Medidata Rave

Electronic data capture for regulated clinical trials, sold only through a sales process

As of 31 August 2026, Medidata Rave's pricing is not published; the vendor quotes on request. The EDC system a large share of registrational trials run on, owned by Dassault Systemes since 2019. Softwr lists it under Research. Medidata Rave is made by Medidata Solutions, a Dassault Systemes company, available on Web.

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Overview

What Medidata Rave does

Medidata Rave EDC is an electronic data capture and clinical data management system used to collect, clean and report data from clinical trials. It handles case report form design, edit checks, query management, coding, and the audit trail and validation evidence that 21 CFR Part 11 and GCP inspections require. Medidata also sells a reduced version, Rave Lite, aimed at Phase I, Phase IV and device studies. The commercially decisive fact is that Rave is priced per study, not per seat, and the licence is rarely the largest number. Study build, mid study amendments, integration work and the validation documentation are where budgets go, and each protocol amendment that changes a form triggers billable rework. Sponsors that run many small studies feel this far more than sponsors that run a few large ones, which is exactly why Rave Lite exists. Buyers are pharmaceutical and biotech sponsors and the CROs that run studies for them. Because CROs have standing Rave capability and trained data managers, choosing Rave often means a wider choice of CRO and a shorter startup path. The trade-off is cost and rigidity: it is an expensive, process heavy system that assumes a professional data management function, and a small sponsor without one will find it hard to operate directly.

What people use it for

A sponsor running a registrational Phase III study where inspection readiness and a validated audit trail are non negotiable
A biotech that wants its CRO to run data management and benefits from the CRO already having Rave trained staff and templates
A sponsor standardising forms across a programme so that a global library is reused rather than each study being built from scratch
A device or Phase IV study where Rave Lite gives the same compliance posture at a lower configuration burden

Where it falls short

Concrete and checkable, so you can decide whether any of them matter to you. This is the half of a review a vendor will not write about Medidata Rave.

No pricing is published at all, so a first time sponsor cannot budget a study without entering a sales process and usually cannot benchmark the quote against anything.
Cost is dominated by study build rather than licence, and every protocol amendment that changes a form triggers billable rework, so a study with unstable protocols costs far more than the initial quote implied.
Configuration requires trained specialists, so most sponsors cannot build a study in house and are dependent on Medidata professional services or a CRO, which lengthens startup.
The system assumes a professional clinical data management function; a small sponsor without data managers will not operate it directly and will pay a CRO to do so.
Deep use of the wider Medidata platform for randomisation, imaging and patient reported data creates commercial lock in, because moving EDC later means unpicking integrations that were bought as one bundle.

Pricing

What Medidata Rave costs

Taken from the vendor's own pricing page. Prices move, so check before you buy.

Medidata Rave EDC

On request

Priced per study through a sales process
Study build and configuration charged separately from licence
Mid study amendments generally billable
Validation and qualification documentation supplied
Rave Lite available for lower complexity studies

Capabilities

Features

Case report form design
Form and edit check authoring with a reusable global library across studies
Edit checks and queries
Automated data validation with a query workflow and full audit trail
Part 11 audit trail
Attributable, time stamped record of every change for inspection
Rave Lite
A cut down configuration for Phase I, Phase IV and medical device studies
Coding and safety
Medical coding against MedDRA and WHODrug and safety data flow
Platform integrations
Connections to randomisation, imaging, eConsent and sensor data within the Medidata platform

Answered, with sources

Questions people ask

Each answer names the page it came from, so you can check it rather than take our word for it.

Who owns Medidata?

Dassault Systemes, which acquired Medidata in 2019. Rave is sold as part of the Dassault life sciences portfolio.

How is Rave priced?

Per study, through a sales process. Nothing is published, and study build and amendments are charged separately from the licence.

Is Rave validated out of the box?

Medidata supplies validation and qualification documentation, but the sponsor still owns study level user acceptance testing and its own validation evidence.

What is Rave Lite for?

Lower complexity studies, typically Phase I, Phase IV and medical device, where a full study build is not justified.

Keep looking

Where to go from Medidata Rave

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Softwr does not host reviews and shows no star rating for Medidata Rave, because a rating we did not collect is not ours to publish. What is here is the pricing and platform detail from the vendor’s own pages, limitations we could state concretely, and alternatives a reviewer confirmed people weigh against it. Tell us if any of it is wrong.

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