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"

Tuesday, May 22, 2012

How to define a virtual company

While working in a fully virtual company the ongoing debate about pro's and con's of "virtual biotech companies"continues to raise thoughts.

First of all one needs to define "virtuality".

I work with four levels of virtuality:

1. Independency from geographical location

2. Project teams composed of a mix of full time employees and contractors

3. Projects orchestrated through a mix of insourced and outsourced tasks, responibilities and resources

4. IT platforms as cornerstone of team and project management and communication

In essence, technology and globalization provides today a wide range of tools and network capabilities allowing you to mix all four levels of virtuality - depending on your strategy and needs.
In reality, I believe all (biotech) companies today apply a certain level of virtuality to most of their projects.

However, in a fully virtual biotech company you can take the concept to the extreme.

In my current company the management team is geographically dispersed. The clinical project team conists of contractors only and the projects are outsourced with a mixture of tasks and responsibilities split between the internal team and the functional service providers.

With this approach we secure a high level of involvement and leadership, combining it with effective cost control, flexibility and quality control while experiencing significant project progress. And - in contrast to most peoples immediate believe - the total budget is smaller than with other models.

The fully virtual biotech model is not a longterm solution for a company.

Limitations are obviously high communication, coordination and management demands.

Nevertheless, for start up situations or short term concept evaluation projects - it definitely is a viable approach.


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