Standard data formats such as PLCS, STEP and XML offer a way to archive information electronically and independently software systems. Data can be kept in a form which can be understood by systems for many years to come. PDM offers a methodology for managing and indexing the archived data.
Eurostep works with pharmaceutical companies to:
• Archive electronic data using standards
• Define clinical study data requirements
• Define pharmaceutical preparation data
• Implement product data management
• Implement a framework for XML harmonisation
The increasing need to bring new drugs to market quickly is made difficult because of legal requirements to store information about clinical studies and pharmaceutical preparations:
• Clinical and pharmaceutical data outlives the software which produces it.
• Current archiving is paper-based as a result, which is costly to store, and difficult to search when needed in a hurry.
Contact us:
Finland: Leo Torvikoski
France: Christian Giraud
Sweden: Peter Bergström
United Kingdom: Nigel Shaw
USA: Nigel Shaw