Affordable Clinical Trials Management for Medical Device Development
Designed to reduce costs for companies developing new medical device, a Contract Research Organisation (CRO) makes biologic assay, commercialization development and clinical trials management affordable to the Medtech industry. A CRO can help you fulfil your clinical and regulatory demands with expertise and outsourced support.
Why Partner with a CRO?
A Contract Research Organisation provides specialized research services to the biotechnology, pharmaceutical and medical device industries through contract agreements, offering different functions and specialities according to the needs and requirements of a specific product.
By outsourcing critical clinical and regulatory tasks, medical device manufacturers gain access to expert teams, reduce operational costs, and accelerate time-to-market while maintaining the highest standards of quality and compliance.
Why Contact a Contract Research Organisation
A Contract Research Organisation is a company dedicated to providing research services to the biotechnology, pharmaceutical and medical device industries through a contract agreement, offering different functions and specialities, according to the needs and requirements of a specific product.
How CRO Partnerships Work
It works this way: a sponsor (medical device/product manufacturer) hires a CRO company to take care of specialized tasks for a trial, that can be whether a full service, staffing clinical or regulatory, depending on the sponsor's needs.
Data Integrity & Responsibility
The data collected by the trials and studies must be unbiased and present the entirety of the regulatory demands. The sponsor is the one who holds the responsibility for the quality and integrity of the medical product, the CRO only being accountable for the well-performing of the tests and evaluation.
The Main Roles of a Contract Research Organisation Partnership
A high standard team is ready operate at every step of a clinical trial and pre-market strategies. Here are the main roles of a CRO company:
Protocol Development
Design and development of comprehensive clinical trial protocols that meet regulatory requirements and scientific objectives for medical device evaluation.
Site Selection & Management
Identification, qualification, and ongoing management of clinical trial sites to ensure optimal patient recruitment and data quality.
Regulatory Affairs
Expert guidance on regulatory strategy, submission preparation, and ongoing communication with regulatory authorities throughout the approval process.
Data Management
Comprehensive data collection, validation, and management systems ensuring data integrity, security, and regulatory compliance.
Clinical Monitoring
On-site and remote monitoring to ensure protocol compliance, data accuracy, and patient safety throughout the clinical trial.
Medical Writing
Professional preparation of clinical study reports, regulatory submissions, and clinical evaluation documentation required for market approval.
Cost-Effectiveness & Expertise
Besides the advantage of having a highly qualified team working on your project, hiring a Contract Research Organisation makes the process less expensive than doing it inside your own company. That's why those organizations work with different types of institutions that benefit them with flexible resources and significant cost decrease that are passed on to the clients.
Clinical Evaluation Report and Post-Market Clinical Follow-Up
Clinical Evaluation Report (CER)
A Clinical Evaluation Report (CER) is a document that exposes a clinical assessment's conclusions of a medical device. The report must provide evidence, that conveys safety and regulatory compliance for the manufactured product in question by structuring an analysis of pre-market and post-market clinical data.
Post-Market Clinical Follow-up (PMCF)
Post-Market Clinical Follow-up (PMCF) is a crucial procedure. The medical product manufacturer must actively present the clinical data available so it can be possible to assess the benefit/risk ratio. Throughout the entire life cycle of the medical device, the updating of clinical data through the implementation of a post-marketing follow-up study has become a standard requirement.
Comprehensive Clinical Evidence Support
CER and PMCF are essential components of medical device regulatory compliance under EU MDR. A qualified CRO ensures that your clinical evaluation documentation meets all regulatory requirements and provides robust evidence of safety and performance throughout your device's lifecycle.
Ready to Accelerate Your Medical Device Development?
Contact our CRO experts to discuss how we can support your clinical trial and regulatory needs.
Get in TouchHow to Choose a CRO Company
Choosing the right Contract Research Organization to partner up with is a most important task for putting a medical product on the market, for there are many specifications and regulatory demands that must be followed in order to get an approval for distribution.
That's why you'll have to pay attention to a number of characteristics of many companies that provide that kind of service and select the one that offers personalization and expertise.
Key Selection Criteria
Here are some tips about what you should pay attention to when searching for the right CRO for your device:
- Experience in medical device clinical trials and regulatory affairs
- Proven track record in your specific therapeutic area
- Understanding of relevant regulatory frameworks (EU MDR, FDA, MHRA)
- Quality Management System certification (ISO 13485, GCP compliance)
- Transparent pricing and clear project timelines
- Availability of specialized expertise (biostatistics, medical writing, regulatory)
- Flexibility to adapt to your project's unique requirements
- Strong references and industry reputation
- Technology capabilities and data management systems
- Geographic coverage and site network relevant to your study
Communication is Key
Is also important to know that clear communication and transparency are essential for a successful partnership!
Consider Smaller CROs
There are several reasons why a smaller CRO may be better suited for some medical device projects, you can check them here.
ECLEVAR: A Contract Research Organisation You Can Trust
ECLEVAR is an agile CRO with more than 20 years of experience in offering pre and post market studies for medical devices that offers cost effectiveness services, time savings and management of regulatory constraints. As a leading contract research organization, we provide innovative solutions to help you bring your product to market.
Expert Leadership
Our team, led by former notified body leadership, brings unparalleled regulatory insight and clinical expertise to every project.
Comprehensive Clinical Data
We help you collect clinical data and gather validation of clinical benefits by demonstrating sufficient evidence for MDR certification.
Beyond CER
Our services extend beyond Clinical Evaluation Reports to risk management, PMS, PMCF, and labelling support.
Market Access Strategy
ECLEVAR has a customizable market access approach in both global and local markets to ensure successful product launch.
Evidence Planning
We help you determine what evidence you need to gather for regulatory approval and market acceptance.
Cost-Effective Solutions
Benefit from our agile approach that delivers high-quality results while optimizing costs and timelines.
20+ Years of Medical Device Expertise
With over two decades of experience in pre-market and post-market studies, ECLEVAR combines deep regulatory knowledge with practical clinical trial execution. Our former notified body leadership ensures that every aspect of your clinical evaluation meets the highest standards of regulatory compliance.
Our Comprehensive CRO Services
Pre-Market Clinical Trials
Complete support for investigational studies required for initial market approval, from protocol development through final clinical study report.
Post-Market Clinical Follow-Up (PMCF)
Ongoing clinical evidence collection throughout your device's lifecycle to maintain regulatory compliance and support continuous improvement.
Clinical Evaluation Reports (CER)
Expert medical writing services for comprehensive clinical evaluation documentation that meets EU MDR requirements.
Regulatory Strategy & Submissions
Strategic guidance on regulatory pathways, submission preparation, and ongoing communication with regulatory authorities.
Risk Management & PMS
Integrated approach to risk management and post-market surveillance to ensure ongoing safety and performance monitoring.
Partner with ECLEVAR for Your Medical Device Clinical Research
Selecting the right Contract Research Organisation is critical to your medical device's success. ECLEVAR combines specialized expertise, regulatory insight, and cost-effective solutions to accelerate your path to market while ensuring full compliance with global regulatory requirements.
Our team of experienced professionals understands the unique challenges of medical device development. From initial clinical trial design through post-market surveillance, we provide comprehensive support tailored to your specific needs and therapeutic area.
With ECLEVAR as your CRO partner, you gain access to former notified body leadership, proven clinical trial methodologies, and a flexible approach that adapts to your project requirements. We're committed to delivering high-quality results on time and within budget.
You can learn more about Contract Research Organisation functions and ECLEVAR's work at our website and blog. Or contact us to know what we can do to help your device reach your targeted market.