The International Consortium on Innovation and Quality in Pharmaceutical Development (IQ Consortium) is putting in place a separate foundation to focus on developing a common format for generating, storing, retrieving, transmitting, analyzing and archiving pharmaceutical analytical lab data and the reports generated from that data.
Attacking the problem of the inefficiencies and limitations created by the current disconnects between the pharma labs and the inability to interlink the information that they are generating has been high on the IQ Consortium’s priority list.
The magnitude of the challenges involved has prompted the consortium to establish a sister organization dedicated to addressing them.
The goal of the newly established “Foundation for Laboratory Data Standards” (FLDS) is to create an “interoperable open-source laboratory information framework” that will provide significant industry-wide financial and innovative technical benefits in the lab data and information management arena.
The problems FLDS will focus on derive from the fact that data generated in laboratories across the industry by various types of analytical instruments have no common standard for file formats or database structures.
The absence of a common format, IQ stresses in its proposal to form FLDS, impedes data exchange, data archiving, data re-analysis, custom data analysis, and data conversion from older to newer versions of software, or between different software applications.
The lack of standardization, the proposal notes, also leads to “critically important” documents, such as stability reports, certificates of analysis, and regulatory submissions, “that are derived from multiple sources of raw laboratory data and are costly to create.” These costs impact operations within a company’s labs, between partnering companies, and between a company and contract research organizations (CROs).
Obstacles for data exchange also contribute to “missed opportunity” costs because they make it difficult to collaborate and innovate.
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