Medidata

What Medidata does

Medidata is a clinical trial technology company that delivers unified SaaS solutions for clinical development, operating as a wholly-owned brand of Dassault Systèmes (Euronext Paris: FR0014003TT8). Founded in 1999/2000 and acquired by Dassault Systèmes in 2013, Medidata serves approximately 2,300 customers globally across large biopharma, emerging and mid-sized biotech, MedTech, contract research organizations (CROs), and academic medical centers. Its platform has supported more than 38,000 clinical trials in 140+ countries, involving 12M+ patients, and the company reports involvement in ~80% of FDA novel drug approvals in 2025, ~70% of new molecular entities, and 50%+ of medical device trials. Academic medical centers reportedly account for more than half of Medidata's user base.

The Medidata Platform is a cloud-based, unified system organized around three Experience pillars: Study Experience, Patient Experience, and Data Experience. Core products include Rave (EDC), RTSM (randomization and trial supply management), CTMS, eTMF, Clinical Data Studio, eCOA, Medidata Consent, Medidata Imaging, Decentralized Clinical Trials, Site Payments, and a Synthetic Control Arm. Embedded within the stack is Medidata AI, with the Dot companion orchestrating AI workflows across the trial lifecycle, AI Study Build configuring EDC/eCOA from protocols, Medidata Protocol Optimization benchmarking planned protocols against historical trial performance, and Medidata Imaging providing AI-driven PHI redaction (32% faster) and anatomy verification (>97% accuracy). AI capabilities have scaled across 500+ clinical studies, including 120+ AI-supported studies initiated in 2025. The platform holds HIPAA, GDPR, and ISO 27001 certifications.

Medidata generates revenue predominantly through enterprise SaaS subscriptions, augmented by professional services for implementation and optimization. Dassault Systèmes reports >80% recurring revenue from subscription contracts with Medidata described as a significant contributor. The company is transitioning from seat-based licensing to value-based pricing, operating under quote-based enterprise contracts with pricing customized by organization size, trial volume, and module selection. Distribution combines direct enterprise field sales (large pharma, biotech, MedTech, academic centers), a certified CRO Partner Program (Worldwide Clinical Trials, R&G PharmaStudies, Tigermed, ICON, Everest, PROMETRIKA, Bioforum), and integration partnerships with technology providers (CRIO, IXICO, Cogstate, Anthropic). Medidata employs 1,001-5,000 people globally with operations across North America, Europe, and Asia Pacific (China, Japan, Korea).

Name

Medidata

Legal name

Medidata Solutions, Inc.

Website

https://medidata.com

Company type

Private

Founded year

2000

Operating status

Operating

Headcount range

1,001–5,000 employees

Short description

Medidata provides unified SaaS clinical trial solutions to roughly 2,300 biopharma, biotech, MedTech, CRO, and academic medical center customers via AI-powered study, patient, and data workflows. Its platform supports 38,000+ trials and 12M+ patients and operates as a wholly-owned brand of Dassault Systèmes.

Ownership category

akta.pro rank

Product category

Clinical Trial Management Software

NAICS

Software Publishers (5132), Software Publishers (513210)

SIC

Services-Prepackaged Software (7372), Services-Health Services (8000)

akta.pro primary industry

Clinical Trial Informatics (EDC/CTMS/eCOA/eTMF) (HLAGAJAM)

akta.pro secondary industries

AI/ML Platforms for Drug Discovery & Experiment Optimization (HLAGAJAO), Electronic Data Capture (EDC) Platforms (HLACAOAA), Scientific Data Management & Data Platforms (SDMS/Data Lakehouse for R&D) (HLAGAJAC)

Keywords

• Clinical trial software
• Electronic data capture
• Decentralized clinical trials
• Clinical trial management system
• EClinical platform

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Marketing or Sales, Infrastructure, Operations

Revenue model

1. Software Subscriptions (SaaS): Medidata generates the majority of revenue from cloud-based software subscriptions. Dassault Systèmes reports over 80% recurring revenue from subscription contracts, with Medidata representing a significant portion of this recurring revenue base. The platform is transitioning from seat-based licensing to value-based pricing.
2. Professional Services: Implementation, consulting, and managed services for platform deployment and optimization.

Go-to-market motion2 records

Distribution channels4 records

Marketing channels13 records

Core offering

Medidata sells a unified cloud-based SaaS platform for clinical trial design, execution, and data management, encompassing electronic data capture (Rave EDC), randomization and trial supply management (RTSM), electronic clinical outcome assessments (eCOA), clinical trial management (CTMS), electronic trial master file (eTMF), medical imaging, decentralized clinical trial capabilities, synthetic control arms, and integrated patient engagement tools. The platform serves pharmaceutical sponsors, biotech firms, contract research organizations, medical device companies, and academic medical centers across the full clinical development lifecycle, with embedded AI through its Medidata AI platform and the Dot AI companion.

Product overview

Medidata is a unified life science platform providing end-to-end clinical trial solutions through three interconnected Experience pillars: Study Experience, Patient Experience, and Data Experience. Built on the Medidata Platform, the offering integrates AI capabilities throughout via the Medidata AI platform and its flagship AI companion Dot. The portfolio includes core products like Rave (EDC), RTSM, and CTMS alongside specialized modules for imaging, eCOA, consent, decentralized trials, synthetic control arms, and data analytics. The ecosystem draws from over 38,000 clinical trials and 12 million patients, supporting approximately 80% of FDA novel drug approvals in 2025.

Differentiator

Problem solved

Functional benefit

Products and services

• Medidata Platform The unified cloud-based platform connecting Study, Patient, and Data Experiences with AI capabilities embedded across the clinical trial lifecycle, serving pharmaceutical, biotech, CRO, MedTech, and academic customers worldwide.
• Study Experience AI-native product suite for study design, planning, build, execution, finance, and closeout within a single connected environment for clinical trial sponsors and CROs.
• Patient Experience Digital solutions connecting end-to-end patient experience through recruitment, in-trial activities, and post-study completion on a unified platform, including eCOA, consent, sensors, and patient payments.
• Data Experience Solutions connecting every part of the clinical data process from study build to regulatory submission with built-in AI and automation, including Rave EDC, RTSM, Imaging, and Clinical Data Studio.
• Medidata Rave EDC Industry-leading electronic data capture (EDC) system for clinical trial data collection and management, used by sponsors and CROs worldwide.
• Rave Lite Electronic data capture solution designed for Phase I, Phase IV, and MedTech clinical trials with simplified configuration for smaller or earlier-phase studies.
• Medidata RTSM Randomization and trial supply management solution for managing patient randomization and drug supply logistics in clinical trials.
• Clinical Data Studio Clinical data integration and visualization solution connecting data from Medidata and external sources into a single review and monitoring environment with AI-powered data surveillance and quality monitoring.
• Medidata CTMS Clinical trial management system providing centralized operational oversight across the trial lifecycle.
• Medidata eTMF Electronic trial master file system for centralized document governance from first milestone through regulatory submission.
• Medidata Grants Manager Grant management software bringing the investigator grant lifecycle into one workflow with AI-driven FMV benchmarking, dynamic forecasting, and financial scenario planning.
• Medidata Site Payments Global clinical trial payment solution that automatically triggers payment calculations from EDC data, covering nearly every country and currency with built-in tax and invoicing.
• Synthetic Control Arm External control arm solution using validated patient-level data from prior clinical trials to create scientifically rigorous comparators when randomization is not feasible, supporting regulatory submissions.
• Medidata Protocol Optimization AI-driven protocol and feasibility intelligence for evaluating planned protocols against historical trial performance to identify and mitigate risks proactively in study design.
• Medidata AI AI platform powering the unified Medidata ecosystem, coordinating domain-specific AI companions including Dot, and enabling predictive analytics across the clinical trial lifecycle.
• Dot AI Companion Medidata's flagship AI companion serving as an intelligent core that unifies clinical workflows and coordinates domain-specific AI companions across the Medidata Platform.
• AI Study Build Generative AI capability that configures EDC and eCOA systems from study protocols, significantly reducing time from protocol to trial startup.
• Medidata eCOA Electronic clinical outcome assessments solution for capturing patient-reported outcomes in clinical trials.
• Medidata Consent Electronic informed consent technology with AI-driven study setup and user-friendly patient interface for clinical trial enrollment.
• Decentralized Clinical Trials (DCT) Flexible, hybrid trial solutions enabling remote patient participation capabilities and reducing patient burden.
• myMedidata Patient portal providing access to clinical trial participation, enrollment, and ongoing engagement for patients in trials.
• Medidata Sensors / Wearable Sensors Digital measures solution for capturing patient data through wearable sensors in clinical trials.
• Health Record Connect Healthcare data interoperability solution connecting EHR data with clinical trial systems for automated patient data transfer from electronic health records.
• Medidata Imaging Medical imaging management for clinical trials with AI-powered capabilities for automated PHI redaction, anatomy verification, and patient similarity quality control.
• Coder+ Automated medical coding solution for efficient coding of adverse events and medical terms in clinical trials.
• Safety Gateway Automated safety case transmission solution for efficient pharmacovigilance workflows.
• Targeted SDV Risk-based source data verification solution for focused monitoring based on risk assessment in clinical trials.
• Medidata Link Trial data linkage solution connecting trial data to external real-world data sources at the patient level.
• Designer Central study build hub for streamlined protocol configuration and trial setup.
• Rave Companion (eSource/EHR-to-EDC) eSource/EHR-to-EDC solution enabling direct data transfer from electronic health records into clinical trial systems.
• Adjudicate Endpoint adjudication solution for centralized review and assessment of clinical trial endpoints.
• Medidata Diversity Program Trial diversity solutions helping sponsors improve representation and inclusion in clinical trials.
• Medidata Plus AI layer providing full AI capabilities for sponsors and CROs across the Medidata Platform, including access to Dot, AI Study Build, and AI-powered workflows.
• Medidata Professional Services Implementation, consulting, and managed services supporting deployment and optimization of the Medidata Platform, including Customer Success, Strategy and Transformation Consulting, and Study Configuration Services.

Quantifiable outcome

• 72.9% of AI early adopters with over 18 months of experience report reduction in clinical trial timelines
• +11 more outcomes

Named customers18 records

Segments6 records

Ideal customer profiles5 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration3 records

AI capability10 records

Feature11 records

Partnerships

13 partnerships are on record, tiered core and strategic.

• Medidata Academic Site Advisory BoardcoreStrategic or Co-development Partner · 22 June 2026Medidata launched an Academic Site Advisory Board at the AACI-CRI annual meeting, creating a direct collaborative channel with academic medical centers including Mount Sinai Health System, Northwell Health, Mayo Clinic, and others. The board addresses unique operational and technical challenges faced by academic medical centers as they drive critical clinical research forward. Academic medical centers represent more than half of Medidata's user base and conduct 60-70% of all clinical trials worldwide.
• R&G PharmaStudiescoreChannel Partner/ Reseller/ Distributor · 1 June 2026R&G PharmaStudies, a leading CRO in China, expanded its decade-long partnership (established 2015) with Medidata to deploy the full Medidata Data Experience including Rave, RTSM, and Data Surveillance. The partnership empowers R&G to enhance trial data quality and compliance, enabling sponsors to accelerate global market launch of innovative therapies. R&G completed Medidata's Targeted Source Data Verification accreditation in 2025.
• Worldwide Clinical TrialscoreStrategic or Co-development Partner · 23 April 2026Worldwide Clinical Trials and Medidata announced an expansion of their strategic partnership, making Worldwide the first global CRO to implement Medidata Plus and gain full AI layer access across the Medidata Platform. The partnership integrates Medidata's AI capabilities, including its virtual companion Dot, into Worldwide's operations to streamline clinical trial workflows from protocol design through study close-out. The collaboration positions Worldwide ahead of traditional market standards and establishes a new model for how clinical trials are executed.
• IXICOstrategicTechnology or Integration · 28 March 2026IXICO and Medidata entered a strategic collaboration to combine neuroimaging analytics with Medidata's clinical trial platform, creating a unified neuroimaging data and analysis system for biopharma companies conducting clinical trials in neurological disorders. The combined offering is designed to streamline patient eligibility and safety reporting while enabling collection, upload, management, and analysis of complex neuroimaging data within a regulatory-compliant environment. The partnership aligns with IXICO's TechBio growth strategy.
• The Menarini GroupcoreStrategic or Co-development Partner · 9 March 2026Medidata expanded its 14-year partnership with The Menarini Group, deploying its AI Study Build technology to power Stemline Therapeutics' oncology portfolio. The technology leverages data from more than 38,000 clinical trials to automate study configurations, reducing the time between protocol finalization and trial startup from months to weeks. The partnership enables Stemline to build and launch oncology studies independently at an accelerated pace to meet urgent patient needs.
• CRIOcoreTechnology or Integration · 5 March 2026Medidata partnered with CRIO to integrate CRIO's eSource platform with the Medidata Platform, connecting over 2,500 research sites across approximately 30 countries. The integration delivers near 100% data accuracy and 90% faster data entry by automating the transfer of clinical data from research sites directly into electronic data capture systems. One in four US research sites engaged in chronic condition trials now leverages the CRIO-Medidata ecosystem.
• AnthropicstrategicTechnology or Integration · 11 January 2026Anthropic integrated Medidata into its Claude for Life Sciences suite, enabling automated clinical trial protocol drafting, enrollment tracking, and regulatory submissions. Medidata connectors were added alongside ClinicalTrials.gov and Open Targets to support clinical trial management workflows.
• National Cancer Institute (NCI)coreStrategic or Co-development Partner · 21 November 2025The National Cancer Institute expanded its partnership with Medidata to use Medidata's Data Experience solutions including Health Record Connect and Rave Companion. These solutions aim to accelerate the development of medicines by automating patient data transfer from electronic health records, reducing administrative burdens and improving data quality for NCI Lead Protocol Organizations.
• CogstatestrategicTechnology or Integration · 30 October 2025Medidata partnered with Cogstate to integrate validated digital cognitive assessments, rater training, and monitoring solutions into a unified eCOA platform. The partnership includes a strategic partnership announced in October 2024 to integrate AI-powered cognitive assessments into neurology clinical trials. The collaboration combines Cogstate's validated digital cognitive assessments with Medidata's eCOA platform.
• SanoficoreStrategic or Co-development Partner · 23 October 2025Medidata extended its collaboration with Sanofi to improve clinical research and patient care through AI-embedded platform solutions. The expanded partnership aims to streamline processes, reduce costs, and accelerate the development of new therapies globally. Sanofi is leveraging Medidata's decentralized clinical trial expertise and platform solutions to enhance study design, data quality, and patient care.
• TigermedstrategicChannel Partner/ Reseller/ Distributor · 1 January 2025Medidata extended its partnership with clinical research provider Tigermed in January 2025, expanding collaboration in the clinical research outsourcing market.
• BioforumstrategicStrategic or Co-development Partner · 13 November 2024Medidata and Bioforum expanded their decade-long relationship to advance clinical data and biometric solutions for clinical trials. The collaboration aims to improve operational efficiency and data management for clinical studies, with Bioforum integrating additional Medidata platforms to enhance access to AI-powered clinical trial solutions.
• Medidata Research AlliancestrategicStrategic or Co-development Partner · 1 January 2023The Medidata Research Alliance is a consortium bringing together leading clinician researchers and key opinion leaders from academia, nonprofit organizations, and the life sciences industry to leverage Medidata's expertise in AI and clinical trial data to drive cutting-edge research into innovative treatments. The Alliance has produced research on CAR-T therapies and oncology protocol optimization presented at ASCO 2026.

Scale indicators14 records

Recent moves6 records

Expansion highlights7 records

Broad incumbents

• Parexel International: Major global CRO with significant technology and decentralized trial capabilities. Competes with Medidata both as a buyer of clinical technology and as a provider of integrated trial services to sponsors.
• IQVIA: Largest CRO with proprietary technology including the Digital Trial Solutions suite and Orchestrated Patient Engagement. Competes with Medidata as both a customer (CRO partner) and as a bundled clinical technology provider to sponsors.
• Oracle Health Sciences: Operates Oracle Clinical, EDC, and broader life-sciences analytics within Oracle's enterprise software portfolio. Overlaps with Medidata in EDC/CTMS and increasingly in real-world evidence for large biopharma.

Emerging players

• Castor: Cloud-native EDC and ePRO provider serving academic medical centers, CROs, and emerging biotech. Focuses on modern UX, faster study build, and lower-cost deployments, increasingly overlapping with Medidata Rave in mid-market segments.
• Florence Healthcare: Site-focused eRegulatory and eSource platform integrated into thousands of research sites. Overlaps with Medidata's site-facing offerings (Site Insights, Rave Companion) and is part of the broader site enablement ecosystem.
• Medrio: Cloud-based EDC, ePRO, and eConsent platform serving Phase I–IV and medical device trials. Competes with Rave in mid-market and Phase I/IV segments where Medidata positions Rave Lite.

Direct peers

• Veeva Systems: Closest direct competitor to Medidata, offering Vault CTMS, Vault EDC, eTMF, and a life-sciences CRM suite. Veeva targets the same large biopharma and emerging biotech customers with a similarly enterprise SaaS GTM motion.
• Anju Software: Mid-sized clinical trial and life-sciences software provider covering EDC, CTMS, eTMF, and pharmacovigilance. Sells into similar biopharma and CRO customers and competes on platform breadth against Medidata.
• ArisGlobal: Life-sciences R&D platform offering unified safety, regulatory, clinical, and medical affairs solutions. Targets the same large and mid-sized biopharma buyer with a cloud platform comparable in scope to Medidata's Experience pillars.

Others

• ICON plc: Global CRO that both consumes and influences clinical-trial technology choices. Listed as a customer using Clinical Data Studio, but also offers proprietary technology and partner platforms, making ICON an ecosystem participant more than a direct technology peer.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat7 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/Medidata
• YouTubeyoutube.com/user/MedidataSolutions
• LinkedInlinkedin.com/company/medidata-solutions
• Instagraminstagram.com/medidata.solutions
• Facebookfacebook.com/MedidataSolutions

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles6 records

Funding overview

Funding rounds4 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A7 records

Investments5 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Medidata