Lumis blog posts
Lumis 10-Year Anniversary – The Lessons we have learned
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
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!
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Rescue clinical trials – how to avoid the failure of clinical trials
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
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.
Decentralized Clinical trials – oversight and vendor management
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.
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Key Performance Indicators for effective Clinical Trial Oversight Management
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
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Sponsor-vendor relationship – it takes two to tango (at least)
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.
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Are you ready to outsource your clinical trial?
Outsourcing of clinical research to a CRO or other vendors is a critical business process with a high impact on the outsourcing company and its procedures, especially for small sponsor companies.