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.
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.
Why do companies running medical device clinical trials trust Medidata?
Amidst COVID-19 disruptions, supply chain delays, and increased regulatory complexities, 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 services and implementation experts who fully understand and serve the unique challenges and specific needs of the medical device business.
“THE ROADMAP TO SUCCESS IN MEDICAL DEVICE CLINICAL TRIALS” eBOOK
How Medidata enables medical device clinical trials
Generate Evidence with Proven Technology
Stay connected to patients, collect and integrate data from devices in-market to generate evidence for clinical trials & regulatory requirements such as EU MDR using a robust, scalable, flexible clinical development platform.
Accelerate Speed to Market
Get products to patients faster by designing and running better trials, reducing redundancies, and focusing on higher-value tasks with insights from data and advanced analytics throughout.
Lead for the Future
Always be ready to meet future challenges. Integrate solutions that will respond to evolving changes in the clinical development process, from new technologies, data sources, regulations, to the rise of decentralized trials. Lead in the marketplace by establishing a foundation for innovation and growth.
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
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
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 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.