Ofni Systems to Exhibit at 2012 SCDM Annual Conference Press Release

Director Wilson introduced the topic of PDUFA V and other presenters went into more detailed commentary. One FDA presenter talked about the increased communication allowed between the FDA and Sponsors in order to ensure timely drug development. A representative of CDRH noted that the law allowed for significant expansion of that branch of the FDA. Another presenter talked the initiative to interconnect federally administered databases with prescription drug information and allow the FDA access to them. Some of the databases mentioned were Medicare, Medicaid, and armed forces. Overall, it appeared that the FDA presenters were looking forward to working on the various measures prescribed in the new law.

Director Wilson also introduced the theme that the FDA was further increasing the trend of expanding engagement with industry and other stakeholders. In addition to the expanded cooperation initiatives mentioned in the talks about PDUFA V sections, one of the major partnership goals is the development and implementation of clinical data interchange standards that are widely used and accepted. The primary discussion was the expansion of implementation of Clinical Data Interchange Standards Consortium (CDISC) standards. Related topics such as integration of clinical datasets based on CDISC standards and datasets based on Health Level Seven International (HL7) standards were also discussed.

In summary, the FDA talk was an interesting sampling of thoughts and initiatives from multiple viewpoints that showed the agency is pursuing both many department-dependent initiatives and some strong agency-wide collaborative efforts with pharma and other stakeholders.

Ofni Systems would like to thank all of our friends who came by to discuss clinical data mangement, Ofni Clinical and services provided by the Ofni Clinical Group.