June 22-26: DIA 44th Annual Meeting in Boston, MA

This session will address the definition of feasibility from the sponsor, CRO, and site perspective. It will also discuss the operational processes, performance metrics, and tools used by each stakeholder to conduct feasibility. Ultimately, the common goal is good data, produced by the site, monitored for compliance by the CRO, and compiled/analyzed by the sponsor. A common understanding to each other’s needs and processes allows all stakeholders to come together as better business partners.

As regulatory processes and documents become more global, there is, by necessity, growing need for standards. These better ensure that across the industry and across geographic regions, the representation of clinical data become uniform. This should expedite the preparation and review of the regulatory documentation. The panel will review standards that have emerged during the current phase of globalization, focusing on CDISC, ICH, Publication, Reporting, Posting, Authorship, Nomenclature, and electronic filing guidance.

The success or failure of any project often turns on how effectively a true partnership was established. Too often there is not equal investment among stakeholders. This results in unequal distribution of responsibility, accountability, and ownership. A model of success represents partnership among service providers and clients. A panel of experts will represent different perspectives across a number of outsourcing models in the pharmaceutical industry. They will address differences among the models, how to overcome perceived obstacles to partnership, and how to develop approaches to best ensure success for all parties.

For more information on the 44th Annual DIA Conference visit the web site http://www.diahome.org/DIAHome/FlagshipMeetings/home.aspx?meetingid=14235