Cancer Prevention and Research Institute of Texas (CPRIT)

Clinical, Regulatory & Quality Support for CPRIT-Funded Innovation

CPRIT is one of the world's largest cancer research funders, investing directly in Texas companies building cancer devices, diagnostics, therapeutics, and new technologies.

Based in the heart of the Texas Medical Center, Proxima Clinical helps you turn a CPRIT product development award into clinical progress, from regulatory strategy to trial execution.

Get CPRIT-ready

One of the world's largest cancer research programs,
delivering milestone-based contracts

CPRIT funds Texas-based academic research grants and companies through dedicated product development awards. Because reviewers score an integrated clinical and regulatory plan, a fundable application depends on exactly the substance emerging innovators often lack in-house.

Founded at the Texas Medical Center, Proxima helps companies build that application, and execute after the award.

We are proud to have 7 CPRIT Awarded Clients.

Our Process Why Proxima Our Experience

"The projects are very interesting as they deal a lot with niche products, and products that are seeking for a market. The people are fantastic, funny, open minded, tolerant, adorable, intelligent, competent, but above all they are motivated."

Position

First & Last Name

Position

First & Last Name

“As a busy surgeon developing a Class III implantable device I needed help with regulatory strategy and execution. I wanted someone that was as passionate about the device as I was and that could hit the ground running. Because PROXIMA supports emerging companies through Med Tech Innovator they were a perfect fit. Isabella also helped us manage other vendor relationships and kept things moving forward. I been very happy working with PROXIMA”

Founder

Marc Bessler, M.D.

“Proxima has been such a wonderful help every step of the way. Everyone is truly great to work with.”

Junior Project Engineer

Karen Wells

"Proxima has been attentive to a variety of our regulatory related needs. From coordinating studies with aggressive timelines to assisting with sales aid approvals, they have always delivered. As we launched our first in class/disease product, we needed a high touch clinical research and regulatory partner, and Proxima has provided that for us."

Founder & CEO

Robert Whitehead

"The wonderful people at Proxima have been dogged champions for our success. Aside from being deeply experienced in our particular field and keenly knowledgeable on developing trends they take our success as personally as we do. That, as much as anything, has been the difference."

COO & Co-Founder

Geoffrey Lucks

We joined forces with Proxima's Quality Consultants to ready ourselves for upcoming audits of both our QMS and our parent company's QMS. Their approachable, expert team delivered essential support and insightful guidance, never shying away from directing us confidently towards the right path. We are proud to share our spotless ISO 13485 recertification audit, a testament to Proxima's steadfast commitment and fearless leadership!

Regulatory & QA Manager

Michael Selva

Proxima has been an important piece of Memgen's regulatory and clinical achievements for multiple years now, playing a vital role in our IND approval, clinical launch, and trial management of our first-in-human study of our lead cancer immunotherapy biologic. Proxima and its growing team have continually shown their experience, broad skill sets, adaptability to our company's needs and objectives, and value in an industry with a myriad of CROs to choose from.

CSO

Mark Cantwell

We have had the pleasure of working with the Proxima team for over a year on overall regulatory strategy and support for FDA interactions. The entire Proxima team are unbelievably knowledgeable in this space with excellent communication skills, highly strategic thinking, and amazing customer service. We at Prenosis highly recommend them as a one stop shop for anything regulatory or clinical trial related, all offered at a very attractive price point.

CEO and Co-Founder

Bobby Reddy Jr.

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.

Physician

Chester J. Koh, MD

01.

Regulatory Strategy & Submissions

We define and build toward the right FDA pathway (IDEs, 510(k)s, De Novos, and PMAs for devices and diagnostics, INDs for therapeutics) and turn it into the regulatory narrative that strengthens a funding application.

02.

Clinical Operations & Study Startup

Our deeply involved Study Startup Specialists compress the timeline from award to enrollment, driving feasibility, site selection, and recruitment across a US network of specialized sites.

03.

Quality Systems & Compliance

Grant-funded work carries quality obligations. We help companies stand up and mature their QMS, prepare for audits, and build the infrastructure funders and regulators expect.

04.

Development Planning

We convert a research concept into a defensible clinical and regulatory development plan — the kind that signals to reviewers that funding will translate into progress.

How Proxima Supports
CPRIT Applicants & Awardees

From the strategy behind an application to the execution that follows an award, Proxima supports companies across the full arc of CPRIT-aligned development.

One partner across regulatory, clinical, and quality — available through fractional or full-service models that fit an early-stage company's stage and budget.

Why Companies Choose Proxima

Proxima was founded at the heart of the Texas Medical Center, the same Houston research ecosystem CPRIT was built to grow. That local relevance matters for a Texas-based program.

Our focus is the emerging innovators advancing novel science, not the established programs other CROs are built around. Early-stage and complex trials are our specialty.

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Hands-on study startup, established site relationships, and a specialized US site network shorten feasibility and recruitment timelines where early-stage programs most often lose time.

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(CHANGE TO ONCOLOGY FOCUS) Deep experience across medical devices, diagnostics, and SaMD/SiMD, and the regulatory pathways they require — critical for the AI/ML-driven tools emerging in cancer detection and care.

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