Clinical trials that yield high-quality data serve as the connection between innovation and beneficial human outcomes. At RQM+, the MedTech CRO, they leverage the extensive operational and therapeutic knowledge to offer comprehensive clinical trial services specifically designed to meet the distinct requirements of the MedTech sector.
With proficiency across various trial types – such as early feasibility, pilot, pivotal, and post-market studies – and an emphasis on compliance, safety, and operational effectiveness, RQM+ ensures the path to dependable results, significant outcomes, and well-informed decisions regarding subsequent actions.
Clinical trial services built for success
RQM+ offers comprehensive clinical trial management solutions aimed at providing high-quality data to enhance the MedTech journey.
Through optimized operations, extensive therapeutic knowledge, and actionable insights, RQM+ guarantees compliance, efficiency, and patient safety at every stage of the process.
The services include:
Custom trial design
Customized EFS for pilot, critical, and post-approval studies developed by top specialists.
Global expertise
Effortless adherence to regulatory standards set by the US, EU, and international authorities.
Functional support
Project oversight, site viability assessment, strategic planning and implementation, data administration, medical operations and product safety, clinical site oversight, CEC/DMC adjudication management and reporting, biostatistics, and medical documentation.
Therapeutic focus areas
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RQM+ possesses extensive knowledge in various therapeutic domains, with particular emphasis on Medical Devices and In Vitro Diagnostics (IVD):
Medical device:
- Cardiology
- Orthopedics
- Neurology
- Oncology
- Ophthalmology
- Dermatology
- Endocrinology
- Gastroenterology
- Respiratory Care
IVD:
- Infectious Disease
- Oncology and Companion
- Chronic Disease and Metabolic Disorders
- Hematology and Immunology
- Neurology and Neurodegenerative Disorders
- Women’s and Reproductive Health
- Genetic and Molecular
- Gastrointestinal
Why choose RQM+?
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Why partner with RQM+ for the clinical trial consulting and management needs? Let’s count the ways:
Innovative digital tools
Sophisticated site selection and forecasting data models aimed at enhancing recruitment and trial success.
Patient-centric trial models
Real-time insights into recruitment, along with decentralized and hybrid models, as well as adaptive study designs, are essential for prioritizing recruitment and accelerating enrollment, all while ensuring patient safety and outcomes.
Proven regulatory partnerships
Robust and continuous relationships with the FDA, MHRA, and European notified bodies to adeptly navigate intricate regulations.
Flexible operating models
Tailored service line packages designed for MedTech companies of various sizes to meet their unique resource and delivery requirements.
Advanced data integration
Instruments designed to enhance multiregional trials through efficient data sharing and analytics for sponsors, along with real-time performance monitoring.
Expertise across diverse industry segments
- Medical Devices
- In Vitro Diagnostics
- Combination Products
- Software-Enabled Products
Clinical trial success stories
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- Clinical trials have been effectively overseen in more than 20 therapeutic fields, encompassing areas such as oncology, cardiovascular health, urology, and neurology
- Efficient trial designs and regulatory approaches have led to the prompt authorization of 510(k) and PMA submissions
- Reliable data and practical understandings were provided, influencing regulatory filings and market entry plans
Flexible partnering solutions
Outsourcing
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This service offers customizable and scalable solutions tailored for complete projects, specific functions, or defined segments of a function. Users can utilize RQM+'s expertise and adaptability, enabling their teams to concentrate on essential skills, company objectives, and advancements.
Consulting
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This service provides focused expertise with specific outcomes to address particular MedTech challenges. RQM+ consultants offer useful, implementable advice and direct execution to facilitate prompt solutions.
Staff augmentation
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This service addresses skill or capacity deficiencies with MedTech professionals from RQM+. It delivers professionals on demand, functional service assistance, rapid implementation for strict deadlines, and contract-to-hire choices that integrate smoothly with the user's team.
Make MedTech happen
Clinical trials are complex, but they do not have to be overwhelming
High-quality data is required to improve the product in a way that is secure and efficient. RQM+ delivers. Simple as that. With RQM+ as a partner, users will get the experienced help needed to convert obstacles into opportunities. Together, everyone can make MedTech happen quicker, safer, and better.