Standards support has become a key focus in streamlining the clinical trial process, according to service provider BioClinica. "Unfortunately, this is often a difficult undertaking, especially when plates are full and budgets are challenged," says Mark Weinstein, president and CEO, in an announcement. He challenges life science companies to prioritize the implementation of standards for data acquisition, exchange and submission. Doing so will yield a competitive advantage, he says. It will also simplify processes and decrease costs during trials.
Among standards-oriented announcements at DIA is the NextDocs Regulatory Document Management System, which will ship this summer with pre-configured support and validation documentation for the DIA Electronic Document Management (EDM) reference model. The provider of 21 CFR Part 11-compliant Microsoft Office-based solutions says it will also provide fully-configured sample implementations, including folder structures, document types and metadata that embody best practices and standard deployment scenarios.
The reference model is a DIA-driven initiative to develop a taxonomy/metadata reference model for electronic document management. It represents a common approach to implementing regulatory and clinical content management solutions by standardizing system specifications and configurations.