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Clinical Study Startup Solutions

Sponsors and CROs face intense pressure to speed clinical trials and restrain costs, but current industry processes are woefully inadequate at helping stakeholders spot risk factors and bottlenecks that can disrupt cycle times and budgets. Oracle’s suite of study startup solutions (PDF) for starting clinical trials—through site identification, feasibility, selection, activation, and into conduct—can help get needed therapies to patients sooner.

Industry-proven with global usage

More than

30%

reductions in cycle times

More than

465,000

sites activated

More than

1,500

sponsors/CROs

More than

4,600

studies

More than

30

therapeutic areas

More than

50,000

users

Study startup is key to operational success

At the outset of clinical trials, study startup is hindered by inefficient ways of capturing and analyzing operational data. Purpose-built tools for study startup automate workflows that guide team members through the many steps involved and provide alerts for tasks needing attention. Real-time status checks, performance metrics, and advanced planning capabilities are critical to building a dynamic atmosphere of continuous improvement.

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.

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.

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.

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.

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
 

Start clinical trials faster with Oracle's study startup solutions

Improve operational performance with 70 smart, standardized country workflows for quick study activation

Automate the manual, cumbersome, and error-prone processes and tools that are not specifically built for study startup. Automatically trigger workflows and alert study team members when prerequisite work is complete.

Enable real-time assessment of concurrent studies with multiple CROs by tracking cycle time metrics

Oversight is simplified with a single on-demand view, delivering instant status updates on study progress, irrespective of how many concurrent studies or vendors you work with. Transition your team away from a process that is reactive to one that is more proactive.

Drive oversight (PDF)

Deliver transparency with real-time study progress reporting and risk mitigation

Reduce your clinical trial risk by deploying purpose-built study startup technologies that aid in risk management. Immediately identify at-risk areas for mitigation or prevention steps.

Guide compliance with organizational SOPs and country-specific regulations

Automate activities and document workflows with country-specific smart workflows that deliver global regulatory and SOP compliance.

Deliver organizational compliance (PDF)

Proactive planning is key to process and quality improvements in clinical trials

With the availability of workflow-based, study-startup tools, proactive planning, process optimization, and quality improvements—as measured by inspection-readiness and the likelihood of passing regulatory audits—are all within reach.

Enhance quality outcomes

Find out where to focus your efforts, and eliminate time wasted on nonproductive activities

Discover bottlenecks and areas for process improvements with custom analytics and real-time metrics into ongoing operations. Provide actionable, quantifiable performance metrics to drive process optimization efforts

Leverage business intelligence

“Oracle empowers our visibility into the traditionally cumbersome process of activating investigative sites for clinical trials. Additionally, capturing robust clinical and operational data allows us to enhance our predictability model for forecasting.”

Carol Aliyar Executive Vice President, Syneos Health

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