Safety And Reliability
Medical Devices
In the Medical Devices sector, accuracy, efficiency, and strict compliance with regulations are crucial to ensure the safety and effectiveness of medical devices. ResearchManager provides a comprehensive set of tools and solutions to support Medical Device Studies in all aspects of clinical research and product development, with a focus on compliance. This includes pivotal, pilot, and post-market surveillance (PMS) studies.
Integrated clinical processes and document management with CTMS and eTMF
The proper integration of clinical processes and document management is essential for the success of Medical Device Studies. ResearchManager provides an integrated solution with a Clinical Trial Management System (CTMS) for managing clinical processes and an Electronic Trial Master File (eTMF) for efficient document management. With these tools, part of the Clinical Research Suite, organizations can focus on key aspects of the research process, such as (local) feasibility, site selection and contracts, regulatory compliance, visit tracking, finances, monitoring, and project management. Without having to worry about compliance with laws and regulations, as it is ensured in our platform where compliance takes precedence.
Reliable data collection with EDC (Electronic Data Capture)
Modern and digital data collection is crucial for assessing the safety and effectiveness of Medical Devices. ResearchManager EDC (Electronic Data Capture) provides reliable tools and features to collect and manage data at the highest level of security in real-time. Additionally, we can integrate other tools, such as Randomization and Trial Supply Management (RTMS), Electronic Patient-Reported Outcomes (ePRO), and Electronic Informed Consent (eConsent), to further optimize data collection and enhance participant engagement.
Integration with wearables and databases using APIs
During a Medical Device Study, we can integrate and link data from wearables and external databases with the research. This allows developers and researchers to gain comprehensive insights to further optimize their clinical research. We achieve this through an API. The ability to link various sources enhances the research, provides a complete picture of the situation, and contributes to decision-making regarding the ongoing study and future steps.
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All-in-one suite for every stage of clinical research
The Clinical Research Suite (CRS) is an all-in-one solution for managing Clinical Data and Operations, from trial planning to completion. CRS provides a cost-effective solution by combining multiple tools and services into one platform, reducing the need for multiple vendors.
Scalable Solutions for Organizations of All Sizes
The Clinical Research Suite scales to meet the needs of any organization. Small organizations can choose the Pay-as-you-go On Demand model, while mid-size and large organizations benefit from the Enterprise package with structured plans for multiple ongoing studies, ensuring efficient resource management and growth.
Fast-go live within 5 working days
The Clinical Research Suite (CRS) offers a fast go-live option within 5 working days. Additionally, fully customized implementations are available, tailored to specific needs, ensuring the platform aligns perfectly with trial requirements.
Dedicated team with personalized support
Experienced in-house second-line assistance and a dedicated account manager are always included to ensure seamless operations and personalized guidance throughout the entire process.
Proven success
With over 20,000 studies conducted, 8,000+ active users, and more than 1,000,000 patients enrolled, ResearchManager’s Clinical Research Suite (CRS) has a proven track record of delivering successful clinical trials worldwide.
Commonly used tools by medical devices
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Saskia van Gastel
Accountmanager