Clinical Study Startup Solutions

Optimize Site Selection

With inconsistent site profile and performance information spread across various systems, finding and enrolling qualified sites is predominately a manual, complicated, and lengthy process.

Select Cloud Service provides a data-driven approach to weighing selection and performance variables to aid in the identification of sites and target populations ideally suited to studies. Open sites on time and meet enrollment targets.

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Select Cloud Service Benefits

• Validate site performance to meet enrollment targets
• Integrate all data sources to create a comprehensive site profile
• Integrate workflows to complete all site identification and selection activities
• Reuse site profile data to maximize accuracy of data
• Utilize workflows to manage CDA, protocol amendments, site identification surveys, and prestudy visits
• Enable data-driven business decisions and transparency for regulatory compliance and risk mitigation

Driving Site Activation

Accelerating site activation can jumpstart a clinical trial, but with the hours and weeks spent manually tracking tasks and documents without visibility into where the bottlenecks lie, how can you make that happen?

Activate Cloud Service enables sponsors, CROs, and sites to get studies started in the shortest time possible. Activate workflows drive study teams to complete and track specific documents and tasks required for any site, country, or study based on regulatory and SOP requirements.

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Activate Cloud Service Benefits

• Improve operational performance with 70+ smart, standardized country workflows for quick study activation
• Automatically trigger workflows and alert study team members when prerequisite work is complete
• Ensure appropriate activity access with role-based assignments and retain knowledge even through staff turnovers
• Guide compliance with organizational SOPs and country-specific regulations
• Streamline document management by sharing study documents from a centralized library
• Deliver transparency with real-time study progress reporting and risk mitigation
• Enhance planning with predictive capabilities that guide team members in milestone planning activities
• Utilize multi-plan comparison and visualization tools to scenario plan optimal study setup

Leverage Business Intelligence

Communication and transparency are required for efficient clinical trials, but how can you do this when you’re working with multiple external partners all using different systems with inconsistent reporting conventions?

Analyze Cloud Service provides intelligence, presenting timely status updates across your studies and insights to streamline operational processes. Through visually rich analytics and dashboards, we help transition your team from a process that is reactive to one that is more proactive.

• Read the solution brief (PDF)

Analyze Cloud Service Benefits

• Provide actionable status information across your study portfolio in real-time with reliable metrics
• Quantify the team’s or CRO’s performance and eliminate time wasted on nonproductive activities
• Provide insights on where to focus resources to support at-risk regions or sites
• Enable real-time assessment of concurrent studies with multiple partners by tracking cycle time metrics
• Encourage high transparency partnerships and improve operational efficiency

Delivering CRO Oversight

For sponsors, improving oversight of study startup means real-time visibility into the progress of studies outsourced to their CRO partners, and transitioning away from tactical projects toward strategic partnerships, with both stakeholders having a vested interest.

Oracle Analyze Insight for Activate Cloud Service intelligence improves transparency, communication, and collaboration with CROs by providing sponsors with timely status updates and operational insights into outsourced studies with their CRO partners, leading to enhanced performance and governance. Through visually rich analytics and dashboards, we help transition your team from a process that is reactive to one that is more proactive.

• Read the solution brief (PDF)

Analyze Insight for Activate Cloud Service Benefits

• Standardize performance metrics across all studies and CRO partners
• Enable real-time assessment of concurrent studies with multiple CROs by tracking cycle time metrics
• Improve governance of outsourced studies and quantify performance of CRO partners
• Encourage high transparency strategic partnerships and improve operational efficiency by eliminating time wasted on nonproductive activities
• Build institutional knowledge on study dimensions to aid in proactive planning of future studies