Medidata Introduces Oncology and Vaccine Solutions to Streamline Phase II and III Trials with FDA-Aligned Patient-Centric Design

05 November 2024 | Tuesday | News


Leveraging 25+ years of expertise, Medidata’s new integrated solutions aim to simplify trial management, enhance patient diversity, and support rapid, adaptive study designs for oncology and vaccine research.

The new products combine Medidata's diverse technologies and experience from thousands of previous trials to streamline the management of Phase II and Phase III studies in specific therapeutic areas and reinforce FDA guidance on patient-centric study design and execution

 

Medidata, a Dassault Systèmes brand and a leading provider of clinical trial solutions for the life sciences industry, has launched two new integrated solutions to meet the growing needs of oncology and vaccine research. Medidata Oncology Solutions and Medidata Vaccine Solutions reinforce FDA's guiding principles for patient-centered endpoints, adaptive trial design, and trial diversity. By unifying key trial components such as patient-reported outcomes and imaging management, these integrated solutions will help sponsors reduce trial complexity, speed decision-making, and improve assessment 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. By making it easy to offer these new integrations to our clients, we can deliver solutions that build on Medidata's extensive experience and expertise in these two important therapeutic areas." These integrated capabilities are designed to help clients navigate the complex phases of these studies while advancing life-saving therapies. ”


Joseph Schmidt, Chief Operating Officer of Medidata, said, "Oncology and vaccine trials face significant challenges in recruiting diverse patients, ensuring rapid execution, and maintaining and monitoring patient safety. By making it easy to offer these new integrations to our clients, we can deliver solutions that build on Medidata's extensive experience and expertise in these two important therapeutic areas." These integrated capabilities are designed to help clients navigate the complex phases of these studies while advancing life-saving therapies. ”

Medidata has more than 25 years of experience in oncology and vaccines and the largest global trial data set, with approximately 9,000 oncology studies and 750 vaccine trials conducted. For the record, in 2023, 93% of oncology drug approvals were made through Medidata. The company is also on the front lines of the fight against the virus, supporting hundreds of trials, including the development of one of the most effective mRNA vaccines to fight the coronavirus.

The two solutions integrate Medidata Rave EDCMedidata eCOAMedidata Rave ImagingMedidata Clinical Data Studio and Health Record ConnectProvide a unified data ecosystem. To learn more about Medidata's new integrated oncology and vaccine solutions,

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