Tool profile
Medidata: cost, fit and limits
Medidata is a clinical trial technology company, Medidata Solutions, Inc. of New York, that sells study, patient and data products including CTMS, eTMF, Rave EDC, eCOA and an AI companion called Dot. The company, part of Dassault Systemes, serves large sponsors and CROs.
What to know first
Medidata sells breadth: study design and financial tools, patient modules, and data products such as Rave, Coder+ and Safety Gateway. The home page cites more than 42,000 trials and 13 million patients engaged, which are vendor figures. The CTMS is described as AI-enabled without feature detail, and its trust page publishes an AI validation framework. Pricing runs through sales, and hosting regions are not listed apart from HDS in France.
Medidata at a glance
| Maker | Medidata Solutions, Inc., United States |
|---|---|
| Free plan | No |
| Entry price | Quote only |
| API access | Yes |
| Category | Best AI Clinical Trial Software in 2026, rank 10 of 11 |
| Website | medidata.com |
Who Medidata is best for
Global sponsors
One vendor covers CTMS, eTMF, EDC, eCOA, randomization and safety transfer, which reduces the number of contracts for a large program.
Teams already on Rave EDC
The CTMS is tightly integrated with Rave, which auto-populates dashboards and forecasts from EDC data. Both products come from one vendor, so dashboards need no custom connector.
CROs managing sponsor studies
The CTMS supports both sponsor-led and CRO-managed trials with a monitoring workspace where CRAs raise issues in context. Issues raised in the workspace stay linked to the visit record.
Medidata plans and pricing
| Plan | Price | What it includes |
|---|---|---|
| CTMS | Contact sales | Visit monitoring, issue management, oversight, document tracking, ICF review and study management, with Rave EDC and eTMF integration. |
| Study Experience modules | Contact sales | Clinical Trial Financial Management, Study Feasibility, Site Payments, Grants Manager and Protocol Optimization. Each tool is sold through the same sales process. |
| Data Experience modules | Contact sales | Rave, Rave Lite, Coder+, Companion, Safety Gateway, Clinical Data Studio and RTSM, sold by study. |
| Professional services | Contact sales | Customer success, strategy and transformation consulting, and study configuration services. Priced by scope after a sales conversation. |
Checked November 2026.
What Medidata does
- AI companion Dot
- The home page describes Dot as an AI companion and trial orchestrator. It does not detail what Dot can do, so request a walkthrough with your own study data.
- Coder+ and Safety Gateway
- Coder+ automates medical coding and Safety Gateway automates the transmission of safety cases, two tasks that carry deadlines and review duties. Both live in the Data Experience group on the home page.
- Site monitoring workspace
- CRAs get a configurable workspace with data feeds in context, and issues can be created from anywhere within it, so monitoring findings stay with the record.
- Visual Analytics
- Data from studies is combined into shared dashboards and reports, with cross-study views for portfolio managers. The home page shows them as an analysis layer across studies for portfolio managers.
- AI validation framework
- The trust page says AI requires review before deployment and continuous monitoring afterward, with human-in-the-loop workflows and alignment to the NIST AI Risk Management Framework.
How Medidata handles your data
Medidata's trust page lists SOC 2+ Type II, ISO 27001, 27017, 27018 and 27701, an HDS certificate for French health data hosting and CSA STAR. It says there is no secondary use of data without explicit written permission, that anonymized aggregated data in the Data Collaboration Program sits in a separate environment, and that data is used for AI development only when client agreements or law allow. The data privacy framework policy names Medidata Solutions, Inc. at 350 Hudson Street, New York. Hosting regions and retention periods were not stated, and the page does not explicitly say that models are not trained on customer data.
Where Medidata falls short in practice
- Sales-led contract. The CTMS page directs buyers to contact sales and states no price, so small studies cannot compare cost before a long conversation. Smaller studies lose time before any price is known.
- AI detail is thin. The CTMS page calls the product AI-enabled without naming functions, and the Dot description is brief. Ask for documented examples of each AI use. Ask for a dated product description.
- Training on customer data not explicit. The trust page limits secondary use but does not state that models are not trained on customer data, so ask for that sentence in the contract.
Works with
Alternatives to Medidata
Medidata: common questions
What does Medidata's CTMS integrate with?
The CTMS page says it is tightly integrated with Rave EDC, which auto-populates dashboards and forecasts, and with Medidata eTMF, where uploaded documents update the filing and monitoring reports are filed to the trial master file automatically. The page says dashboards and forecasts fill automatically from EDC data.
Which AI products does Medidata name?
The home page names Dot, an AI companion and trial orchestrator, an AI for Impact initiative, Coder+ for automated medical coding, Companion for eSource and EHR-to-EDC, and Safety Gateway for safety case transmission. Detail on each is limited. The home page also mentions Medidata Acorn AI in a customer video on synthetic control arms.
How does Medidata govern AI?
The trust page describes an AI Validation Framework with review before deployment and monitoring afterward, human-in-the-loop workflows, cross-functional oversight, and responsible AI principles grounded in the NIST AI Risk Management Framework and aligned with ICH-GCP. The page says detailed AI and ML documentation is maintained and available.
Does Medidata use my data for secondary purposes?
The trust page says Medidata does not engage in any secondary use of data without your explicit written permission, apart from anonymized aggregated data in a separate environment for Data Collaboration Program participants. AI development use follows written agreements or law.
How large is Medidata?
The home page claims more than 42,000 clinical trials, more than 13 million patients engaged and about 70 billion data points annually, and the CTMS page cites 530+ customers and 14K+ studies. These are vendor figures with no stated time frame.