Accelerate positive outcomes in cancer trials: Veristat's proven strategies
The number of cancer cases is on the rise worldwide. It is expected to increase by 77% from 20 million in 2022 to 35 million in 20501. It’s no surprise that oncology is the most active therapeutic area in clinical trials globally, as more resources than ever are being dedicated to developing and testing new cancer treatments. The 6,528 oncology trials expected to wrap up this year far exceed the next therapy area of central nervous system treatments, of which 4,043 trials are expected to be completed this year2. This month, Veristat is showcasing how we have helped clients accelerate positive outcomes in cancer trials, resulting in less work for sponsors and more hope for patients. Learn more >
1World Health Organization (WHO), 2GlobalData Pharma Intelligance Center
Webinar: Align New Oncology Therapies with FDA's Project FrontRunner
In partnership with Clinical Leader, Veristat consulting, regulatory, and clinical experts gave a live webinar outlining how to advance new cancer therapies in alignment with FDA’s Project FrontRunner. Watch to understand better what Project FrontRunner is and why now, when it makes sense to offer patients earlier investigational therapy options, what the trial design considerations/implications are, and how it impacts patient safety and site participation.
Case Study Vignette: Strategic Clinical Consulting Oncology
From positioning an immuno-oncology antibody trial for success to supporting FDA and EMA approvals for an ultra-rare blood cancer biologic, our early, forward-looking planning can result in greater efficiency and a better understanding of key decisions and time points during your novel therapy development. Veristat regulatory, clinical, medical, and statistical consultants provide high-level strategic consulting services from IND planning to regulatory approval. Learn more >
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Case Study Vignette: Global End-to-End Regulatory Excellence
From preparing and writing clinical trial applications (INDs/CTAs/IMPD) to publishing all clinical trial and regulatory dossiers/applications to regulatory agencies, Veristat offers global regulatory excellence throughout the clinical development lifecycle. Explore how Veristat has helped sponsors achieve regulatory success globally and learn how our expertise can be tailored to support your specific needs. Learn more >
Blog: Understanding FDA's Project Optimus
Project Optimus is an initiative from the FDA Oncology Center, established to educate, innovate, and collaborate with the oncology community, including companies, academia, professional societies, international regulatory authorities, and patients, to advance a dose-finding and dose-selection paradigm that emphasizes the selection of an optimal dose (or doses) in the pre-market setting. Learn more >
Blog: Webinar Q&A: How to Advance New Cancer Therapies Using FDA Project FrontRunner
After an engaging Q&A session was cut short due to time restraints during the live webinar (linked above), we gathered all the questions and had our speakers answer each in detail. Read to take a deeper dive into leveraging the FDA’s ProjectRunner to set up your new cancer clinical project for success. Learn more >