About Veristat
Specialty expertise for complex development
Our clinical, biometrics, and regulatory experts work from one plan, turning your data into clear direction so you can make confident decisions earlier in complex clinical trial programs.
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OUR PEOPLE
Scientists who solve problems
Our experts have spent 30 years on novel drug development. They work on rare diseases, cancers, and neurological disorders, including therapies never approved before.
Therapeutic depth
Rare and ultra-rare disease accounts for 35% of our work, with more than 350 trials and consulting projects in five years. Our experts supported the first gene therapy approved in Europe.
Biostatistics-led design
Our biostatisticians and data teams help shape the study before it starts, so the analyses that matter are planned long before database lock.
Senior-level access
Our experts do more than execute a plan. They weigh options, name the risks in each one, and tell you what they see.
Regulatory experience
More than 160 marketing applications prepared, leading to over 105 regulatory approvals.
More than Thirty Years of Growth Built Around Client Needs
Since 1994, Veristat has expanded its capabilities, expertise, and global reach to support complex development programs. From broadening services to establishing offices around the world and adding new areas of expertise, each milestone reflects how Veristat has grown alongside the needs of its clients.
HISTORY AND TIMELINE OF VERISTAT'S GROWTH
1994
Veristat founded by John and Barbara Balser
Offering strategy, biometrics and medical writing support
2011
Conduct first Clinical Operations services
2016
Expands into Europe
2019
Expands operations into Asia with Taipei Office opening
2021
Establishes offices in UK and Spain
2022
Adds Swiss Office
2023
Open offices in France and India
2026
Acquires Certara Regulatory Writing Capabilities
what makes us different
Built for complex programs
Complex development needs scientific judgment, not just capacity. Our experts work across strategy, biometrics, clinical operations, and regulatory so the decisions connect.
Global Expertise
Submission Experience
More than 2,000 clinical trials supported globally
160+
Marketing applications prepared
105+
regulatory approvals with FDA, MHRA, and EMA
Programs that reached approval
Complex development looks different in every program. These two show how design, data, and regulatory strategy came together to get a therapy approved.
Global Pediatric Full-Service Phase I/II Clinical Trial Begins on Heels of Successful Natural History Study
Veristat supported a mid-size biotech company developing a novel gene therapy for an ultra-rare pediatric neurological disease. Following a successful natural history study, the program advanced into a Phase I/II clinical trial, with Veristat providing full-service support across clinical development.
View the Case Study →
40+
Full-service biologics trials successfully conducted in the past three years
From regulatory strategy and biostatistics to site management and patient relocation, Veristat served as an extension of the sponsor team to advance an ultra-rare pediatric gene therapy program.
Supporting Global Approval of a First-in-Class Gene Therapy for a Rare Genetic Disorder
Veristat supported critical stages of development, from regulatory inspection readiness and clinical oversight to cross-functional coordination, ultimately advancing the program toward regulatory submissions in both the United States and Europe.
View the Case Study →
FIRST
Approved gene therapy for this rare genetic disorder
Through sustained clinical, regulatory, and cross-functional support, Veristat helped advance a first-in-class gene therapy through FDA and EMA inspections to successful approvals in the US and Europe.
Let's talk about your program
Tell us what your program needs to answer next. Our experts will walk through where the risk sits, whether that's design, data, delivery, or the regulatory path.
Frequently Asked Questions
Veristat combines global clinical development capabilities with deep scientific and regulatory expertise in complex development programs. Our teams have extensive experience in areas including oncology, rare disease, neurology, and cell and gene therapy, where specialized study designs, challenging patient populations, and evolving regulatory requirements demand a highly integrated approach.