Integrated Evidence
Medidata AI Integrated Evidence connects historical data from more than 23,000 cross-sponsor clinical trials and 7 million patient volunteers with real world data to deliver powerful insights and the necessary evidence clinical development leaders need to increase the probability of trial success.
Artificial intelligence and data can help fuel new ways of working on clinical trials and beyond.
Clinical Trial Data Informing Today’s Trials
Develop Powerful Insights
Medidata AI offers the world’s largest source of cross-sponsor, historical clinical trial data – made up of more than 23,000 trials, 7 million patients, and pre-integrated real world data (RWD) to offer solutions that give you the best chance of trial and regulatory success. Especially in a rapidly evolving clinical development landscape where RWD alone can often fall short in providing the insights and evidence necessary for your clinical development programs.
Increase probability of trial success
Medidata AI’s data, insights, and expertise give clinical development leaders and their trials the best chance at success – from a better designed trial, to a more scientifically-rigorous Synthetic Control Arm® (SCA®), to stronger positioning of a drug for commercialization.
Make evidence-based decisions
Rising costs, evolving standards of care, and decreased participant recruitment and retention all mean that making the right decisions earlier is more important than ever. Medidata AI provides powerful modeling along with deep regulatory, clinical, and commercial expertise to help you make evidence-based decisions with more confidence.
Key Features
Regulatory-grade Clinical Trial Data
Medidata AI Synthetic Control Arm and Trial Design provides truly “regulatory grade” data, containing traditional clinical trials style endpoints and complete covariate information, as they were designed in the clinical protocol, and subsequently captured, monitored and validated in the Medidata Rave electronic data capture (EDC) platform. The repository enables data-driven decision making by providing patient-level data in the common domains and over 100 harmonized variables.
Best-in-class Expertise
Our highly-qualified Synthetic Control Arm team includes former members of FDA, Pharma, and the research community with regulatory, biostatistics, data science and medical oncology expertise.
We work in collaboration alongside sponsors to design better trials, interact with regulators and accelerate development.
Synthetic Control Arm
Medidata AI Synthetic Control Arm has been a pioneer in defining adequate external controls and creating fit-for-purpose external controls for regulatory conversations and internal decision-making. Cohorts are built using patients drawn from previous clinical trials and selected by extracting patient-level data from the same indication, who met key eligibility criteria and were assigned to receive the standard of care. Statistical methods are then applied in a dynamic matching process that uses the baseline demographics and disease characteristics for each patient in the experimental trial to generate a historical patient group that closely matches the experimentally treated patients.
Resources
White Paper: MIT Technology Review
Download this white paper, in partnership with MIT Technology Review, to learn how Celsion leverages Medidata’s detailed information from 23,000+ trials and 7 million patients to create “external control arms” and speed up the clinical trial process.
White Paper: Go/No Go Product Development Decisions by Reusing Patient Trial Data
Learn how synthetic controls enable new insights for oncology clinical development and mitigates go/no-go decision risk.
Related Solutions
Synthetic Control Arm®
SCA® offers the only external control group created with cross-industry historical trial data.
Careful selection of patient level data yields a baseline composition that is statistically well balanced with the experimental arm to create an accurate synthetic control group.
Trial Design
Generate evidence and identify relevant data points from historical clinical trials that can serve as “ground truth” for regulatory submissions or for designing your clinical development programs. Run scenarios to identify the right data points to optimize your clinical trial design. Reduce uncertainty, reduce timelines, get to go/no-go decisions faster.
Medidata Link
Future-proof your clinical trial and enhance your evidence generation activities with Medidata Link, which allows sponsors to collect clinical trial data and link it at the patient level to real world data (RWD). Built with patients in mind, Medidata Link bridges evidence gaps to save time and help sponsors feel more confident in their decision-making.
Get in Touch
Interested in learning more?