Lumis’ Content Hub: Blog

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

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

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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.