ClinReg Strategy

Tips for meeting the ClinicalTrials.gov requirements

Introduction Welcome back! As a reminder, part 1 gave us insight in how to define, refine and freeze our clinical study design in ways that align with your overarching product development process. This is essential because your clinical data provides the most...

As a medical device CRO, we have the unique opportunity to help numerous clients across different therapeutic areas design and execute the best clinical study strategies for their specific needs. The consistency across these projects is the relationships we build, the...

Biomedical product development is an expensive, resource intensive process that requires extensive planning to ensure the product achieves market authorization within a defined timeline. Your clinical data may provide the most influential support for that market...

Many researchers, clinicians, and business leaders want to contribute in a meaningful way to the scientific community, and publishing research findings in a reputable scientific journal is an effective way to do that. While the journey to publication might seem brutal...

“Wait a minute, what did you just say?” More than once we’ve paused a conversation with clients to ask that question because hints about potential study-impacting changes were hidden within routine conversations or off-handed remarks. The trickle-down effects of...

Swift IDE approval is possible when your submission convinces FDA that you know your investigational device well and you have robust bench and pre-clinical data to demonstrate the device is ready for further evaluation in humans. This calls for clear technical, not...

The randomized controlled trial (RCT) is the gold standard of clinical research, providing the highest level of scientific data for evidence-based medicine, and is often referred to as “Level I” in literature reviews and meta-analyses. RCTs are usually the most...

Most leadership teams would agree that it is better to meet the timeline of a well-thought-out clinical study schedule than repeatedly miss the mark on an over-zealous one, even if the timeline is longer. No matter what your advisors told you, do not commit to your...

You are developing a medical device that addresses a clinical need, but how do you get it into the hands of physicians to improve the lives of patients? In this article, we discuss the most common FDA pathways to market clearance...