Veristat, the Science-First™ full service CRO and consultancy, enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development onto regulatory approval and post-marketing. With our focus on novel drug development and 30 years of experience in clinical trial planning and execution, we deliver bold approaches that make the impossible possible. Our team has prepared over 100 marketing applications for approval with global regulatory authorities in the last 10 years alone. We supported the trials for the first gene therapy approved in Europe.

Veristat’s focus on novel drug development has led to success when handling the unknowns that arise across complicated therapeutic areas, such as rare/ultra-rare disease, advanced therapies, oncology, and infectious disease trials. We apply this knowledge base every day to solve any clinical program’s challenges, from the simplest to the most complex. Veristat has assembled an extraordinary team of experts worldwide who have mastered therapeutic development intricacies, enabling sponsors to succeed in extending and saving lives.

Whatever the study’s unique considerations – patients, products, process, follow-up, regulatory – Veristat can successfully get you through it. For more information, visit www.veristat.com.


Advancing biologics from start to finish is highly complex and full of challenges, requiring scientific strategies and implementation.

For successful regulatory outcomes, we provide quality medical writing services for clinical trial documents, safety updates, and marketing applications.

Applying experience, knowledge, and insights to plan and implement regulatory strategies for successful interactions with the FDA, MHRA, EMA, and other Global Regulatory Agencies.

Preparing regulatory marketing applications to their successful conclusions is our focus.

Getting a novel therapy through the clinical development process to approval is complicated. Unearth how to advance novel medical therapies from Phase I-III clinical development to market with confidence.

From regulatory pathway selection to patient recruitment challenges to navigating the volume of data to collect and clean — a rare disease therapy requires an extraordinary amount of coordination.

Infectious diseases are a threat to global health and way of life everywhere. Time is of the essence when it comes to developing safe and effective infectious disease vaccines and treatments. 

When the complexities of designing and executing cancer trials in a highly competitive market can mean delays in delivering urgently needed treatments to patients, it pays to have a trusted partner by your side.

Metabolic and endocrine diseases are a rising therapy area focus for clinical research due to the high demand for novel therapies that are challenged with proving safety and efficacy.

Second, only to Oncology, CNS, and Neurology clinical trials are incredibly complex and complicated to navigate.

Developing a therapy for a rare or ultra-rare disease is life-changing work with unique challenges. Examine how natural history data is being used to inform the clinical development process.

Strategic product development and CMC regulatory planning start early on at the pre-IND stage and apply to the entire development lifecycle through to post-approval.

Start early and get it right the first time. Course correct with a changing landscape. Overcome obstacles within clinical development. Collaborate with the best strategists and problem-solvers in clinical development.

Whether you need a few scientific experts or a fully-staffed function, gain flexibility and results with Veristat’s Strategic Resourcing Solution and confidently meet your study milestones.

Advancing a novel therapy through clinical development is complicated. Not all therapies make it to the patients that need them.

Accelerate your cell or gene therapeutic to market with tailored clinical and regulatory strategies and expert insights.

We understand how challenging it is to adopt a novel approach to drug development. Pivoting to virtual clinical trials is no exception.

Delivering safety surveillance before and after regulatory approval for pre-approval and marketed health products.


  • Listen in as Shaheen Limbada, Executive VP of Innovation and Strategy at Veristat, talks about virtual trial tools and strategies to increase efficiencies and save sponsors time and costs in DCTs.

  • Comparability studies are a significant issue for those working in biotherapeutics development. Consider these factors when playing the comparability game in biotherapeutics development.

  • While improving patient safety measures, learn how MDR’s Article 117 is causing implications for manufacturers, as they must fulfill a significant set of additional requirements.

  • When developing a new therapy for a rare disease, learn why a thoughtful, strategic approach early in the development process supports a well-designed study and agreement to your approach from regulatory authorities.

  • Listen as members of Veristat’s regulatory team bring to light the invaluable contributions and responsibilities of the Regulatory Project Manager, known for their problem-solving mindset.

  • Listen as members of Veristat’s Regulatory team delve into the analytical and clinical science of biosimilars and their regulatory pathway.  

  • In this podcast, Kevin Hennegan, Veristat’s Director of North American Regulatory Affairs, takes us through the many nuances key to the success of an Emergency Use Authorization application.

  • Hear members of Veristat’s Regulatory team guide listeners through several publishing best practices to consider when planning your marketing application. 

  • Listen as members of Veristat’s regulatory team outline the fundamentals— and the pitfalls— as you determine your readiness to file an Investigational New Drug (IND) from a manufacturing perspective.

  • Listen as members of Veristat’s regulatory team shed light on orphan drug designation classifications and the strategic use of subsets in study design.

  • Listen as Rachel Smith, Portfolio Director at Veristat, reviews considerations for setting up Natural History studies and the value they bring to rare and ultra-rare clinical research, despite the challenges in their design.

  • Listen as we replay some of Ewan Campbell’s insights from a recent webinar where Ewan provides a historical recap of the approved cell and gene therapy treatments over the past decade along with insights on where we are headed.

  • Listen to several key considerations for the deployment in cell and gene therapy studies including the appropriate execution of PROs.

  • Administering advanced therapy products during a clinical trial can bring about many unique circumstances. Listen as Rachel Smith discusses Convection Enhanced Delivery (CED) which delivers medicines directly into the brain. Learn how to prepare for its challenges and what it can mean for patients, clinical teams, and sponsors.

  • Listen as Ewan Campbell, Advanced Therapy and Biotech Director for Veristat outlines some of the unique challenges faced when developing advanced therapies and shares some of his experience gained in neurodegenerative disease studies over the past 20 years.

  • Identify some of the key components of a cell & gene therapy marketing application with an industry expert who outlines the most common pitfalls and gaps he has encountered with sponsor applications.

  • The pros, cons and future of allogeneic versus autologous therapies are explored as Rachel Smith, Portfolio Director for Veristat, shares her observations on the impact of these techniques on advanced cell-based therapies and what the next decade may hold.

  • Rachel Smith, Portfolio Director for Veristat, discusses the three types of post-marketing requirements that can be requested by the EMA and draws upon the recently approved therapies – Tecartus, Zolgensma and Libmeldy, Skysona and Abecma– for real-world context.

  • Robin Bliss, PhD, and VP of Strategic Consulting for Veristat, takes us through the how-to’s of selecting appropriate endpoints for an early phase study, the importance of considering endpoints in the context of clinical meaning, and the value of ensuring that endpoints are measurable within a reasonable amount of time.

  • Mariana Oviedo, Project Manager for Veristat, provides an overview of the key items that must be taken into consideration when designing and running a long-term follow-up study for a gene therapy product.

  • Hear from Rachel Smith, Portfolio Director for Veristat, as she uses our recent work with a biotech company to illustrate the importance of a comprehensive shipping and traceability strategy, tight management of the patient journey, and adoption of a well-conceived protocol and process documentation to support the commercialization strategy.

  • Rachel Smith, Portfolio Director for Veristat, takes us through a number of pitfalls to avoid when planning a gene therapy study. With the stakes high and having conducted trials for the first gene therapy approved in Europe, put Rachel’s lessons learned to work when determining your regulatory pathway, logistics strategies and donor screening requirements.

  • Listen as Kevin Hennegan, Senior Regulatory Strategist for Veristat, shares some of the common hurdles drug developers face when bringing cell therapies to market including international regulatory variability, patient safety assurance, planning for long-term follow-up and more.


Veristat, Inc.

134 Turnpike Road, Suite 200

Southborough, MA 01772


Phone: 508-306-6281

Contact: Lauren Willis