Vigilant Clinical Trials Consulting has a superior  understanding of the medical device life cycle. And creating a plan for every medical device which is comprehensive and unique to the device needs. We build clinical plans for your device that includes the full development path based on needs that can encompass proof of concept, FDA clearance and post market testing. We work with you  to develop the ideal path forward that paves the way to get your device to market faster.

Once you engage our services, together, we will create and execute a plan for your clinical studies. Our work can include everything from planning, to authoring documents, FDA documentation authoring, engaging and managing IRB submissions, study site engagement/ assessment, site training and study management. We will engage experts from your team and ours. These experts will include regulatory, statisticians, engineering/manufacturing, medical , and marketing to make sure we have a full picture to optimize for your specific device needs.