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On-Demand Webinar: Single-Arm Studies for Use as a Registrational Study in Oncology
July 14, 2023
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...
3 min read
Regulatory Guidance Monthly Review - June 2023
July 6, 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...
The Influence of MDR’s Article 117 in the Marketing of Combination Products
July 5, 2023
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.
1 min read
Migration of Data Between EDCs
June 28, 2023
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.
1 min read
Successful Full-Service, Randomized Pancreatic Cancer Phase II Trial
June 22, 2023
Learn how Veristat’s multidisciplinary team was able to work with the sponsor to solve challenges across numerous areas of this full-service phase II cancer trial. Collaborative efforts led to the sponsor decided not to close the Phase II study upon the...
2 min read
How does Real-World Evidence Impact Medicinal Product Development in Europe?
June 21, 2023
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...
5 min read
Regulatory Guidance Monthly Review - May 2023
June 15, 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...
1 min read
The Rise of Decentralized Clinical Trials: Transforming Research Through Technology and Patient-Centricity
June 6, 2023
Learn how decentralized clinical trials (DCTs) are reshaping the clinical research landscape. Explore the insights shared by Shaheen Limbada, EVP of Innovation and Strategy at Veristat as he discusses the lessons learned from the pandemic, the role of...
Apples to Apples: Playing the Comparability Game in Biotherapeutics Development
May 23, 2023
Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk.