Navigating clinical trials with confidence: Oracle's integrated approach

Achieving success in the evolving life sciences industry requires effective clinical trial planning and financial management. A recent webinar on the integration of Oracle ClearTrial with Oracle Cloud EPM brought together industry leaders to discuss how this powerful combination can transform the way life sciences organizations operate. The session featured a deep discussion from Brad Fisher, Prasad Joshi and Mario Prohasky from Baker Tilly and Kristin Ludwig from Oracle, who shared their insights and enthusiasm for these two fabulous Oracle SaaS innovative products. 

Understanding ClearTrial 

Kristin Ludwig, Senior Principal Engineer at Oracle’s Life Sciences business unit and a 17-year veteran of ClearTrial, began by explaining the core functionalities of Oracle Life Sciences ClearTrial. ClearTrial is designed specifically for planning and outsourcing clinical trials, tailored for life science customers. The primary customer base consists of sponsors responsible for overseeing and managing their clinical development pipeline. For sponsors, ClearTrial enhances clinical trial planning and sourcing, improving speed, efficiency and accuracy. 

Contract research organizations (CROs) focus on preparing proposals to submit to their sponsor clients. They benefit from ClearTrial's framework, which offers pre-built clinical intelligence to understand the complexities of a trial based on phase Therapeutic area and indication. This allows CROs to benchmark themselves before submitting proposals back to their sponsor clients. For CROs, ClearTrial streamlines the RFP development process, reducing cycle times and leveraging validated benchmarks.  

This tool is designed to improve the overall efficiency of clinical trial planning and delivery, ensuring that life sciences organizations can make informed decisions quickly. 

ClearTrial also plays a crucial role in mitigating risk, helping life sciences organizations navigate the complexities of clinical trials, through scenario planning and trial design optimization with greater confidence and precision. 

Integration with Oracle Cloud EPM 

Prasad Joshi, Senior Manager at Baker Tilly with over 20 years of implementing EPM solutions and extensive experience in healthcare and life sciences, emphasized the significance of integrating ClearTrial with Oracle Cloud EPM. This bundled solution offers unmatched visibility and control over research and development (R&D) spending, enabling life sciences companies to plan and assess the financial impact of clinical trials with greater granularity. The integration facilitates real-time synchronization, accurate forecasting and proactive strategic planning, allowing organizations to optimize their R&D spending and improve financial planning.  

Enhanced reporting and analytics 

Brad Fisher, Senior Director of Baker Tilly’s Oracle Solutions practice, highlighted the importance of budgets versus actuals reporting. Oracle EPM's robust reporting and analytic capabilities allow organizations to roll up data into management reports and presentations effortlessly. This feature is a huge time saver, enabling leaders to make informed decisions quickly and efficiently. The ability to leverage actuals in EPM pulled from ERP systems automates management reporting, improving operational efficiency. 

Understanding whether trials are running on time and on budget is crucial as its typically the largest expense item for these organizations and delays can typically cost organizations huge amounts of money which can be the difference between solvency and bankruptcy in pre-revenue biotechs. ClearTrial and EPM provide insights into study progress, helping organizations mitigate risks and make data-driven decisions. This visibility is essential for managing the complexities of clinical trials and ensuring that they align with initial plans. 

Risk management and compliance 

Mario Prohasky, Director at Baker Tilly with over a decade of experience with a strong subject matter focus on life sciences, discussed the impact of the new offering on risk management and compliance. The integration improves the accuracy and efficiency of clinical trial planning, helping organizations manage R&D spend and engage with external stakeholders more effectively. This reduces the risk of non-compliance and enhances overall operational efficiency. The ability to automate processes and leverage artificial intelligence (AI) and machine learning further supports risk mitigation strategies. 

Streamlined financial close and reconciliation  

FCCS (Financial Consolidation and Close Service) and ARCS (Account Reconciliation Cloud Service) in EPM streamline financial close and reconciliation processes, which is particularly beneficial for small biotech companies with lean accounting teams. Automating these tasks reduces manual effort, improves accuracy and ensures compliance, enhancing visibility and accountability for better decision-making. 

By leveraging FCCS and ARCS, life sciences organizations can create a more efficient, transparent, and compliant financial close process, allowing finance teams to focus on strategic initiatives rather than manual reconciliations and tracking. 

Real-world ROI and savings 

Integrating ClearTrial and EPM helps organizations identify key cost drivers, run multiple scenarios and negotiate fair market value pricing with CROs. This leads to significant cost savings and improved decision-making. A key benefit of this integrated solution is the ability to take immediate action based on analytics data, improving enrollment, addressing delays and optimizing resources. 

Check out the webinar for more examples of potential ROI and savings 

How we can help 

The integration of ClearTrial with Oracle Cloud EPM promises to transform clinical trial planning and financial management, offering life sciences organizations a powerful tool to optimize R&D spending and improve overall performance. By leveraging the strengths of both ClearTrial and EPM, organizations can enhance their operational efficiency, mitigate risks and make more informed, data-driven decisions.