Lumis’ Content Hub: Blog

Heike Schön, managing director, Lumis
Interview with Heike Schön, Managing Director 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!

Interview with Heike Schön, Managing Director 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
Decentralised Clinical trials – oversight and vendor management Clinical Trial Oversight Management
Participants in a decentralised clinical trial
- The concepts around decentralised 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 decentralised clinical trials experienced a large upswing.

Decentralised 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

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