Veristat is a global clinical research organisation and strategic consultancy that works with pharmaceutical, biotechnology and medical device companies to accelerate the development and approval of innovative therapies. Founded in 1994 and headquartered in the United States, the company provides integrated scientific, clinical and regulatory expertise designed to help sponsors navigate complex drug development challenges and bring new treatments to market efficiently.

Positioned as a “science-first” CRO, Veristat combines strategic planning, regulatory expertise and clinical trial execution to support drug and biologic programmes throughout the development lifecycle. The company specialises in supporting emerging and mid-sized biopharmaceutical companies developing complex or novel therapies, including treatments for rare diseases, oncology and biologics.

With more than three decades of experience, Veristat works closely with sponsors from early development planning through regulatory submission and post-marketing activities. Its multidisciplinary teams provide scientific insight, operational execution and regulatory guidance, helping clients design effective clinical studies, collect and analyse data, and prepare regulatory filings for authorities such as the FDA and EMA.

Key Products and Services

Veristat offers a broad portfolio of integrated services across the clinical development lifecycle, including:

• Clinical trial services: Full-service clinical trial design, management and execution across multiple phases of development.

• Regulatory affairs and strategy: Regulatory planning, agency interactions, and preparation of submission packages such as NDAs and MAAs.

• Biometrics and biostatistics: Statistical consulting, study design, data analysis and regulatory statistical reporting.

• Medical and regulatory writing: Development of clinical documentation, regulatory submissions and scientific communications.

• Pharmacovigilance and safety services: Monitoring and management of drug safety across the product lifecycle.

• Strategic consulting: Expert guidance to optimise clinical development strategies and regulatory pathways.

• Functional service provider (FSP) and resourcing solutions: Dedicated teams and specialist expertise to support sponsor development programmes.

Through its integrated clinical, regulatory and scientific capabilities, Veristat aims to help life sciences companies navigate the complexity of drug development and bring innovative therapies to patients faster. By combining deep technical expertise with a collaborative, science-driven approach, the company positions itself as a strategic partner for organisations seeking to advance complex treatments from early development through approval and commercialisation.