Whether the product is a medical diagnostic tool, biologic, or medicine, regulatory restrictions must be carefully considered. Each milestone must be designed in conjunction with the company’s overall strategy, development timeframe, and regulatory approach. Every difficulty, too, must be approached intelligently. It might make or break the entire development process. Proxima assists in creating an effective plan, timeframe, and path. Proxima’s attention to detail and swift process enable them to collaborate with businesses to complete tasks quickly and efficiently. Proxima can provide rapid, thorough, and decisive consulting services, whether firms require help executing a full regulatory plan, making filings, or arranging a meeting with the agency. Excellent service is based on a thorough grasp of the customer’s expectations and the implementation of an efficient strategy. Their clinical research associates (CRAs) are top-tier professionals with therapeutic experience in biotech and clinical research’s most active fields. When an organization’s people, locations, and procedures are correctly aligned around the customer, outstanding service is feasible across all customer touch points. Employees on the front lines of Proxima are given the freedom to perform.

Life sciences firms of all sizes and phases, including innovators, nascent enterprises, and Fortune 500 corporations, turn to Proxima CRO for regulatory, quality, and clinical research expertise. Proxima CRO, based at the Texas Medical Institution (“TMC”), the world’s biggest medical center, serves hundreds of medical device, pharmaceutical, biotechnology, and diagnostic industries across 17 countries and five continents. “We are excited about our rapid and continued growth,” says Kevin Coker, co-founder and CEO of Proxima CRO. “We designed Proxima to be the premier clinical and regulatory resource to support the new class of rising stars in drugs, devices, diagnostics, and digital healthcare products. Emerging companies need flexibility, resources, guidance, and the ability to make decisions at speed, to a greater degree than established organizations. We pride ourselves on delivering the highest level of support and we are being rewarded for it in growth.”

Proxima can assist with access to investors, pairing with the right investors at the right time. From the business milestone assessments and minimum product profile to due diligence and deal flow, Proxima has got it fully covered. Our team of experienced clinical and regulatory professionals match your passion for disrupting the healthcare industry. Proxima utilize a project management style that incorporates agile project methodology, originally developed for the software industry, resulting in a process that is efficient and painless. Its Agile Project Management allows for responding to issues quickly. As the project progresses, velocity increases. An agile framework allows changes to be made quickly, which saves resources and accelerates delivery at a lower cost.

The company is formed with a team of experts with the right level of experience in clinical research management, operations, and regulatory affairs necessary to successfully execute medical device or drug clinical trial. In addition, the firm provides regulatory and clinical assistance, such as biostatistics, medical writing, data administration, and clinical monitoring, to help developing medical device and biotech companies complete their clinical trials effectively.

Proxima’s speed, agility, and unrivaled knowledge of the MedTech ecosystem can enable the medical device invention to advance quickly through regulatory, planning, and clinical trials, putting it in the hands of the people who need it most—patients. “Our growth is a direct reflection of the quality of our team and the people that work here,” says Coker. “The recognition and accolades we are receiving from reputable organizations like Inc. and Houston Business Journal, among many others, is further proof that we are on the right track and serving clients in the right ways.”

Proxima CRO recently reported that it had successfully authored and filed a 510(k) for the EvoEndo Model LE Single-Use Gastroscope, which is suitable for both pediatric and adult patients aged five and above. The Southwest National Pediatric Device Innovation Consortium (SWPDC.org), of which EvoEndo is a portfolio business and Proxima CRO is a service partner, provided grant funds for the proposal.

Proxima CRO was created to support new and aspiring inventors, as well as rising healthcare firms, with clinical, regulatory, quality, and go-to-market strategies in order to quickly get products authorized and to market. Regulatory, quality, and clinical trial skills, as well as finance and advice, are all available at Proxima to help bring products to market and launch new businesses to success. Their objective is to be a client’s ally, assisting them with regulatory, clinical, and reimbursement issues.