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4 min read

Regulatory Guidance Monthly Review - August 2023

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...

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1 min read

Exploring Future Trends on European Regulations: A Webinar by Veristat and TOPRA

Veristat, in partnership with TOPRA, recently hosted an insightful webinar titled "Future Trends on European Regulations on Medicines." This webinar provided valuable updates on the new Pharmaceutical Strategy for Europe and its impact on the regulatory...

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4 min read

Regulatory Guidance Monthly Review - July 2023

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...

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1 min read

Unlocking Insights: The Impact of New Medical Device EU Regulation (MDR)

Veristat and TOPRA recently hosted an informative webinar on the topic of the impact of new EU regulations on the development of medical devices and drug combination products. The European Commission's adoption of Regulation (EU)

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1 min read

Biosimilar FDA Meeting Types

It is crucial for biosimilar developers to engage early and often with FDA to ensure the health authority is well-informed and supports your planned development path. Regulatory meetings and interactions provide sponsors the opportunity to receive...

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2 min read

Strengthening Opportunities for Growth in the European Region

With the recent changes in clinical trial regulations and the growth of clinical trials in Europe, Veristat continues to build its footprint in the European region. Veristat’s VP of Europe, Montserrat Barcélo Riera, recently spoke to Annelot Huijgen of...
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2 min read

On-Demand Webinar: Single-Arm Studies for Use as a Registrational Study in Oncology

Single-arm clinical trials are gaining attention as potential registrational studies in oncology research. This webinar provides an overview of single-arm trials, their foundations for registration, and regulatory strategies associated with the US...
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3 min read

Regulatory Guidance Monthly Review - June 2023

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...

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The Influence of MDR’s Article 117 in the Marketing of Combination Products

The European Union Medical Device Regulation’s (MDR) Article 117 brings improved patient safety measures with new implications for manufacturers, as they must fulfill a significant set of additional requirements.

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1 min read

Migration of Data Between EDCs

Factors such as ongoing industry consolidation, continual regulatory change, rapid technology evolution, and unending cost-cutting are causing organizations to consider replacing or upgrading their existing Electronic Data Capture (EDC) solution.

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