1750 Washington Street
A strikingly distinct Clinical Research Organization (CRO), Veristat stands alone in combining industry-leading expertise with an unwavering commitment to scientific integrity and a renowned focus on client satisfaction. Long-lasting client relationships are our hallmark, because we consistently provide timely, accurate and efficient clinical research services.
Located in the greater Boston Metro area, Veristat is an innovative, science-focused CRO with nearly twenty years of dynamic expertise in supporting clinical trials and regulatory submissions for pharmaceutical, biotechnology, and medical device companies. A privately owned, full-service CRO founded by John Balser, PhD and Barbara Balser, VMD, Veristat offers comprehensive clinical development services for a single study or an entire clinical program. Our services include:
• Data management (EDC & Paper);
• Biostatistics & Statistical Programming;
• CDISC clinical data standardization;
• Medical writing;
• Clinical monitoring;
• Project management;
• Regulatory submissions strategy and preparation;
• FDA representation; and
• Strategic consulting
We have the expertise, experience, technical skills and resources to support a single study or an entire clinical development program. Over the past two decades Veristat has amassed proven expertise for designing, executing, analyzing, standardizing, and reporting clinical studies. From pre-trial regulatory guidance and strategy, to Phase I-Phase IV study conduct, to regulatory submissions, we have participated in over 600 studies across a broad spectrum of therapeutic areas, including extensive experience in the in the areas of oncology, genetic disorders, rare and orphan diseases, vaccines, anti-infectives, pain management, women’s health, and gastrointestinal disorders, to name a few.
In addition, Veristat has been instrumental in the production of over 20 successful and pending New Drug Applications (NDA and sNDA) and Biologic License Applications (BLA), including production of pivotal Phase 3 clinical study reports, integrated summaries of safety and efficacy, and the critical clinical summary documents and clinical overview for both US and EU submissions. Veristat has also represented nearly 40 different pharmaceutical and biotechnology companies in direct FDA and EU regulatory interactions, primarily on-site at regulatory agencies, and participated as statistical and clinical experts for advisory panel meetings, including acting as the client statistical representative for many of these panels.
Veristat was founded upon the belief that clinical research is fundamentally a scientific endeavor, and that the basic tenets of science must be followed to ethically and validly design, conduct, manage, analyze and report the results of clinical studies. We take pride in science; and our employees’ commitment to this idea is a key reason why we have successfully completed many hundreds of clinical studies and have had so many successful and long-lasting client relationships. Unlike many CROs, we remain a relatively small company by design. And our sensibly controlled size—not too big, not too small—offers many advantages to our clients, including our ability to integrate ourselves into our clients’ internal teams; our capacity to make rapid, flexible business decisions; the involvement of our incomparable senior management team; and our naturally collaborative, frank and transparent communication style.