ABOUT VERISTAT

Veristat, a global clinical research organization (CRO), enables sponsors to solve the unique and complex challenges associated with accelerating therapies through clinical development to regulatory approval. With more than 26 years’ experience in clinical trial planning and execution, Veristat is equipped to support any development program. 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.

CAPABILITIES

Getting a novel therapy through the clinical development process to approval is complicated, full of challenges, and even more complex in the current COVID-19 world. Learn how to advance your novel  medical therapies from Phase I-III clinical development to market with confidence,

Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.

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.

Expertise that accelerates therapies for rare and ultra-rare disease through the clinical development process.

Quality medical writing of clinical trial documents, safety updates, and marketing applications for regulatory success

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

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

CONTACT INFORMATION

Veristat, Inc.

134 Turnpike Road, Suite 200

Southborough, MA 01772

UNITED STATES

Phone: 508-306-6281

Contact: Lauren Willis

FEATURED ARTICLES

  • The recent FDA guidance titled, Human Gene Therapy for Neurodegenerative Diseases (ND) provides recommendations for Sponsors who are developing human gene therapy (GT) products for neurodegenerative diseases, which affect adult and pediatric patients. It focuses on considerations for product development, preclinical testing, clinical trial design and marketing approval pathways. This article outlines several areas to consider when preparing for regulatory agency interactions.

CASE STUDIES

  • A mid-size pharmaceutical company and its development partner, a small biotechnology company engaged us to complete the medical writing for their product’s Marketing Authorization Application (MAA), New Drug Application (NDA), and New Drug Submission (NDS). Learn how our medical writing team worked closely with the sponsors to write these marketing applications in an accelerated timeline.

  • A mid-sized biopharmaceutical company dedicated to developing innovative therapies for patients with debilitating rare diseases acquired the rights to a new investigational drug from a large pharmaceutical company with the intention of preparing the data for a Marketing Authorization Application (MAA). Learn how our team had to think creatively to enter, clean and standardize the clinical trial data from previous and ongoing trials in order to get the MAA ready for submission in an extremely short timeline.

  • At the onset of the COVID-19 pandemic response, our current client needed help to kick-off a phase I vaccine trial. The sponsor had identified sites and patients and the gating factor was to get the clinical trial database built quickly in order to start enrollment and randomization.  Learn how we helped our client design and launch their clinical trial database in two weeks' time, with patient randomization beginning the day of launch.

  • Veristat was brought in to create and manage a full development program for a gene therapy for a very rare inherited disorder. The work involved charting the course in completely uncharted waters – our team had to create industry best practices that didn’t exist before, anywhere. With no classic route to market, Veristat’s experts wrote the map on patient recruitment, regulatory and health agency engagement, natural history studies and the Central Site Model.

  • A long-term client called upon the Veristat team for help conducting two investigational Phase I/II studies. These global studies focused on proving the safety and efficacy of gene therapy for two rare genetic disorders. Working side-by-side with the client, our cell and gene therapy experts addressed many complicated challenges – including site start-up issues, stringent regulatory requirements, and the logistics of handling highly sensitive genetic material.

  • A clinical-stage biotechnology start-up asked Veristat to run a new European trial of their complex gene therapy. Veristat experts complimented the client’s team taking on their first clinical-stage program. Our global cell and gene therapy team brought knowledge in genetic material handling, relationships with key global regulatory agencies, and expertise in accelerated pathways to approval.

WEBINARS

  • In this webinar experts explore how to develop your marketing application strategy, analyze the benefits and risks associated with your data migration strategy and coordinate with the medical writing team so that all the information needed to write and complete the modules of the submission is provided with adequate time for review and quality control.

  • Submitting an Investigational New Drug (IND) application to the US FDA is a significant step in the development of a new drug or biologic product. But, are you ready? In this webinar, experts explore the minimum required content for an IND submission and the strategic considerations for developing more than the minimum necessary data before filing an IND.

  • Nothing is standard about the study design, study conduct or the regulatory process in cell and gene therapy trials. Every cell and gene therapy is different due to the specific characteristics of each product, with a complicated regulatory approval process and unique therapeutic challenges. In this webinar, participants will learn an end-to-end approach to bringing a cell and gene therapy to market.

WHITE PAPERS