FSP Solutions
Preparing for EMA Policy 0070: How to Stay Ahead of the Anonymization Curve
Under Policy 0070 from the European Medicines Agency (EMA), sponsors are required to submit anonymized clinical reports for publication on the Clinical Data Publication (CDP) portal. Once published,...
Navigating the Regulatory Maze: Clinical Data for Medical Device Approval
In the world of medical devices, particularly those categorized as moderate to high-risk, clinical data is a critical component of the regulatory approval process. This data, presented to regulatory...
The Role of Clinical Data and Clinical Data Science
Clinical data and its analysis are critical to clinical research. Ensuring the overall quality of clinical data is then paramount to ensuring quality care and appropriate decision-making in the...
5 Ways the Medical Industry is Using Data Science
In the era of technological disruption, data science is a disruptor for the books. Today’s data scientists develop processes, algorithms, and systems to mine structured and unstructured data with the...