Lumis’ Content Hub: Blog
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. …
Decentralised Clinical trials – oversight and vendor management
Clinical Trial Oversight Management
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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. …
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Key Performance Indicators for effective Clinical Trial Oversight Management
Clinical Trial Oversight Management
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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)
CRO Management
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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 in Clinical Trials
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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. …
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