The drive for efficiency and innovation is paramount in the technologically advanced and continuously evolving field of pharmaceutical and biotechnical research. Yet, many organizations find themselves bogged down by the costly and time-consuming task of validating open-source packages for clinical analytics. This is where we come in.  

OpenVal® by Atorus Research provides a transformative solution, with validated open-source packages tailored specifically for clinical programming. This is a game-changer designed to streamline this process and dramatically improve your ROI. 

The Challenge of Validating Open-Source Packages 

Validating open-source packages is no small feat, requiring a substantial commitment of resources. Traditionally, organizations have been forced to independently ensure that each package meets strict regulatory standards, a process that involves overcoming a series of hurdles: 

  • Package Selection: Relevant, quality packages for clinical programming need to be identified from thousands of open-source packages on GitHub, Bioconductor, and CRAN 
  • Extensive Validation Demands: Each package must be individually tested and validated to ensure that it produces the results that it is supposed to, a process that is both time-consuming and costly 
  • Frequent Updates and Maintenance: Open-source packages are regularly updated, necessitating ongoing validation to ensure compliance and functionality 
  • Documentation and Regulatory Compliance: Precise documentation for reproducibility and traceability is required for regulatory audits, significantly increasing the administrative burden 

Managing this labor-intensive process distracts organizations from what should ideally be their core focus: innovation and the deployment of critical research applications. 

Validated R Packages: A Closer Look at OpenVal®’s Core Components 

OpenVal® represents a comprehensive ecosystem custom-designed to cater to the requirements of clinical programming. By integrating rigorous validation processes and maintaining a consistent update cycle, we ensure our leading-edge offerings are reliable and always compliant with the latest industry standards. 

How OpenVal® Works to Overcome Your Validation Challenges 

  • Discovery and Planning: Packages are selected by Atorus subject matter experts in collaboration with OpenVal® customers and industry experts 
  • Risk Assessment: A risk is assigned to determine the level of testing needed. Criteria for risk include the type of package as well as metrics such as number of downloads, number and type of references, and vignettes 
  • Testing: Requirements, test cases, and test code are written by subject matter experts to verify the package produces an accurate and/or acceptable result; testing is run across multiple operating systems and uses Atorus’ automated framework which saves the human time of manual execution of tests 
  • Delivery and Installation: OpenVal® is installed in a customer’s environment and an installation guide is provided detailing every step of installation 
  • Regular Updates and Maintenance: Major release cycles are biannual, and the latest package version and R version are integrated 

This strategic composition of OpenVal® makes it an indispensable resource for clinical data analysts and engineers, enhancing productivity and ensuring compliance. 

How OpenVal® Optimizes ROI  

While OpenVal® indeed optimizes ROI by taking the initial in-house validation process off your plate, it does much more than that. It strategically enhances the efficiency of clinical research by focusing on several critical aspects that distinguish its value proposition. 

Continuous Management and Maintenance of Changes 

OpenVal® handles the complexities of change management. Open-source evolves quickly. The validation process ensures validation is accurate for both package versions and R versions as they change over time.  

Rapid Deployment Capability 

OpenVal® packages are not only validated but are also configured for immediate deployment, allowing research teams to bypass the lengthy setups that are typical when starting new projects. This immediate usability accelerates the pace of research and reduces creativity- and productivity-draining lag time, enabling quicker transitions from conceptual stages to actionable insights. 

Cost Reduction Through Centralization 

OpenVal® centralizes the validation process, reducing the redundancy of multiple teams performing parallel validations. This significantly reduces the overhead costs associated with individual validation efforts and frees up resources that can be redirected toward primary research goals — what you want to be doing! 

Enhanced Regulatory Compliance 

The rigor of OpenVal®’s validation process ensures that every package produces the expected result. This meticulous process minimizes the risks of regulatory infractions and enhances the reliability of research outcomes. 

Conclusion: Why OpenVal® Is Essential for Clinical Research 

OpenVal® by Atorus is a transformative solution for clinical data analytics, effectively addressing the challenges of validating open-source packages within a regulated environment. How? Because you don’t have to do it.  

By offering validated packages and maintaining them over time, OpenVal® ensures your organization can jump-start projects with confidence, knowing you’re equipped for compliance and optimized for performance. 

But the benefits of choosing OpenVal® extend beyond compliance and efficiency. We enable you to harness the full potential of your data, facilitating strategic decision-making backed by accurate, reliable analytics. The integration of OpenVal® into your operations means you won’t just be keeping up with industry standards; you’ll be setting new benchmarks for quality and innovation in clinical data management. 

We do the work so you don’t have to. 

Ready to transform your data science operations? Reach out to our team at Atorus to learn more about this revolutionary product and start your journey toward streamlined, compliant, and effective data analytics. 

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