Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies
On January 7, 2025, the FDA issued a draft guidance document on “Evaluation of Sex-Specific and Gender-Specific Data in Medical Device Clinical Studies”. This draft guidance emphasizes the importance of inclusive and representative research to ensure devices are safe and effective for diverse populations. This guidance builds on the previous “Evaluation of Sex-Specific Data in […]
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 […]
European Commission’s Guidance for Joint Clinical Assessments
In an effort to streamline and enhance the evaluation of health technologies across Europe, the European Commission has released a comprehensive guide focused on the validity of studies for joint clinical assessments (JCAs). This initiative, rolled out under the EU Health Technology Assessment Regulation (HTAR), represents a significant step toward harmonizing the assessment of new […]
Developing Diversity Action Plans within Underrepresented Populations
The FDA’s draft guidance, titled “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies,” outlines the agency’s expectations for sponsors of clinical studies involving drugs, biological products, and devices. The primary goal of this guidance is to enhance the inclusion of underrepresented populations in clinical research, ensuring that study findings […]
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 […]
Navigating the EU Clinical Trials Regulation (CTR)
The European Union Clinical Trials Regulation (EU CTR) represents a landmark shift in the regulation of clinical research within the EU. Enacted to streamline and harmonize the conduct of clinical trials across member states, the CTR aims to enhance patient safety, promote transparency, and facilitate the timely initiation and completion of clinical research. As the […]
The EU IVDR Impact on Clinical Trials
The European Union In Vitro Diagnostic Regulation (EU IVDR) stands as a pivotal framework shaping the landscape of medical device regulation within the EU. While primarily targeting in vitro diagnostic (IVD) devices, its ramifications extend beyond mere device certification. Among its ripple effects lies a significant impact on clinical trials, particularly those involving IVDs. Understanding […]
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 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 […]
