CE marking provides access to a market of over 500 million consumers across all 27 member states of the European Union (EU), as well as Iceland, Norway, and Liechtenstein. For medical devices and in vitro diagnostics (IVDs), a CE mark...
Premier Research
Medical Device
5 Stages of Medical Device Development
Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to...
Rare Disease
Why Rare Disease Day Matters to Us
An estimated 300 million people globally suffer from a rare disease. Further still, 25 million people in the U.S. alone are living with an undiagnosed rare disease. Limitations in disease understanding and lack of approved treatments can mean countless challenges...
“You have cancer.” It’s something you hope to never hear. For so many of us at Premier Research, we’ve watched loved ones fight for their lives — or fought for our own. That’s why we choose to work at Premier,...
In the past, medical device developers often chose to bring new products to market in the EU first since obtaining a CE mark was perceived to be faster, less expensive, and more predictable than securing US FDA clearance or approval....
An investigational device exemption (IDE) allows an investigational device to be used in a clinical study to collect safety and effectiveness data.[1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This...
“Artificial Intelligence (AI) and Machine Learning (ML) as a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks and exhibit behaviors such as learning, making decisions, and making predictions. ML is considered a subset...
In the field of oncology, as we got better at understanding the changes that occur in cancers at a molecular level, we have seen a shift towards precision medicine. Biomarkers are central to this change and can be leveraged to...
The FDA’s Center for Drug Evaluation and Research issued a structured, meticulous roadmap to advance the clinical development of psychedelic drugs, highlighting key considerations in regulatory frameworks, ethical conduct, chemistry manufacturing controls (CMC), and clinical studies to ensure safety and...
Oncology & Hematology
Operationalizing Biomarker-Guided Oncology Trials: Planning for Success
Advances in genomic and proteomic technologies have led to the identification of numerous biomarkers with potential clinical utility in oncology, including gene mutations, gene amplifications, gene expression signatures, and altered proteins. To date, more than 1,500 potential oncology biomarkers have...