoing state of GxP compliance — applying a Computer Software Assurance (CSA) approach to protect data integrity and modernize testing and documentation — so study teams get the speed of one platform without taking on compliance risk.
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.
Frequently Asked Questions
What is Oracle Clinical One?
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. Instead of relying on a collection of siloed point solutions, study teams can build a study once, enter data once, and do everything in one place.
How does USDM Cloud Assurance support Oracle Clinical One?
USDM Cloud Assurance is a subscription service that supports Oracle Health Sciences’ Clinical One platform, ensuring the cloud environment is validated correctly and remains in a state of continuous GxP compliance as the platform evolves.
What is the CSA methodology and why does it matter for clinical trials?
Computer Software Assurance (CSA) is a risk-based approach that modernizes how validation testing and documentation are performed. Applied to Oracle Clinical One, it lets teams maintain continuous compliance while reducing unnecessary documentation effort. Learn more about Computer Software Assurance.
Why is a unified platform better than siloed point solutions?
Siloed data, fragmented technologies, and inconsistent operational practices create redundancy and inefficiency across clinical trials. A unified platform unifies people, processes, and data, which accelerates the trial lifecycle and removes the rework of moving data between tools that weren’t built to work together.
Where can I watch the webinar?
The session is available on demand. Watch it above, and contact USDM to discuss validating and maintaining continuous compliance for your Oracle Clinical One environment.
Ready to keep your Oracle Clinical One environment validated and continuously compliant? Talk to USDM about Cloud Assurance for your clinical trial platform.