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O que procurar em um CRO de Dispositivo Médico

Outsourcing clinical pesquisa to a dispositivo médico CRO can be a good decision for small medical device businesses. Here’s what to look for while hiring a medical device CRO or consultor de dispositivos médicos

Small-to-medium-sized medical device companies often don’t have the resources to be able to hire full-time teams who can handle all the complexities of clinical research for medical devices. Regulatory requirements, ethical considerations, routes to regulatory approval, technical documents: all of them form a crucial part of the clinical trial process. It is important that medical device companies choose a CRO that has had a good track record of success performing ensaios clínicos and are up-to-date with the latest regulations in different geographies. Here are 3 things to look for while outsourcing pesquisa clínica a uma CRO. 

A experiência certa 

Ao escolher um CRO para sua pesquisa, escolha um que tenha experiência específica em dispositivos médicos. A CRO já trabalhou com dispositivos médicos de diferentes classes? Eles são especializados em uma classe específica de dispositivo ou em uma área terapêutica específica? 

Shrinidh Joshi, consultor em pesquisa clínica e escritor médico freelance on Kolabtree, says, “Many CROs are pharmaceutical-focused and lack sufficient medical device trial experience. Medical device companies should identify this fact early in the CRO evaluation process. The core operational aspects of running pharma and medical device clinical trials are the same, but there are also significant differences. If a CRO has mainly dealt with the pharma clinical trials then it is more than likely that their expertise is not in medical device space.” 

He advises, “Medical device companies should be looking for more than general medical device trials experience in a CRO. The ideal vendor for medical device clinical trial will have demonstrated success in conducting clinical research in the product’s therapeutic area and for its specific indication. If the CRO has worked for product designs and devices that are similar to your device or predicates that would be an ideal CRO.” 

Transparência 

Honest communication and transparency is the key to a good working relationship. Shrinidh recommends, “While working with a CRO, I cannot stress enough on the importance of mutual transparency, trust, honesty, and communication on both sides of the sponsor (medical device company)-vendor (CRO) relationship beginning as early as the evaluation phase.

“Sponsors should be open with a CRO about exactly what they need from the agreement, what their definitions of success and failure are, what they can afford, and how long they expect the work to take. They should be honest about their in-house capabilities (or lack thereof). It’s also beneficial for sponsors to communicate their strategic approach going forward — not only in clinical but in sales and commercial. It is possible that within the medical device community, the clinical trial environment is relatively new so the sponsors are not necessarily comfortable sharing long-term strategies, commercial strategies, or managed care strategies with CROs or vendors. However, as an insider, I can say that it is so important for vendors to understand the long-term strategies of sponsors.

“On the other side, sponsors should hold out for a vendor that is candid regarding its specific capabilities, areas of strength and weakness, specific services provided, costs, etc. Proper alignment between the medical device company and CRO is important for the success of a medical device clinical trial. The advantages of building a collaborative, mutually respectful relationship with your CRO can be significant.” 

Experiência com exigências regulatórias 

Ao escolher uma CRO, é importante garantir que eles sejam especialistas nas exigências regulatórias e regras éticas que regem a pesquisa clínica. Na Europa, as empresas de dispositivos médicos precisam cumprir os Regulamentos de Dispositivos Médicos e obter a marca CE, o que lhes permite colocar um produto no mercado da UE. A avaliação clínica constitui uma parte importante do processo, e a manutenção e atualização de um relatório de avaliação clínica ou CER é obrigatório. Como o MDR ainda é novo e ainda há alguma incerteza sobre o que exatamente é exigido, é importante trabalhar com um especialista que tenha experiência em escrever CERs especialmente de acordo com a nova regulamentação. Nos EUA, o FDA rege aspectos da pesquisa clínica. Todos os ensaios clínicos são necessário para obter a aprovação da IRBque revisa o protocolo de ensaios clínicos e assegura que o estudo atenda a considerações éticas. Garanta que você trabalhe com consultores que conheçam bem os caminhos da FDA para aprovação, documentos técnicos, protocolos de ensaios clínicos e diretrizes internacionais para a realização de ensaios. Sempre peça exemplos de ensaios clínicos com dispositivos médicos nos quais eles já tenham trabalhado antes e certifique-se de que o que eles podem entregar atenda às suas expectativas. 

Quando você deve trabalhar com consultores independentes de produtos médicos 

Depending on your requirements you may want to consider working with independent consultants, rather than hiring a full-fledged CRO. Maybe you’re looking for help with a very specific aspect of your research: a one-person job. You may need help with elements of your clinical research such as:

Trabalhar com consultores de produtos médicos sob demanda torna mais fácil para você explicar suas exigências de forma individualizada e personalizar seus produtos. Você economiza em custos gerais e gastos gerenciais que podem vir com o trabalho com um CRO. Com base na complexidade de seu dispositivo médico e no tipo de suporte que você precisa, você pode escolher a melhor abordagem que o ajude a obter o máximo benefício para que você possa lançar seu dispositivo médico com confiança.  

Necessidade de consultar um especialista em dispositivos médicos? Connect with experts directly on Kolabtree. It’s free to post a project and get quotes. Comece agora


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