Decentralized Clinical Trials: A Clinical Trial Optimization Opportunity
Recent trends in clinical studies, including the nearly ubiquitous move to electronic data capture (EDC) systems across CROs/sponsors and electronic medical records (EMR) systems amongst hospital systems/private practices, has provided a fertile environment in which to institute decentralized clinical trials (DCTs). The additional factor of the COVID-19 global pandemic ushered in a need to explore […]
Class III FIH Trial
CLASS III FIH TRIAL CHALLENGE:A Class III medical device startup required clinical affairs and submission support for a First in Human (FIH) study to evaluate a novel neurology implant. The company made the strategic decision to do initial clinical evaluations outside the US to prove out the device design and use the data to support […]
IDE Study
IDE STUDY CHALLENGE:A medical device startup required expertise in designing, managing, and executing an investigational device exemption (IDE) study for their tissue-ablation device. The IDE clinical trial was conducted to add a new indication for the device (treating walled off pancreatic necrosis by performing direct endoscopic necrosectomy). The device had been previously approved in the […]
Clinical Study Management
CHALLENGE:A small medical device start-up required support planning, managing, and executing a post-market clinical study for their Endoluminal Occlusion System (EOS™) devices. The sponsor required an immediate plan to transition the ongoing study to AlvaMed and to open up a new treatment arm for the study. A project plan and tracking tools needed to be […]
