Lumis blog posts

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. 

Regulatory Pathways for Medical Device Clinical Trials Read more

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.

Transitioning to the Clinical Trials Regulation 536/2014 (CTR) – Key considerations Read more

Medical cannabis research is evolving rapidly. In this article we examine the recent developments and challenges faced, focusing mainly on Europe and the US.

Medical Cannabis Clinical Trials Read more

Recently, it was the 10-year anniversary of the founding of Lumis International. Here the founders reflect on the lessons learned during that time.

Lumis 10-Year Anniversary – The Lessons we have learned Read more

We sat down with Heike Schön our CEO 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!

First experience with CTIS – Interview with Heike Schön Read more

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.

Rescue clinical trials – how to avoid the failure of clinical trials Read more

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.

Risk-based CRO management made easy Read more

The concepts around decentralized or virtual clinical trials have been extensively developed over the last years. Especially with the start of the COVID-19 pandemic, companies have been faced with new challenges: to keep the patients in their ongoing clinical trials or even to recruit new patients for the studies. Regulatory authorities adjusted quickly to support new approaches to clinical trials and the concepts of decentralized clinical trials experienced a large upswing.

Decentralized Clinical trials – oversight and vendor management Read more

Most companies outsource their clinical trial activities, however it is the sponsor who is entirely responsible for the clinical trial performance. Without mirroring the work of the CRO

Key Performance Indicators for effective Clinical Trial Oversight Management Read more

The number of small Biopharmaceutical and Medical Device Companies (“small sponsor companies”) conducting early stage clinical trials is increasing. Outsourcing and vendor management are essential for survival of these companies, since they are usually facing the challenges of limited budgets and resources.

Sponsor-vendor relationship – it takes two to tango (at least) Read more