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Research Development & Clinical Trials sees that data entry took three weeks to do at all but one site, which finished in one week. An anomaly like this should prompt the monitor to check into whether there is a systemic problem, fraud, or something else. With the right analytic tools in place, potential issues can be seen and resolved before they escalate. All of this data presents a challenge for executives and project leaders: With so many metrics across multiple domains, how do you boil them down into something useful? Each study sponsor must decide how to weigh certain metrics at the program and site level and even by study phase. Tools are available to execute the plan in the field and guide monitors at the site level. The EDC system guides them as to what data needs to be verified, and a robust CTMS collects operational data to drive the process. Reporting and analytical tools are available to aggregate data across multiple systems and even multiple studies. The aim is to get a 360-degree, high-level, real-time view across all of your clinical trials with the ability to drill into specific studies and sites to take action. RESHAPING THE MONITOR'S ROLE Monitors have been conditioned to check every data element in the casebooks they review. This new risk-based approach transforms their role. Monitoring this new way requires a behavioral as well as cultural shift, one that takes some getting used to with new thinking on every- one's part. Reduced SDV allows monitors to focus on more important site activities of higher value. With a solid plan and the right tools in place, monitors can be selective in what they review, based on a documented and objective monitoring plan. ACROSS-THE-BOARD ADVANTAGES Simply put, this is a better way of monitoring and a more effective use of resources. Efficiency, quality, and the ability to scale and run studies without unnecessarily overburdening personnel are just some of the advantages. As monitors visit sites less frequently, it will also lower costs. Finally, from a clinical operations perspective, leveraging technology makes better use of data, allowing an organization to detect problems earlier, make more informed decisions, and efficiently plan for future studies. About the Authors Chip deVillafranca brings more than 30 years of experience to lead product management for BioClinica's eClinical solutions. Prior to BioClinica, he worked for Phase Forward and Oracle. Jonathan Andrus manages study and project operations for the eClinical Division of BioClinica. He joined BioClinica in 2003 as V.P., QA and corporate compliance. World's Largest Vaccine Conference March 24-26, 2014, Marriott Wardmand Park Hotel, Washington D.C., US Covering everything from the latest R&D; to manufacturing to the corporate vaccine development strategies you'll be sure to find answers to all your questions. Over 70 speakers include: Dr Marion F. Gruber, Director, OVRR, CBER, FDA Dr Gregory A. Poland, Director of Mayo Vaccine Research Group, Mayo Clinic Register now to secure your place. Register now and save - on your phone on your smartphone to register. Don't have a smartphone? You can also register and get the offer on our website: www.terrapinn.com/wvcw quote voucher code LS01. Dr Rino Rappuoli, Global Head of Vaccines Research, Novartis Vaccines and Diagnostics Find out more on the website: 2014 sponsors include www.terrapinn.com/wvcw February 2014 LifeScienceLeader.com 45