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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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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
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
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
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...
Comparability studies are a significant issue for those working in biotherapeutics development, as undetected product changes are considered high risk.
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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,...
4 min read
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 development of biosimilar products in the U.S. has progressed since the regulatory pathway was established as part of the Affordable Care Act. Since then, the number of active biosimilar development programs has risen steadily. The market for these...
Drug developers hire regulatory consultants and CROs to help navigate the complex regulatory agency requirements and interactions throughout the development lifecycle. While most Sponsors understand the role of a Regulatory Strategist, fewer have...