Veranex

Overview

Veranex is positioned as the industry's first Innovation CRO (iCRO), consolidating product design, engineering, manufacturing, preclinical, clinical, regulatory, quality, and market-access expertise under one organization. The company serves over 700 global clients and has accelerated more than 1,000 programs, with approximately 800 cross-disciplinary experts across 15 international hubs.

Core Service Areas

Design & Development: Product design, software development, engineering, testing, prototyping, human factors, and manufacturing solutions.

Preclinical & Pathology: Non-GLP and GLP preclinical studies, pathology services, surgical and bioskills training, cadaver lab facilities, and dedicated preclinical facilities.

Clinical Research (CRO): Trial design, trial management, project management, study monitoring, safety management, data management, biostatistics and statistical programming, data visualizations, and medical writing.

Regulatory Consulting: FDA device consulting, MDR consulting, IVDR consulting, and EU authorized representative services.

Quality Consulting: Audit and inspection readiness, QMS consulting, design validation and quality, and special process validation.

Commercialization: Innovation and strategy, market and customer insights, access and reimbursement, HEOR consulting, and integrated evidence planning.

Therapeutic Expertise

Veranex maintains recognized leadership in cardiovascular, neurovascular, in-vitro diagnostics, and ophthalmology device development. The company also offers biopharma solutions and clinical trials support.

Biostatistics Capabilities

The biostatistics team includes regulatory statistics experts with EMA experience and publication expertise in high-impact journals (The Lancet, PLoS, PNAS). Services extend beyond conventional clinical trial statistics to measurement theory, psychometrics, and patient-reported outcomes (PROs) consulting.