Datatrial Nucleus Description
Discover a comprehensive platform designed for researching, documenting, and organizing your clinical data seamlessly. The Nucleus platform streamlines your research data management, providing a unified space for storing study documentation, clinical datasets, submission materials, and compliant media. With Nucleus Documents, you can efficiently manage documents and maintain version control for your quality documentation and media assets. Easily oversee, manage, and share your organizational content without hassle. Additionally, effortlessly compile and regulate your electronic trial master file documents through our centralized regulatory document management system. Nucleus Coding facilitates dictionary term coding for both MedDRA and WHODrug dictionaries, available as a standalone application or integrated within your data capture system, ensuring flexibility and efficiency in your coding processes. This comprehensive solution not only enhances data integrity but also optimizes collaboration across your research teams.
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Built for sectors that depend on strict oversight, such as aerospace, life sciences, public sector, and financial services, IMS offers real-time monitoring, automated workflows, and AI-driven analytics that strengthen quality and lower operational exposure. The system is ISO 27001 certified and validated for 21 CFR Part 11, ensuring secure and compliant use in regulated operations. IMS also provides low-code automation, process mining, audit tools, training management, CAPA workflows, and dashboards that help organizations improve performance and maintain regulatory control. AI enhances governance, improves precision, and supports continuous compliance.
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Nucleus RTOS
Nucleus® RTOS empowers system developers to meet the intricate demands of modern embedded designs. By combining a robust kernel with essential tooling features, Nucleus is perfectly suited for applications that prioritize scalability, connectivity, security, power efficiency, and reliable deterministic performance. This real-time operating system is not only proven and dependable but also fully optimized for various applications. It has demonstrated success in demanding sectors that require stringent safety and security standards, including industrial systems, medical devices, airborne systems, and automotive applications. Nucleus features a stable deterministic kernel designed to occupy minimal memory, complemented by a lightweight process model that enhances memory partitioning. Additionally, it supports dynamic loading and unloading of processes, allowing for increased modularity in applications, thus providing developers with the flexibility needed for diverse project requirements. This adaptability ensures that Nucleus RTOS can effectively cater to the evolving landscape of embedded technology.
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ClinSoft
ClinSoft™, was developed in-house by Innovate Research. There were no third-party acquisitions and integrations. The system is compliant to FDA regulations (21 CFR Part 11, as well as GCP and HIPAA. The system is fully auditable and validated. ClinSoft™, which is easy to use, ensures quick start-ups and close-outs. This saves you precious time and allows you to be certain that any mid-study amendments or updates to protocols will be made promptly. Innovate Research, an Indian contract research company, provides services in clinical research and regulatory affairs. US FDA 21 CFR Part 11 compliant. Electronic Signatures & Records Secure, Role-Based Access. Audit Trail. Easy to use interface for Edit Checks and CRF Set-up. Frameworks that can be reused for item, panel, visit, and page.
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Pricing
Free Version:
Yes
Integrations
No Integrations at this time
Company Details
Company:
Datatrial
Year Founded:
1999
Headquarters:
United Kingdom
Website:
www.datatrial.com/nucleus/
Media
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Product Details
Platforms
Web-Based
Types of Training
Training Docs
In Person
Customer Support
Online Support
Business Hours
Datatrial Nucleus Features and Options
Clinical Trial Management Software
21 CFR Part 11 Compliance
Document Management
Electronic Data Capture
Enrollment Management
HIPAA Compliant
Monitoring
Patient Database
Recruiting Management
Scheduling
Study Planning
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