New offerings combine a variety of Medidata technologies and learnings from thousands of previous trials to streamline study management for Phase II and Phase III studies in specified therapeutic areas, reinforcing FDA guidance for patient-centered study design and execution
NEW YORK--BUSINESS WIRE--
Medidata, a Dassault Systèmes brand and leading provider of clinical trial solutions to the life sciences industry, has introduced two new bundled offerings to meet the growing demands of oncology and vaccine research. Medidata Oncology Solutions and Medidata Vaccine Solutions reinforce the FDA guidance for patient-centered endpoints, adaptive trial designs, and trial diversity. By unifying key trial components such as real-time patient-reported outcomes and imaging management, these bundled solutions will aid sponsors by reducing trial complexity, accelerating decision-making, and improving assessments of treatment efficacy and safety.
"Oncology and vaccine trials face significant challenges in recruiting diverse patients, ensuring rapid execution, and maintaining and monitoring patient safety," said Joseph Schmidt, chief operating officer, Medidata. "By making these new bundled capabilities readily available to customers, we can deliver a solution built on Medidata's vast experience and expertise in these two important therapeutic areas. These bundles are designed to help customers navigate the complicated stages of these studies while advancing life-saving treatments."
Medidata, with more than 25 years of oncology and vaccine experience and the largest global trial datasets, has conducted approximately 9,000 oncology studies and 750 trials in vaccines. In 2023, it was recorded that 93% of oncology drug approvals went through Medidata. The company was also on the frontlines of COVID-19, supporting hundreds of trials, including the development of one of the most effective mRNA vaccines used to fight the virus.
Both solutions deliver a unified data ecosystem by integrating Medidata Rave EDC, Medidata eCOA, Medidata Rave Imaging, Medidata Clinical Data Studio, and Health Record Connect.
