One company – with different labs – in different countries – using different processes – and different systems. Harmonization is needed. And the larger the organization, the larger the potential performance and business benefits harmonization will bring.
Let’s take the example of an established global pharmaceutical company.
Operations are carried out in an environment of mergers, acquisitions and continual organizational and infrastructure changes. There’s a lack of standardization, and high demands on productivity due to an increasing number of drug development projects.
The result is a culture of “My process, my data.” Local systems have become highly customized, there’s little systematic integration of information, limited degrees of automation and very little assimilation between labs.
What should be done?
There are a number of integrated steps the organization could take to generate greater sustainable value.
- Start by creating a vision; “To capture, structure and secure instrument and laboratory data in ONE system, according to ONE process, using ONE set of business rules.”
- Define a systematic (yet flexible) roadmap for change. Harmonization is likely to require at least 3-5 years.
- Consolidate systems by adopting a principle of buy not build.
- Create a dedicated enabling service organization supported by IS/IT
- Establish long-term relationships with external vendors and CRO/CMOs
In addition to realizing a wide range of direct benefits associated with usability, quality and cost avoidance, this approach will also deliver some powerful business level advantages:
- Effective company-wide utilization of informatics solution investments
- Effective business development utilizing laboratory information
- A foundation for achieving continuous improvement of all lab-based operations