Get your medical device one step closer to the market, trust an experienced and competent team to complete required investigation trials that verifies safety and performance of any medical product.
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 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.
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.
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:
- Project and quality management
- Research and clinical trial assistance
- Regulatory affairs management and operation
- Data analysis
- Statistical and biostatistical indication
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
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) 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.
How 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.
Here are some tips about what you should pay attention to when searching for the right CRO for your device:
- Look for companies with experience in medical devices
- Determine if the company has the necessary expertise and resources to support your project
- Ensure that the CRO has a deep understanding of regulatory requirements
verify that the company has a strong Quality Management System
Is also important to know that clear communication and transparency are essential for a successful partnership!
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.
Our team, led by former notified body leadership, will help you to collect the clinical data and gathering validation of clinical benefits by demonstrating sufficient evidence in order to achieve MDR certification, extending beyond your Clinical Evaluation Report to risk management, PMS, PMCF, and labelling.
ECLEVAR has a customizable market access approach in both global and local markets. We can help you determine what evidence you need to gather to have a successfully launch of your product.
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.
