With 18+ years of Clinical Research experience from academia, pharmaceutical and biotech industry, this blog is a place to share my experience from managing industry sponsored clinical research projects in large pharma, small and virtual biotech companies.
This blog does not intend to discuss indication or project specific elements such as Clinical Development or Regulatory Strategies. These are important aspects of Clinical Research Management and key for the overall success. However, they are usually not generalizable and typically considered confidential.
The ability to execute efficiently, however, is the underlying key to success as measured by timelines, budget and quality – especially in small and virtual biotech companies. Here organizational support is limited – and the Clinical R&D manager has to rely on his experience and capabilities in managing complex projects through contractors.
This blog attempts to make a difference by focusing on those generic aspects of Clinical Research Management that go across indications, clinical development stages and trial complexity. They are in one way or another relevant to almost any clinical research project.
Especially in small and virtual biotech companies execution risk is the greatest risk. Let’s use our skills to make sure that if a project has to fail – it fails for scientific reasons and not due to lack of effective execution.
This blog represents my personal experiences and views.
Every team and every project has its own strategies, experiences and ways of doing things.
My intention is solely to share my experience with those who find it of value – and for those who may find inspiration for how to find solutions in their teams and organizations.
Likewise, I hope to be able to collect inspiration to my work through interactions on this blog.
There are 10 reasons to start blogging:
6. Be challenged
7. Be supported