Lumis’ Content Hub: Blog

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

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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