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.
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 Outdated methods, such as Excel, lack project and risk management functionality.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.
30+%
reductions in cycle times
350,000+
sites activated
1,200+
sponsors/CROs
3,300+
studies
30+
therapeutic areas
50,000+
users
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 performanceOversight 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 oversightReduce 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 mitigationDiscover 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 intelligenceAutomate activities and document workflows with country-specific smart workflows that deliver global regulatory and SOP compliance.
Deliver organizational complianceWith 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.”
CEO, Syneos Health
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