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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...
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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...
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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...
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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...