PAREXEL's Kate Trainor, VP to Speak at DIA 2014
Hi! I'm Kate Trainor, and I'm VP of Project Leadership and Technology in Peri Approval Services at PAREXEL International. I'm speaking at DIA at the end of June, to address some regulatory document management topics in Late Phase Research. I'm speaking with folks from sponsors and a vendor who have significant expertise in the space. Late phase clinical research, specifically in the peri and post approval space, tends to have some common characteristics. This may include high volume of sites and patients, reduced regulatory rigor, and a global site community which is focused on patient treatment, less so on research and technology to support research. Sponsors invest huge budgets to ensure these are run successfully, to support their business, product and commercialization needs. Regardless of the typical scenario -- regulations must be followed, and the documentation supporting the study must be managed, processed and stored in accordance with regs. There is some low hanging fruit in this area, including standard technologies that are familiar to all users, such as those on the web, in the form of portals with workflow, integrations and electronic signatures. There are also some simple best practices that can help manage large volume of material. Focusing on fundamentals can help to provide high quality materials, and efficiencies in reg doc management. Come join us at DIA, on Wednesday at 3:30 PM, and I'll see you in San Diego!