Welcome to our blog, your go-to resource for the latest insights and trends in the life sciences industry.
Our blog is designed to provide expert guidance, practical tips, and thought leadership on key areas like medical device development, digital health, and clinical trial optimization. We cover a wide range of topics, including decentralized clinical trials (DCTs), the integration of digital health technologies (DHTs) in DCTs, and the use of Platform as a Service (PaaS) in medical device software development, to help you navigate the complex intersection of innovation and regulation. Our goal is to keep you informed and equipped with the knowledge needed to overcome industry challenges, drive innovation, and succeed in the rapidly advancing life sciences sector. Explore our blog for in-depth insights and the latest developments, and feel free to reach out if you need further assistance.
Categories:
- BYOD
- Clinical Research
- Cybersecurity & privacy
- Data Integrity
- Device Validation & Usability
- Digital Health
- Digital Health Technologies
- Digital health Technology
- Digital Transformation
- General
- Innovation
- Logistics
- MDR
- Medical Device Software Development
- Quality Management
- Regulatory
- Risk-Based Quality Management
- Usability
- Usability Testing
- Validation
- Wearables
“It’s Just a Phone”
Did you know a consumer smartphone can trigger four separate regulatory frameworks the moment it touches a clinical endpoint?
"Why do so many sponsors fail inspection on something they didn't think was a device?"
"Is your Regulatory Impact Assessment already out of date?"
"What does an inspector actually ask when they see a smartphone in your protocol?"
Sponsor Oversight of Digital Health Technologies in Decentralized Clinical Trials: A Regulatory Guide.
How do sponsors avoid becoming “accidental manufacturers” when deploying wearables in trials?
What happens if a consumer-grade DHT fails to meet regulatory validation standards mid-trial?
Why does FDA treat DHT oversight in drug trials with the same rigor as device investigations?
How can poor sponsor oversight of DHTs derail regulatory submissions and cause trial failure?
What practical frameworks exist to help sponsors manage DHT responsibilities across borders?