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"

Thursday, May 10, 2012

"Design" your clinical project oversight

The recent FDA guidance on "Risk-Based Approach to Monitoring" - calls for a shift from historical methods of assuring Quality via Inspection - to a more proactive approach of Quality by Design.

For small and virtual biotech companies these are approaches and principles to be very much aware of.

They allow you to focus you oversight strategy with limited in house resources by following the four basic principles of Quality by Design:
  1. A systematic approach to development
  2. Predefined opbjectives
  3. An emphasis on product and process understanding and control
  4. A foundation in sound science and quality risk management

These are great tools to ensure success of your outsourced clinical program.


FDA Guidance for Industry_Oversigt of Clinical Investigations_24Aug2011




Quality by Design in Clinical Trials
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