Welcome to Medidata AI

Revolutionizing Clinical Trials with Medidata AI

Medidata AI, offered by Medidata Solutions, is a cutting-edge, AI-powered platform designed to optimize and transform various phases of clinical trials. It provides powerful tools to enhance patient enrollment, data collection, trial monitoring, and reporting. By leveraging advanced analytics and machine learning, Medidata AI enables clinical researchers to make data-driven decisions, streamline processes, and improve the overall quality of clinical trials.

How Medidata AI Supports Clinical Trials

Medidata AI supports clinical trial processes in the following key areas:

Site Selection

Uses historical data to identify optimal trial locations, reducing delays and increasing operational efficiency.

AI tools assist in matching participants with inclusion/exclusion criteria and estimating enrollment timeframes.

Medidata's Rave EDC system ensures the integrity and real-time accuracy of collected data, while centralized monitoring allows sponsors to perform remote assessments.

Analytics Tools

AI-powered tools simulate trial outcomes, generate reports for regulatory submissions, and help optimize trial designs.

Use in Clinical Trials

Medidata AI has been applied widely in several therapeutic domains and clinical studies. Its application in oncology studies, where it was used to find suitable individuals, monitor the trial’s advancement, and enhance patient safety monitoring, is a significant example. It was shown to be beneficial in a breast cancer study where sponsors were able to swiftly transition from recruiting to trial execution by over 30% in patient enrollment time. Additionally, Medidata’s AI played a critical role in optimizing data gathering and analysis, leading to a notable increase in data accuracy and a reduction in reporting deadlines.

Statistics of its benefits on clinical trials

clinical trials and 9 million participants have benefited from Medidata's platform.
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FDA-approved drugs were developed using Medidata’s technology.
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rare disease studies are supported by Medidata AI involving 320,000 participants.
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of patients reported feeling comfortable using wearable technology for trials.
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annual growth rate of the clinical trial technology market.
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of organizations used Medidata's ePRO and eCOA tools for electronic data collection.
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How it Works?

Medidata’s predictive coding machine learning (ML) algorithm is built upon over 60 million historical coding decisions by expert medical coders. These include more than 30 million decisions for MedDRA (Medical Dictionary for Regulatory Activities) and over 30 million for WHODrug, spanning multiple dictionary versions. This vast dataset comes from thousands of studies and helps ensure accurate coding of drug, symptom, and procedure terms in clinical trials.

Medidata AI integrates advanced AI algorithms and machine learning to improve clinical trials in several ways. It analyzes historical data to optimize site selection, streamlines patient enrollment through its eConsent platform, automates data collection, and ensures continuous monitoring of trial progress. Through its centralized platform, sponsors can conduct remote monitoring and risk-based assessments, all while adhering to Good Clinical Practice (GCP) guidelines and Health Canada regulations.

Compliance with GCP and Health Canada Regulations

Medidata AI complies with several regulatory standards across different clinical trial phases:

Participant Enrollment

The platform’s eConsent solution adheres to ICH GCP E6(R3) and Health Canada guidelines for informed consent, providing secure, electronic signatures and participant consent management.

Data Collection & Management

The Medidata Rave EDC platform ensures compliance with data integrity standards outlined by ICH GCP E6(R3). It allows for real-time data monitoring and validation of clinical data systems.

Monitoring and Reporting

The platform supports risk-based monitoring practices, allowing for remote monitoring in compliance with GCP guidelines and Health Canada's acceptance of remote procedures.

Head Office

350 Hudson Street, 9th Floor, New York, NY 10014

Customer Support

+1 919-933-2200

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