Regulatory Teams

Create Compelling Regulatory Submissions

Use COTA data and research expertise to design effective studies and support your treatment’s regulatory submissions.

Design More Effective Trials

In addition to high-quality, cancer-specific data, COTA offers support services to help you design your trials, control arms, or comparator arms in the most effective way possible.

Strengthen Your Evidence with COTA

COTA’s cancer-specific data, compliant with 21 CFR Part 11, helps regulatory teams:

Improve Entry Documentation

COTA’s expertise in research design, analysis and high-quality data have been used to support successful submissions to both the FDA and EMA.

Real-World Evidence for Real-World Results

Access the Highest-Quality Oncology Real-World Data

Focus is perfect for regulatory teams looking to support their regulatory submissions for a specific cancer treatment. Focus provides regulatory-grade patient data that is curated for your specific use case and can be used to supplement clinical trial data and construct ECAs.

Real-World Insights and Support is an optional, complementary add-on service that adds personalized expertise and support to your data. Our clinical and statistical experts work either as clinical advisors or as the execution arm of your team (depending on the data you choose), to provide statistical analysis and streamline study designs.

Access COTA for your Regulatory Team

Contact COTA to learn more about solutions for cancer regulatory teams.