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:
- Clinical Research
- Cybersecurity & privacy
- Data Integrity
- Device Validation & Usability
- Digital Health
- Digital Health Technologies
- Digital health Technology
- Digital Transformation
- General
- Innovation
- Logistics
- Medical Device Software Development
- Quality Management
- Regulatory
- Risk-Based Quality Management
- Usability
- Usability Testing
- Validation
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?
Quality-by-Design for DCTs: Turning FDA’s DHT Framework Into an Inspection-Ready Reality
Could your digital endpoints survive if an FDA inspector asked you to “show how this was generated”?
Are your device, algorithm, and data teams aligned—or are they assuming someone else is handling the risk?
Do your SOPs actually support decentralized trials, or are they relics from the site-centric era?
Would your DHT data hold up across review divisions, or would firmware drift and missing lineage collapse your evidence?
Is your organization prepared for the roles it already holds—sponsor, architect, system producer, and regulated partner?
The 2024 FDA DCT Guidance Decoded: 9 Operational Traps Sponsors Still Fall Into
What hidden operational traps are still tripping sponsors under the 2024 FDA DCT guidance?
How can sponsors maintain investigator oversight across decentralized models?
Why does device validation remain a recurring inspection finding?
What data integrity gaps most concern regulators in decentralized trials?
How can operational alignment with FDA guidance accelerate study approvals?