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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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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 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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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...
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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...
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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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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...