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Revolutionizing Clinical Trials with Cloud Concinnity 3.2.0

Published: 6/7/2024
      
clinical trials
Cloud Concinnity
FDA compliance
eClinical trial management
workflow automation
CRO
21 CFR Part 11
customization
efficiency
regulatory compliance

Key Takeaways

  • Cloud Concinnity's new release offers enhanced customization for clinical trial management.
  • The platform is 21 CFR Part 11 compliant, ensuring regulatory adherence.
  • Centralized and automated processes enhance efficiency and reduce costs in clinical trials.

Did You Know?

Did you know that Cloud Concinnity significantly reduces the cost of clinical trials while improving outcomes?

Enhanced Customization and Control

The Concinnity Company has recently launched Cloud Concinnity 3.2.0, an advanced platform for managing clinical trials. Designed to address the unique needs of each study, this update allows administrators greater customization. They can now specify tasks as 'notification only', meaning oversight members can receive documents without needing to act. This optimizes workflow and ensures that the right individuals receive necessary updates while unnecessary steps are skipped— all tracked with a detailed audit trail.

With these customization options, administrators can more effectively manage document distribution, surveys, and forms. This flexibility enhances efficiency and accuracy, ultimately making it easier to respond rapidly to sponsors and regulatory bodies.

Meeting Compliance Standards

Cloud Concinnity is built to comply with 21 CFR Part 11, a set of regulations established by the FDA for electronic records and signatures. This compliance is validated through external audits by leading experts in the field. The new release includes multiple 21 CFR Part 11 compliant signature integrations directly within workflow features. By embedding eSignatures, the platform ensures consistent documentation and compliance, making it easier for administrators to meet regulatory requirements.

Streamlined and Modern Clinical Trial Oversight

Clinical trials often suffer from inefficient processes and outdated technology. Cloud Concinnity addresses these issues head-on by offering a centralized system that enables collaboration and ensures compliance. It eliminates the need for multiple tools, thereby increasing efficiency and reducing the cost of clinical trials.

The centralized approach of Cloud Concinnity offers significant advantages, including streamlined processes, better collaboration, and optimized compliance—all of which are crucial for achieving better outcomes in clinical trials.

Driving Efficiency and Growth

Cloud Concinnity stands out with its powerful, integrated workflow engine. This engine is designed to standardize and optimize processes, enhancing both capacity and controls. These improvements lead to increased efficiency and foster growth by ensuring preventive compliance. Ultimately, the platform promises better outcomes at lower costs.

This system brings together centralization, collaboration, and compliance to critical clinical trial processes. The result is a more efficient, effective, and scalable approach to managing clinical trials.

Transforming Clinical Trial Management

Cloud Concinnity transforms how clinical trials are managed. By standardizing and automating essential activities, it allows for faster execution and better decision-making. The platform unlocks the value of big data buried in multiple systems, making it easier to manage product lifecycles and improve decision-making processes.

This innovative tool harnesses the power of process management, innovation, and technology to create a stronger, healthier world. It aims to bring treatments to patients more swiftly and cost-effectively, benefiting both the healthcare industry and patients alike.

Conclusion

Cloud Concinnity 3.2.0 represents a significant leap forward in clinical trial management. By offering enhanced customization, compliance with industry standards, and a focus on efficiency and collaboration, this platform sets a new standard for clinical trial oversight. For more information or to get in touch with The Concinnity Company, visit their website or contact them directly.

References

  1. FDA - Title 21 CFR Part 11
    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/title-21-cfr-part-11-electronic-records-electronic-signatures-scope-and-application
  2. eClinical Trial Management Systems
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3150284/
  3. Role of Technology in Clinical Trials
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6800454/