Posts about
Project Management
On-Demand Webinar: Single-Arm Studies for Use as a Registrational Study in Oncology
Single-arm clinical trials are gaining attention as potential registrational studies in oncology...
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...
European Medicines and Medical Devices: Future Trends
Based on an online seminar presentation made in collaboration with TOPRA and Veristat, this article...
On-Demand Webinar: Natural History Study for Ultra-Rare Diseases
Were you able to join Veristat’s live webinar- “Strategies for Solving the Challenges of an...
Regulatory TOPRA Webinar: Latest Regulatory Experiences
Each year, Veristat regulatory experts present timely, relevant topics to members of The...
Joining HIPRA to Take Aim at the Continuing Challenges of COVID-19
UPDATE – Veristat study collaboration with HIPRA leads to EMA approval of BIMERVAX® COVID-19 vaccine
A Paradigm Shift in Monitoring Clinical Trials
What we know as work has experienced a major transformation. This shift and the changes it...
Is Your Complex NDA/MAA Submission Missing One of These Key Elements?
Veristat has experience in preparing more than 120 marketing applications. Our exposure to in...
Key Strategies for Overcoming Data Analysis Difficulties During NDA/MAA Submissions
When database locks are delayed, or regulatory agencies request additional analyses for new drug...