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.
reductions in cycle times
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.
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.
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.
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.
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.
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 (PDF)
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)
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 (PDF)
Automate activities and document workflows with country-specific smart workflows that deliver global regulatory and SOP compliance.Deliver organizational compliance (PDF)
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
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 effortsLeverage 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.”
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