Medical Device Clinical Trials

Achieve Clinical, Regulatory, and Long-term Success

Why do companies running medical device clinical trials trust Medidata?

Amidst increased regulatory complexities and growing cost pressure, medical device companies need a trusted and dedicated partner to get products to market faster, amplify top-line growth, and succeed.

With 20+ years of ongoing digital innovation and leadership, Medidata is a proven partner with technology solutions and a dedicated team of professional experts who fully understand the unique challenges and specific needs of the medical device business.

  • 811 – Medical Device Trials
  • 194 – Unique Medical Device Trial Sponsors
  • 21,300  – Medical Device Sites
  • 400,000 – Device and Diagnostic Patients
White Paper

Trailblazing the Medical Device Trials Landscape: Experts Share Insights on Industry Challenges and the Value of Choosing the Right Technology Provider

Medical device clinical trials encounter distinctive hurdles, owing to the swiftly evolving medical device landscape, intricate regulations, cost constraints, and the shift toward value-based care. To overcome these obstacles, reliable clinical evidence is crucial for gaining acceptance from regulators, payers, and patients. This white paper offers insights from interviews with medical device industry decision-makers, addressing pain points, key considerations for clinical trial solutions, and thoughts on future technology areas.

White Paper

Breaking Barriers in Medical Device Development: The Convergence of Data and Regulatory Compliance

Adapting to new regulatory requirements is crucial for companies’ commercial viability and reputation, and the ability to respond quickly and efficiently is vital. This paper focuses on the ever-changing regulatory environment in the medical devices industry.


“A consistent, unified approach to manage all our clinical trials as we expand our portfolio of advanced medical products to better the lives of patients.”

“Medidata was great. They created user requirements. They drafted documents for us, and they really guided us every step of the way.”

“What we liked about the Medidata platform was the ability for us to better manage our clinical studies with improved oversight and reporting capabilities.”

“We looked for reputation, scalability, and a complete platform approach for all stakeholders, and found that with Medidata eTMF, Rave EDC, and Payments.”
Medical Device Clinical Trials

Achieve clinical, regulatory,
and commercial success

Facing increasing regulatory complexity and scrutiny, medical device companies rely on Medidata to generate evidence, improve patient safety, and comply with requirements such as EU MDR.

One technology platform to power people, processes, and progress.

Medidata helps you adapt, simplify, scale, and accelerate your clinical trials, from protocol design to study startup, conduct, close-out, and commercialization.

Our platform is built to enable you with cloud-based, modular, integrable, easily configurable capabilities, all powered by the latest patient, clinical and operational data, and AI solutions.

The industry’s only complete Decentralized Clinical Trial solution

It’s indisputable. The decentralized clinical trial is the future for medical device companies. But not all decentralized clinical trial solutions are the same. You need a solution that’s easy to implement, easy to use, efficient, and unrivaled in its ability to strengthen your data.

Truth in data:

  • 800+ studies, 600K+ patients, 44K+ sites using a Medidata DCT solution
  • Supported one of the fastest-recruiting decentralized trials in history with 30,000+ patients and 13,000+ devices

Read more about our end-to-end decentralized clinical trials for medical device organizations.

The industry’s only platform to leverage cross-industry clinical trial data

Advanced data and analytics present an enormous opportunity to medical device companies. The challenge is finding a solution that balances cost, patient safety, and data integrity – while delivering the intelligence you need at every step in your medical device clinical trials.

Truth in data:

  • Clinical trial data from 7 million patients and 25,000+ trials
  • 45B+ data points
  • 63% growth in data volume in 4 years

Learn more about our data and analytics solutions for medical device companies.

The results-driven approach to unifying teams, data, and processes

Disconnected data sets and processes lead to trial delays and extra costs for medical device companies. The solution? Standardize on a single, easy-to-use cloud-based platform, enhancing visibility across trials, accelerating time-to-market, and ensuring data security, privacy, and compliance.

Truth in data:

  • 5 days to reach database lock
  • 80% reduction in data correction rates
  • 40% reduction in edit checks

Learn more about our unified technology platform for medical device companies.

The industry’s most comprehensive patient-centric solutions

New patient technology and processes can present unique challenges to medical device companies. We can help. Our industry-leading patient solutions ensure data security, privacy, and compliance while increasing patient recruitment and retention in your medical device clinical trials.

Truth in data:

  • Cross-industry clinical trial data from over 25,000 trials and over 7 million patients
  • Datasets pre-integrated with real world data

Learn more about our patient-centric clinical trial solutions for medical device companies.


“The overall experience for us from configuration and implementation to ‘Go Live’ of Medidata’s Remote Source Review has been positive. It’s been a true partnership and the best solution for us at a critical time of need.”

Kevin Walthers
Global Clinical Project Manager, Boston Scientific

Related Solutions

United Clinical Data Solution

United Clinical Data Solution

Rave EDC is at the heart of Medidata’s unified solution for Clinical Data Capture and Management, enabling aggregation and reconciliation of data from multiple sources – Medidata eConsent, Medidata eCOA, MyMedidata, Rave RTSM, Rave Imaging and Sensor Cloud; and intelligent data review and analysis with Rave TSDV and Medidata Detect.

Clinical Operations

Clinical Operations

Rave CTMS is a unified digital solution that improves the speed, efficiency, and collaboration for the oversight of studies, countries, and sites through automation and workflow management. Rave CTMS supports activities including study/site team creation and activation, patient enrollment and milestone tracking, site monitoring, and issue management.

Rave Imaging

Rave Imaging

Rave Imaging provides cloud-based, secure management for all your medical imaging tasks in an innovative and intuitive system. Gain visibility and full control over your imaging data while simplifying processes for sites, sponsors, and core labs alike.