This week I am giving a speech at the "Outsourcing in Clinical Trials - Europe 2012" conference in Zurich, Switzerland:
http://www.arena-international.com/octeurope/
At the conference, I will make a speech about my recent success with managing the planning and execution of a large (> 300 patient) phase II trial in a small virtual biotech company.
The fact that I was invited to share my experience with an audience of colleagues inspired me to start this blog.
At least in Scandinavia, the biotech business is currently undergoing a paradigm shift towards more focused - even virtual companies - with maybe only one compound in clinical development - where a small, experienced team can drive a clinical project towards the next inflection point in a fast and cost-efficient manner.
With this blog, I hope to be able to inspire friends and colleagues, by sharing my ideas, views, and experiences.
At the same time, I wish that opening this window to the world, will inspire others to share their ideas, views and experiences with this blog - so that in the end we all can improve our skills, increase our network, share our knowledge and become more successful.
With the increasing implementation of the virtual model for managing complex clinical programs in biotech with small and experienced teams, not only strategic clinical development and regulatory strategies, but smart and cost-efficient execution through successful stakeholder and vendor management becomes the key competence.
My hope is that everybody who comes across this blog will support it by sharing his/her own ideas, views and experience, so that it may become a valuable resource for Clinical Research Management professionals in virtual and small biotech organizations.
WITH 17+ 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 SMALL AND VIRTUAL BIOTECH COMPANIES
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DESCRIPTION
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.
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.
This blog has the scope to support small and virtual teams handling the challenges of managing the outsourcing of complex clinical projects without a lot of organizational support.
In small and virtual biotech execution risk is the greatest risk. This is why I call the blog "Advanced Clinical Research Management"
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