Proxima CRO

We're honored to work with some of the leading innovators in the world, especially those leading the way for a healthier future for the next-generation. ? Meet our client: Dr. Chester Koh with SW Pediatric Device Consortium. Dr. Koh has built a world-class consortium helping innovators bring pediatric medical devices to market. "Developing medical technology for children has unique challenges. The Southwest National Pediatric Device Innovation Consortium (SWPDC) is a consortium supported by an FDA grant to assist innovators with their pediatric device development as well as address their regulatory challenges. Proxima has been a strong partner for us in helping guide innovators quickly through their regulatory and clinical journey." Working on the next generation of pediatric devices? We'd love to be a part of your journey. Reach out to our medical device experts at ProximaCRO.com #MedicalDevice #Pediatrics #FDA

Did you catch the session we led this morning at LSI USA? If not, schedule a meeting with Izzy Groot or Robert Cathell, MBA to get insight on how we're taking a smarter approach to development strategies! #LSIUSA25 #RegulatoryAffairs #ClinicalResearch #MedTech #QMS

Have you heard? Proxima's Izzy Groot and Robert Cathell, MBA will be attending the LSI USA conference in Dana Point next week! We're very excited to connect with old colleagues and new faces to continue to push the boundaries of innovation! Curious about how we can support your project? Send us a meeting request through the LSI partnering app, message us on LinkedIn, or email [email protected]! #LSIUSA #LSI2025 #MedTech #Innovation #MedicalDevices #Partnering #RegulatoryAffairs #ClinicalResearch

Exciting News! ?? Proxima's Jerika A. and Robert Cathell, MBA will be attending HIMSS in Las Vegas next week, and we’d love to connect! If you're attending, let's chat about Healthtech innovation and how we’re driving success in the industry. Let's network, discuss industry trends, and explore opportunities for collaboration. Drop a comment or send us a message if you’ll be there—we’d love to meet up! See you in Vegas! ? #HIMSS2025 #HealthcareInnovation #ClinicalResearch #Networking #Healthtech

?? **Kicking off 2025 with a Bang!** ?? ? As we reflect on the exciting changes and growth at Proxima over the past year, we are filled with gratitude for all the milestones we've achieved together. 2024 was a year of transformation, innovation, and continuous improvement, and we’re beyond thrilled to step into 2025 with even more energy and enthusiasm! ? Today, we are excited to welcome three incredible new team members to the Proxima family: ? ? Cherie Kaefring, our new Associate Director of Site Management and Monitoring, who brings a wealth of experience and a positive, solutions-driven mindset.?? ? Rob Cathell, our new Business Development Strategist, with fresh ideas and a determination to make an impact right from the start. ? Richard Jean-Simon, our new Clinical Trial Associate, whose passion will help drive our success forward.?? ? Their unique talents, experiences, and enthusiasm are already making a powerful difference, and we couldn’t be more thrilled to have them onboard as we continue to grow and innovate. ? Here’s to a 2025 filled with new opportunities and amazing collaborations!?? ? We’re so excited for what’s ahead and looking forward to accomplishing even more, together as a team. Let’s make this year our best one yet! #Proxima #WelcomeToTheTeam #2025Goals #TeamGrowth #Innovation #Success #NewBeginnings #LetsGo ??

We are searching for a Clinical Business Development professional to join our team! Please message us to find out more at [email protected].

Proxima CRO is proud to be a partner for MedTech Innovator (MTI), the world's largest accelerator of medical technology companies! This year marked the 12th year of MTI and the 10th year it was hosted at The MedTech Conference. Congrats to the winning innovators: ?? Grand Prize Winner: Samay, the first Latin American company accepted to MedTech ?? Execution Award Winner by MTI & AdvaMed Accel: SanaHeal, Inc. ??? Best Video Award: Ozlo Sleep MTI continues to advance the healthcare industry by accelerating the growth of companies transforming patient care. #healthcare #medtech #startup

Welcome to the team Kyle Thompson!

In today’s competitive landscape, we all know that launching a successful startup isn’t just about having a brilliant idea; it’s about teamwork and collaboration with a variety of stakeholders. ?#MTWMalta24 ?? We’re excited to invite you to a dynamic panel discussion on Day 2, November 7th, where we’ll explore the partnerships and strategies that truly contribute to building a successful startup ecosystem. We’re excited to welcome: ?Andrew Ortega-Verdaguer, CEO at IntelVasc Inc ?Thom Busby, Director at Outcome Capital ?Joseph Snyder, Principal at Lifeblood ?Chelsea Isaac, Director of Business Development & Marketing at Proxima CRO ?Braulio Ortiz, Principal and Co-Founder at BioTeknica Engineering & Regulatory Services ?Spencer Todd, CEO and Co-Founder at FormlyAI ?? Want to be part of #MedTechMalta2024 from November 6-8 in Valletta, Malta? Grab your spot here! ??? Spaces are filling up fast—secure your place today and use code Easy150EURoffMTWMalta to save €150! Register now. https://lnkd.in/d-iAfGDb ?Supported by: Lifeblood, Malta Enterprise, VisitMalta Incentives & Meetings, Malta Digital Innovation Authority, Ministry for Health and Active Ageing, Government of Malta. #MedTechWorld #Entrepreneurship #HealthcareInnovation #StartupFunding #InvestInMedTech

?? What is STeP (FDA's Safer Technologies Program)? Launched in 2018, the STeP program picks up where the breakthrough devices program left off. While breakthrough devices are required to treat life-threatening or irreversibly debilitating conditions, STeP devices are not. STeP devices are innovative devices that seek to remove some of the device complications or adverse side effects of the currently available devices or treatments for the indication. The FDA's STeP program: ? Targets non-life-threatening conditions (unlike Breakthrough Devices) ? Focuses on reducing complications and adverse effects ? Promotes innovative technological solutions ? Offers priority review and enhanced FDA interaction STeP Devices must meet the following criteria: ? Improved benefit-risk profile ? Innovative technology implementation ? Enhanced safety features or reduced risks STeP allows devices to have sprint discussions, accelerated review timelines, and direct engagement with FDA senior management. If you are curious if your device meets STeP or are looking for guidance, chat with one of our regulatory experts! ProximaCRO.com #MedicalDevice #FDA #MedTech