Lumis’ Content Hub: Blog
Lumis Is Launching a New Authorised Representative Service
News
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Are you a non-EU medical device manufacturer? If so, Lumis could be your gateway into Europe via our new authorised representative service.
In accordance with Article 11 (1) of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), any manufacturer not established within an EU Member State must designate an Authorized Representative to market their devices within the EU. …
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Trends in Outsourcing Clinical Trials: A Comprehensive Overview
Outsourcing in Clinical Trials
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Outsourcing clinical trials has become an increasingly prevalent trend not only in the pharmaceutical industry but also increasingly at small to midsize biotech and medical device companies. As the complexity of drug development and regulatory requirements continue to grow, companies are turning to specialized external partners to conduct clinical trials more efficiently and cost-effectively. …
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Overview of the Orphan Designations Webinar
News
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This webinar is divided into several sections, either focusing on different aspects of orphan designation (OD) in key global markets or rare disease trials. The goal is to provide attendees with a comprehensive understanding of the benefits, application processes, and strategic implications of securing orphan designations globally. …
Regulatory Pathways for Medical Device Clinical Trials
News
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This is a comprehensive review of the process, pitfalls, and procedures to get study approval for medical device clinical trials. We look into the future and unpack the present, in terms of European medical device regulation and the local regulatory landscape. Along with the intricacies of EU MDR 2017/745 medical device regulations, we provide an important summary of medical device study classifications and the corresponding submission pathways. …
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Transitioning to the Clinical Trials Regulation 536/2014 (CTR) – Key considerations
News
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Transitioning studies approved under the Clinical Trials Directive 2001/20/EC (CTD) to the new Clinical Trials Regulation 536/2014 (CTR) is a common challenge for sponsors. This blog will provide an overview of how to transition a study to the CTR and some key considerations. …
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Medical Cannabis Clinical Trials
Clinical Trial Oversight Management
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Medical cannabis research is evolving rapidly. In this article we examine the recent developments and challenges faced, focusing mainly on Europe and the US. …
Lumis 10-Year Anniversary – The Lessons we have learned
News
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Recently, it was the 10-year anniversary of the founding of Lumis International. Here the founders reflect on the lessons learned during that time. …
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First experience with CTIS – Interview with Heike Schön
News
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We sat down with Heike Schön our Managing Director to discuss how our clients can remain inspection ready this year, Clinical Trials Information System (CTIS) and to find out what Lumis have in store for 2023! …
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Rescue clinical trials – how to avoid the failure of clinical trials
Clinical Trial Oversight Management
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Considering the already high costs involved in conducting clinical trials, the complex regulatory environment, expectations of investors and other stakeholders, the lack of early warning systems of potential clinical trail failures is surprising. In this article we discuss possible reasons for failure and how to better manage these trials. …
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Risk-based CRO management made easy
CRO Management
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Following the implementation of the new medical device regulations and the revised ISO 14155:2020, the planning and implementation of clinical investigations are a major challenge, especially for small and midsize medical device enterprises (sponsors). Here we walk through how to make the process easier. …
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