Planning Ahead Reduces Your Risk: Prepare Early for Your IND/CTA
Transitioning from pre-clinical activities into clinical trials is an important milestone in the lifecycle of your therapy. Learn how early planning for your IND/CTA can reduce your risk of a clinical hold.
Infographic: Similarities and Differences Between the CTA and IND
It’s often said that the Clinical Trial Application (CTA) is the European equivalent of an Investigational New Drug (IND) application. Our Infographic provides a simplified comparison for a better understanding as you establish the goals of your development program.
Infographic: Why and When to Hold a Pre-IND Meeting with FDA
The advantages are numerous and all point to limiting risks and ensuring FDA concurrence with your clinical development plan. Review our infographic to evaluate the benefits.
Article: Comprehensive Strategic Clinical Development Consulting
Using real-world examples, Robin Bliss, Vice President, Strategic Consulting for Veristat, provides a comprehensive overview of the processes involved in the formation and execution of clinical development plans intended to reduce financial burdens, save time, and find the shortest path forward.
Blog: Understanding When to Submit an IND Application to the FDA
“When your proof-of-concept data, clinical strategy, and funding begin lining up, it’s time to get serious about your regulatory strategy.” Get real-world insights and practical application tips from Kevin Hennegan, Director, North American Regulatory Affairs for Veristat, as you prepare for your IND activities.
Veristat experts have prepared over 80 INDs/CTAs in the past 3 years. Our deep experience helps sponsors identify issues, pinpoint opportunities, and implement time and cost-saving statistical and regulatory strategies.
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