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Medical Device and Package Integr y Test g grity rity Integrity Testing Information Technology maintaining links to CDISC (Clinical Data Interchange Standards Consortium) standards. Instead of downloading CDISC guides to the local server, for example, it is better to reference the CDISC website that contains links to the most current CDISC guide versions. This process becomes more vital to ensure that all clinical team members access the most current version of CDISC. In addition, by categorizing and organizing CDISC references, smarter companies guide employees to standardize the process. With SDTM (Study Data Tabulation Model) and ADaM (Analysis Data Model) dataset requirements, having access to downloadable CDISC files and free cloud-based tools will help leverage industrywide resources. Examples of free cloud-based tools to help create and validate SDTM and ADaM datasets include CDISC Express and OpenCDISC. Through time and experience, new statistical programming tips, techniques, and knowledge can be added to the wiki system for future reference. Typically, individuals save several websites as their favorites. But with wikis, teams have a method to store and search hundreds of websites for better utilization of Internet resources. In addition, wikis are great for saving images of study diagrams, process flowcharts, graphs, and summary tables. Including images with the appropriate text and hyperlinks, for example, can help reinforce the understanding of complex clinical study designs. ENSURE FDA COMPLIANCE FOR TRAINING t Headspace and M.A.P. t Permeation O2, CO2, Moisture t Leak, Creep and Burst t Microbial Barrier (ISO 11607) t Odors and Volatiles Instruments and Testing Services Test. Measure. Analyze. 763.493.6370 Email: info@mocon.com www.mocon.com 58 LifeScienceLeader.com Effective wiki systems not only increase productivity of FDA submissions, but also help ensure FDA compliance on training requirements. Automatic email alerts and monthly newsletters remind team members of new training topics and schedules for completion. As with typical LMS (learning management system) applications, cloud-based tools can keep track of training compliance records for each employee. Managers have administration rights to view and ensure 100 percent compliance for their departments. In addition, managers can establish a mentoring program using job aids to better align senior programmers with junior programmers. By assigning junior programmers with reading tasks about proven technical techniques, for example, senior programmers can have higher expectations with minimum supervision. In this environment, junior programmers benefit from both worlds — formal and informal on-the-job training. These are a few examples of innovative ways cloud-based tools have enabled pharmaceutical companies and CROs to better manage clinical studies and still provide high-quality deliverables for FDA submissions. Smarter organizations are making it easier for their workers to access the best cloud-based tools. For the pharmaceutical industry, this extends to providing online statistical programming e-guides, training, and support for any technical issues. Online e-guides provide concise and numerous programming examples, templates, and brief text that solve real-world programming challenges. Monthly, live, online training sessions encourage more sharing of tips and current questions and answers. Previous online training sessions can be recorded and cataloged for new team members to view. With these cloudbased tools, technology and shared resources are better leveraged for more just-intime response and minimum expense. Finally, it is important to point out that cloudbased tools can support groups as small About the Author as 3 to as large as Sunil Gupta is the founder of www.SASSavvy.com and 300 team members senior SAS/CDISC consultant at Gupta Programming. He without requiring has expertise in training, automating, standardizing, and validating clinical data, analysis, and reporting a dedicated staff to for FDA submissions. maintain application tools. September 2013