Proxima Clinical Research

Overview

Proxima Clinical Research is a clinical research organization headquartered in Houston, Texas, serving 300+ clients across 35+ therapeutic and industry segments. The organization combines clinical, regulatory, and quality expertise to support life science companies from early-stage development through commercialization.

Core Services

Regulatory Affairs: Expertise in FDA device pathways (Q-sub, IDE, 510(k), PMA, De Novo, HDE, CE Mark) and drug pathways (IND, NDA, BLA, 505(b)(2), RMAT). The team provides guidance on regulatory strategy and submission preparation.

Clinical Solutions: Agile clinical trial processes supported by leading experts and technology platforms. The organization has enrolled 5,000+ patients and offers clinical solutions designed to meet sponsor timelines and requirements.

Quality Management: Support for quality system implementation, including SOP development, eQMS installation, audit preparation, and manufacturer audits.

Data & Commercial Solutions: Partnerships with data aggregators provide access to EMR, laboratory results, claims, remits, charge master, and specialty pharmacy data to support commercial teams.

Workplace

Proxima is a Great Place to Work® certified company headquartered in Houston with remote-friendly operations. The organization emphasizes innovative projects, professional development, and employee well-being.