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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.

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. Outdated methods, such as Excel, lack project and risk management functionality.

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.

Study startup solutions

Industry-proven with global usage

30+%

reductions in cycle times

350,000+

sites activated

1,200+

sponsors/CROs

3,300+

studies

30+

therapeutic areas

50,000+

users

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.

Improve operational performance

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

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.

Ensure risk identification and mitigation

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

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

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

“Oracle offers enhanced visibility into the traditionally cumbersome process of activating sites for clinical trials. The system creates efficiencies through streamlined communication among sites, sponsors, and CROs. This ultimately drives shorter timelines and cost savings for our customers.”

Alistair MacDonald

CEO, Syneos Health

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