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On the Ground at ISPOR 2023
Healthcare stakeholders gathered in Boston for ISPOR 2023 – the annual meeting to advance the science and practice of health economics and outcomes research (HEOR) around the world. Read insights and takeaways from the COTA team.
COTA, Inc. Expands Oncology Real-World Data Research & Consulting Services to Accelerate Safe, Effective Drug Development
COTA’s expanded services will provide even more support to organizations conducting research, like Bristol Myers Squibb, the US Food and Drug Administration, and Miami Cancer Institute. From protocol advisory and development to analytic and algorithmic support and publications, COTA’s expert guidance is a valuable asset for those looking to make advances in oncology research.
Building a better ECA: 5 steps for submitting an ECA to regulators
In this post we look at the future of RWD in action and explore the world of external control arms (ECAs). Experts outline 5 steps to building and submitting an ECA to regulators.
Sandy Leonard Joins COTA’s as Chief Commercial Officer to Lead Business Expansion Efforts
With over 20 years of pharmaceutical and real-world data experience, Sandy Leonard joins COTA as Chief Commercial Officer. Sandy will lead COTA’s business expansion efforts, focusing on life sciences’ growth strategy and prioritizing customer success and experience.
Real-world data control arm provides new look into effectiveness of lymphoma therapies
Real-world data can uncover vital efficacy info for new treatments. In the development of an external control arm for lisocabtagene maraleucel in patients with R/R large B-cell lymphoma, Bristol Myers Squibb used COTA’s RWD.
What to know about FDA draft guidance on accelerated approval of oncology drugs
Are you up to date with the latest FDA guidance on accelerated approvals for oncology therapeutics? The FDA has just released draft guidance on the use of randomized controlled trials (RCTs) versus single-arm trials for the accelerated approval of oncology therapies. We’ve broken down what you need to know.
