RxTROSPECT Oncology Analytics

RxTROSPECT is a regulatory precedent identification tool that provides extensive analytics on US FDA and EU EMA oncology approvals (original approvals and follow-on indications). ➤ Who is RxTROSPECT for? Drug development teams who are planning oncology development strategies and need to: • De-risk regulatory strategy through easy to access regulatory precedent. • Plan future discussions with the FDA and global health authorities on strategy, trial design, unmet medical need and scientific advice. • Enhance their understanding of how drugs are approved in the US and Europe and the nuances that come with that. • Enhance their overall regulatory intelligence offering. ➤ Why is RxTROSPECT valuable? Our users (from top 10 oncology companies to pre-revenue biotech) all report saving tremendous amounts of time in precedent identification, enabling them to focus on assessment and strategy. We have a renewal rate of >90% over the past five years which shows the value our users are seeing in the tool and its offering. ➤ What does RxTROSPECT reveal? Precedent on indication, study design, pivotal study phase and size, regulatory pathways, key efficacy and safety data for all oncology approvals (original approvals and new indications). ➤ How can I access RxTROSPECT? Visit rxtrospect.com or email us at theteam@rxtrospect.com to learn how RxTROSPECT users are leveraging our solution to expedite development of informed regulatory strategies and, ultimately, drug development strategies.