Blog | Veristat, The Science-First CRO

2 min read

How does Real-World Evidence Impact Medicinal Product Development in Europe?

Explore the growing role of Real-World Evidence (RWE) in the regulatory decision-making process for medicinal products in Europe. Learn how RWE is reshaping the development landscape, its potential benefits, and the challenges associated with its...

1 min read

Understanding FDA's Project Optimus

Project Optimus is an initiative from the FDA Oncology Center of Excellence led by Drs. Mirat Shah and Atik Rahman.The goal of the initiative is to educate, innovate, and collaborate with the oncology community- including companies, academia,...

2 min read

FDA Introduces New Term "Nonclinical Tests" Signaling a Beginning, Not an End

For the past 60 years, US law has empowered the FDA to require that clinical trial sponsors submit data from “preclinical tests ” to prove their drug is safe enough to advance to testing in humans. At the close of last year, Food and Drug Omnibus Reform...

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European Medicines and Medical Devices: Future Trends

Based on an online seminar presentation made in collaboration with TOPRA and Veristat, this article dives into the future of the European medicines and medical devices industry and the changes in legislation that are being prompted by the evolving...

1 min read

Planning the Way Forward for a New Tumor Evaluation Modality

RECIST (Response Evaluation Criteria in Solid Tumors) guidelines were introduced over twenty years ago to provide a standard for evaluating tumor response, with the goal of maintaining consistency at sites and across sites as well as limiting any site...

1 min read

On-Demand Webinar: Natural History Study for Ultra-Rare Diseases

Were you able to join Veristat’s live webinar- “Strategies for Solving the Challenges of an Extraordinary Natural History Study – Navigating the Patient Experience When Pivoting to a Virtual Model Mid-Study”? 

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Regulatory TOPRA Webinar: Latest Regulatory Experiences

Each year, Veristat regulatory experts present timely, relevant topics to members of The Organization for Professionals in Regulatory Affairs (TOPRA), a UK-based organization committed to driving regulatory excellence across the healthcare regulatory...

1 min read

Is it Possible to Gain Regulatory Approval Following a Single-Arm Study?

In this case study example - yes.

Veristat developed a thorough regulatory submission strategy and novel efficacy endpoint for the treatment of an ultra-rare and aggressive hematologic malignancy that led to FDA and EMA approval following a single-arm...

4 min read

Planning the Way Forward in Neurodegenerative Disease Studies

Clinical trials involving gene therapies for the treatment of Central Nervous System (CNS) indications are some of the more complex in the field of gene and cell therapy (G&CT) development. During the lockdown, the Food and Drug Administration (FDA)...

3 min read

Clinical Trial Conduct During COVID-19 Pandemic Response

Key Lessons Learned during the First Month of the COVID-19 Pandemic Response 

As we are well-rooted in the response phase of the COVID-19 pandemic, we have seen a flurry of sponsors looking through their pipelines to find either approved or...