Regulatory Compliant Digital Health Technology Solutions (DHTS) and Services
Simplifying Development, Deployment and Scaling of Regulated Digital Health Products and Services
ClinSense™ provides you with a best-in-class AI-Based, scalable medical-grade platform and services to simplify the deployment and scaling of digital health offerings.
Our suite of solutions simplify clinical data collection, analysis, and output as well as drive a wide range of actionable insights. This allows for seamless incorporation of your data assets into medically and commercially relevant health solutions.
And when combined with our extensive regulatory knowledge and experience, we help you develop and implement comprehensive clinical programs that deliver high-value, compliant digital solutions, including Prescription Drug Use-Related Software (PDURS), Adjunct Digital Therapeutics (DTx), Companion Apps, and Drug-Device combinations (Rx+DTx).
ClinSense™ proven regulatory expertise and suite of end-to-end solutions:
- ClinSenseQMS™ Compliant, medical-grade quality management system (QMS).
- ClinSenseDB™ Compliant, regulatory-cleared, cloud-based database.
- ClinSense Endpoint Library™ Validated and/or experimental digital endpoints for integration.
- ClinSense Simulate™ Proprietary AI/ML aiHumanoid/Virtual Human Twin Platform.
Data. Done Right.
5 GOOD REASONS TO CHOOSE
ClinSense™ End-to-End Digital Solutions and Services
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Maximize Value and Efficiency
ClinSense™ simplifies development and use of asset de-risking and cash-recovery strategies at key strategic points throughout the development, market access, and lifecycle management phases. We improve data collection paradigms, eliminate risks with subjective endpoint measurements, and enhance operational efficiency. -
ClinSenseDB™: Your Data Storage and Sharing Solution
Our secure and compliant cloud-based platform enables seamless data collection, processing, analysis, and reporting. It supports integration with health sensors and electronic patient records, providing flexibility and security anytime, anywhere. -
Advanced Analytics and Out-of-the-Box-AI Integration Ready
ClinSenseDB™ features a robust Endpoint Library™ for top-tier analytics, including digital endpoints and biomarkers. Designed to harness the power of emerging AI technologies, like AI agents and Large Language Models (LLMs), our platform can deliver unparalleled insights. -
User-Friendly Interface
Our configurable User Interaction Layer and mobile app work to expand and enhance your data collection opportunities. The Interaction layer is designed to both simplify and personalise data collection and exchange, anywhere, anytime and throughout the various integrated ClinSense™ solutions. -
Compliance and Security
Our solutions are designed and developed using a regulatory-cleared Quality Management System (QMS). They follow industry best practices to ensure data security and privacy and are fully compliant with HIPAA and GDPR standards.
Regulatory Excellence Meets Digital Health Technology Innovation
ClinSense™ offers you a unique blend of best-in-class digital technology expertise with over 30 years of global regulatory and commercial experience in the life sciences industry. Additionally, we provide innovative and proven digital solutions to help clients enhance their therapeutic or medtech assets, whether through completely new developments or by adding value to existing ones. Supported by a team of over 250 experts in over 90 countries around the globe, we’re committed to helping clients achieve success in the rapidly evolving digital healthcare industry.
To learn more on how ClinSense™ can help you build your development programs or to schedule a consultation, contact us today.
Are you interested in implementing a digital health technology solution but finding it challenging to navigate the complex and constantly evolving global legal and regulatory requirements?
Reach out to us today to discuss how we can provide you with expert guidance.
We'll be more than happy to answer any questions you might have.
Give us a shout and we'll help you out.
Your Partner for Digital Health Applications
Whether your needs lie in Life Sciences, Healthcare, or both, regenold, through its ClinSense™ division, uniquely understands the scope of available digital health technology solutions and how to navigate the complex and evolving global legal and regulatory landscape. ClinSense™ can help your teams efficiently utilize these digital health technology solutions, design and deliver new, high-value compliant standalone digital health solutions, or both.
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