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Project Management
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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...
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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...
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European Medicines and Medical Devices: Future Trends
March 8, 2023
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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On-Demand Webinar: Natural History Study for Ultra-Rare Diseases
June 30, 2022
Were you able to join Veristat’s live webinar- “Strategies for Solving the Challenges of an Extraordinary Natural History Study – Navigating the Patient Experience When Pivoting to a Virtual Model Mid-Study”?
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Regulatory TOPRA Webinar: Latest Regulatory Experiences
June 15, 2022
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...
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Joining HIPRA to Take Aim at the Continuing Challenges of COVID-19
June 2, 2022
UPDATE – Veristat study collaboration with HIPRA leads to EMA approval of BIMERVAX® COVID-19 vaccine, the first bivalent recombinant protein vaccine to be authorized in the EU and the first human health vaccine to be designed and developed in Spain.
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A Paradigm Shift in Monitoring Clinical Trials
May 27, 2022
What we know as work has experienced a major transformation. This shift and the changes it precipitated have affected how we now conduct and perform monitoring of clinical trials.
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Is Your Complex NDA/MAA Submission Missing One of These Key Elements?
August 21, 2018
Veristat has experience in preparing more than 120 marketing applications. Our exposure to in creating new drug applications (NDAs) and marketing authorization applications (MAAs) has taught us two main lessons:
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Key Strategies for Overcoming Data Analysis Difficulties During NDA/MAA Submissions
August 14, 2018
When database locks are delayed, or regulatory agencies request additional analyses for new drug applications (NDAs) or marketing authorization applications (MAAs), it seems there is no alternative but to take a hit to the timeline — or is there?