CER and Literature Search Remediation
Challenge: Approach: AlvaMed implemented the following approach: Results: AlvaMed delivered the following: Impact: Project is a heavy time burden and lift for a company, especially if they are limited with resources to dedicate to this type of remediation effort. Also, it allows a group of experts to step in, who deal with these types of […]
Clinical Strategy & Protocol Development
Challenge: A small company specializing in an innovative robotic platform technology for precision surgery in oncology approached AlvaMed for CRO support. The client’s goals were to develop a clinical strategy and a study protocol with support documents (consent, Case Report Forms (CRFs), regulatory documentation) aligned with that strategy. Additionally, they wanted to have a study-ready […]
Accelerating Clinical Trials in the EU: Two Pilots Go Live
Clinical trials are the cornerstone of medical innovation, driving the development of new treatments and therapies that improve patient outcomes and advance healthcare. However, the traditional clinical trial process is often lengthy and complex, posing significant challenges for researchers, sponsors, and patients alike. The COVID-19 era brought a decrease in multi-state clinical trials applications in […]
Clinical Evaluation – Single-Use Overtube
This case study exemplifies AlvaMed’s ability to guide clients through intricate regulatory landscapes, ensuring compliance and accelerating market entry.
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 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 […]
