Why FDA’s Draft 510(k) Guidance is Forcing Sponsors to Rethink Device Submissions
The device team thought they were following the playbook. They chose a predicate that had been cleared two decades...
How Sponsors Can Win or Lose in the 510(k) Strategy Pathway
The start-up team was confident. Their Class II device had promising bench data, strong engineering, and investors eager for...
First UK GDPR Fine on Processor: ICO Targets Vendors
The UK Information Commissioner’s Office (ICO) has recently fined Advanced Computer Software Group Ltd £3.07 million for breaching the...
Understanding DPIAs in Clinical Research
Under the EU General Data Protection Regulation (GDPR), a Data Protection Impact Assessment (DPIA) is required when data processing...
Argentina Fines Ferring: Privacy Wake-Up Call for Pharma
In a precedent-setting decision, Argentina’s Data Protection Authority (Agencia de Acceso a la Información Pública – AAIP) has fined...
Privacy by Design in Global Clinical Trials
Multinational clinical trials are crucial for advancing medical innovation and improving patient outcomes. By including diverse populations, they provide...
Understanding the FDA’s Draft Guidance on Protocol Deviations in Clinical Investigations
The U.S. Food and Drug Administration (FDA) has released a draft guidance document titled Protocol Deviations for Clinical Investigations of...
Synthetic Data: A Real Fix for Clinical Trials?
The industry loves to celebrate synthetic data as a privacy solution—but where’s the real impact? Let’s be clear: privacy...
GDPR and Cross-Border Data Transfers in Clinical Trials
Cross-border data transfers are a critical yet complex aspect in clinical trials. With global collaborations becoming the norm, personal...
Ensuring Data Security Throughout the Trial Lifecycle
Clinical trials rely on robust data security measures to protect sensitive participant information, including personally identifiable information (PII) and...