{"id":7719,"date":"2020-06-01T13:57:17","date_gmt":"2020-06-01T13:57:17","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7719"},"modified":"2020-06-01T13:57:17","modified_gmt":"2020-06-01T13:57:17","slug":"what-to-look-for-in-a-medical-device-cro","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/what-to-look-for-in-a-medical-device-cro\/","title":{"rendered":"What to look for in a Medical Device CRO"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Table of Contents<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f237caa29a3\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f237caa29a3\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/what-to-look-for-in-a-medical-device-cro\/#The_right_expertise\" title=\"The right expertise\u00a0\">The right expertise\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/what-to-look-for-in-a-medical-device-cro\/#Transparency\" title=\"Transparency\u00a0\">Transparency\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/what-to-look-for-in-a-medical-device-cro\/#Experience_with_regulatory_requirements\" title=\"Experience with regulatory requirements\u00a0\">Experience with regulatory requirements\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/what-to-look-for-in-a-medical-device-cro\/#When_you_should_work_with_independent_medical_device_consultants\" title=\"When you should work with independent medical device consultants\u00a0\">When you should work with independent medical device consultants\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><i><span style=\"font-weight: 400;\">Outsourcing clinical <a href=\"https:\/\/www.kolabtree.com\/blog\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">research<\/a> to a medical device CRO can be a good decision for small medical device businesses. Here\u2019s what to look for while hiring a medical device CRO or <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">medical device consultant<\/a>.\u00a0<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">Small-to-medium-sized medical device companies often don\u2019t 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 clinical trials and are up-to-date with the latest regulations in different geographies. Here are 3 things to look for while outsourcing <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">clinical research<\/a> to a CRO.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_right_expertise\"><\/span><strong>The right expertise\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">While choosing a CRO for your research, pick one that has experience specific to medical devices. Has the CRO worked with medical devices of different classes? Do they specialize in a specific class of device or a specific therapeutic area?\u00a0 <\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">Shrinidh Joshi,<\/a> clinical research consultant and <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">freelance medical writer<\/a>\u00a0on Kolabtree, says, &#8220;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.&#8221;\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">He advises, &#8220;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\u2019s 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.&#8221;\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Transparency\"><\/span><strong>Transparency\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Honest communication and transparency is the key to a good working relationship. Shrinidh recommends, &#8220;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.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;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\u2019s also beneficial for sponsors to communicate their strategic approach going forward \u2014 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.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">&#8220;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.&#8221;\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Experience_with_regulatory_requirements\"><\/span><strong>Experience with regulatory requirements\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">While choosing a CRO, it\u2019s important to ensure that they are experts in the regulatory requirements and ethical rules that govern clinical research. In Europe, med device companies need to comply with the Medical Device Regulations and obtain a CE mark, which allows them to place a product in the EU market. Clinical evaluation forms an important part of the process, and maintaining and updating a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">clinical evaluation report<\/a> or CER is mandatory. As the MDR is still new and there is still some uncertainty about what exactly is required, it is important to work with an expert who has experience writing CERs especially in line with the new regulations. In the US, the <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/clinical-trials-guidance-documents\">FDA<\/a> governs aspects of clinical research. All clinical trials are <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-write-a-clinical-trial-protocol\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">required to get IRB approval<\/a>, which reviews the clinical trial protocol and ensures that the study meets ethical considerations. Ensure that you work with consultants who are well-versed with FDA pathways for approval, technical documents, clinical trial protocols and international guidelines for conducting trials. Always ask for examples of medical device clinical trials they\u2019ve worked on before and make sure what they can deliver meets your expectations.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"When_you_should_work_with_independent_medical_device_consultants\"><\/span><strong>When you should work with independent medical device consultants\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Depending on your requirements you may want to consider working with independent consultants, rather than hiring a full-fledged CRO. Maybe you&#8217;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: <\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Understanding regulatory requirements and\u00a0<\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">preparing regulatory documents<\/a><\/li>\n<li><span style=\"font-weight: 400;\">Developing a clinical trial protocol\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Preparing a <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/grant-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">grant application<\/a> or research proposal\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Performing statistical analysis and verifying outcomes\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Clinical evaluation for CERs (MDR)\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">FDA submissions\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Writing press releases and developing corporate communications about your clinical trial\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Working with medical device consultants on demand makes it easy for you to explain your requirements on a one-on-one basis and customize deliverables. You save on overhead costs and managerial spends that might come with working with a CRO. Based on the complexity of your medical device and the kind of support you require, you can choose the best approach that helps you gain maximum benefit so that you can launch your medical device with confidence. <\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><strong>Need to consult a <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">medical device specialist<\/a>? Connect with experts directly on Kolabtree. It&#8217;s free to post a project and get quotes. <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">Get started now<\/a><\/strong><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Outsourcing clinical research to a medical device CRO can be a good decision for small medical device businesses. Here\u2019s what to look for while hiring a medical device CRO or medical device consultant.\u00a0 Small-to-medium-sized medical device companies often don\u2019t have the resources to be able to hire full-time teams who can handle all the complexities<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/what-to-look-for-in-a-medical-device-cro\/\" title=\"Read More\">Read More<\/a><\/div>\n","protected":false},"author":12,"featured_media":7729,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What to look for in a Medical Device CRO - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"What to look for when hiring a medical device CRO, including advice from a clinical researcher. Also includes how to save time and costs.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.kolabtree.com\/blog\/zh\/what-to-look-for-in-a-medical-device-cro\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What to look for in a Medical Device CRO\" \/>\n<meta property=\"og:description\" content=\"What to look for when hiring a medical device CRO, including advice from a clinical researcher. 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