ConcertAI Releases CTO 2.0, a Next Generation Offering to Support Clinical Trial Design and Execution

CAMBRIDGE, Mass., April 5, 2023 – ConcertAI, LLC (ConcertAI), a leader in AI Software-as-a-Service (SaaS) technology and Real-world Evidence (RWE) solutions for life sciences and healthcare, today announced the release of its CTO 2.0 solution for clinical trial optimization.

CTO 2.0 is the next generation of ConcertAI’s CTO solution, now including three notable new features: expanded data assets through publicly available sources to include site and physician level trial information on current and previous clinical trials; in collaboration with data partners, working operational trial metrics and site profile information to highlight trial performance and site capabilities; and social determinants of health information at both the physical site and physician/patient levels. The latter encompasses data points such as education, economics, race, and gender characteristics.

With this new information, CTO 2.0 will soon be able to provide recommendations that automate the site selection process using a data-driven approach. The SaaS technology will support researchers and clinicians in selecting the most appropriate sites for clinical trials, balancing potential patients available and previous trial performances at those sites to give the highest likelihood of success for a clinical trial.

CTO 2.0 also supports trial operators in complying with the FDA mandate that clinical trials should provide meaningful information for the outcomes of the populations who will ultimately receive approved medicines. As a direct result of this guidance, there’s an increased need for community-based trials and improved trial designs to limit the burden on community trial settings. Beyond being able to identify sites for potential trials based on social determinants of health and incidence rates, CTO 2.0 leverages the latest clinical informatics integrations and data standards to ensure research can be conducted at scale and meeting, or exceeding, enhanced standards of care.

“There is a practical and moral imperative to make clinical trials available to all patients, which naturally means expansion of trials into community settings, where over 75 percent of patients receive their care. This aligns with the FDA mandate, and also with the urgent necessity to increase trial diversity. CTO 2.0 is a direct response to these needs,” said Ronan Brown, PhD, ConcertAI’s COO. “Legacy trial designs must change. We’ll now see greater reliance on specially prepared datasets that allow multiple trial goals to be achieved – such as designing a trial based on data from the specific, most affected population, or ensuring a trial will be executable in a community setting – without increasing the burden on researchers. It’s a significant step forward in clinical trial development and operation.”

To learn more about ConcertAI’s vision for the future of clinical trials, see here:

About ConcertAI

ConcertAI is a leader in Real-World Evidence (RWE) and AI technology solutions for life sciences and healthcare. Our mission is to accelerate insights and outcomes for patients through leading real-world data, AI technologies, and scientific expertise in partnership with the leading biomedical innovators, healthcare providers, and medical societies. For more information, visit us at