Lumis’ Content Hub: Blog

Transitioning to the new Clinical Trials Regulation (CTR)
Transitioning to the Clinical Trials Regulation 536/2014 (CTR) – Key considerations News
Transitioning to the new Clinical Trials Regulation (CTR)
- 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

Clinical trials of medical cannabis
Medical Cannabis Clinical Trials Clinical Trial Oversight Management
Clinical trials of medical cannabis
- 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

The founders of Lumis
Lumis 10-Year Anniversary – The Lessons we have learned News
The founders of Lumis
- 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

Heike Schön, managing director, Lumis
First experience with CTIS – Interview with Heike Schön News
Heike Schön, managing director, Lumis
- 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!

First experience with CTIS – Interview with Heike Schön Read More

Half of wooden peg set OK, other half falling representing the failure of a clinical trial
Rescue clinical trials – how to avoid the failure of clinical trials Clinical Trial Oversight Management
Half of wooden peg set OK, other half falling representing the failure of a clinical trial
- 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

Risk Based CRO Management is a juggling act
Risk-based CRO management made easy CRO Management
Risk Based CRO Management is a juggling act
- 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

Participants in a decentralised clinical trial
Decentralized Clinical trials – oversight and vendor management Clinical Trial Oversight Management
Participants in a decentralised clinical trial
- 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

Key Performance Indicators for effective Clinical Trial Oversight Management 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

Key Performance Indicators for effective Clinical Trial Oversight Management Read More

Sponsor-vendor relationship – it takes two to tango (at least) CRO Management
- 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

Are you ready to outsource your clinical trial? Outsourcing in Clinical Trials
- 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.

Are you ready to outsource your clinical trial? Read More

Not sure what a specific regulation says or want to know more about the meaning behind a certain term? Visit our glossary.

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