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Information Technology How Cloud-Based Tools Can Help With FDA Compliance By Sunil Gupta T hese days, enforcing FDA compliance and mentoring new team members are more challenging than ever, thanks to a workforce that is more remote, international, and diverse. Additionally, today's Internet technology is more global, sophisticated, and secure. With these changes, pharmaceutical companies need to adapt to grow and ride the cost-conscious trend just to survive. Cloud-based tools, such as wikis, offer a paradigm shift in project management, FDA compliance requirements, and job aids for mentoring new employees. With the lack of face-to-face interactions, more emphasis is placed on Internet technology to help automate and standardize repetitive tasks. For example, project management tools, such as Projecis, capture and communicate important milestones and deliverable details. By using a cloud-based project management application, that important data is always available and automatically backed up. It's those types of benefits that often empower small biotech companies, for example, to outsource their IT infrastructure to gain powerful computing platforms at a minimum cost. As an extension, some vendors also offer cloudbased EDC systems to help automate the collection and "cleaning" of clinical data. In the pharmaceutical industry, practical applications of project management tools include tracking clinical data issues or issues related to validating datasets or summary tables. For CROs with a global workforce, having an intuitive, centralized data-management analysis system helps to increase user compliance. This 56 LifeScienceLeader.com is important to track access and updates to clinical data and statistical programs that summarize results. With a centralized system, these validation issue trails can be tracked for QA or FDA auditing purposes. For pivotal clinical studies with large lab datasets, for example, there is an extra advantage of using cloud computing. For example, with advanced signal detection and hypothesis generation, high-speed computers are ideal to optimize repeated tasks on large amounts of data. From an exploratory point of view, this opens new opportunities for comprehensive analysis of any drug-to-drug interaction within any combination of subgroup or stratification. USE WIKIs TO CREATE DYNAMIC SOPs Building an online, customized wiki system (without being a webmaster) to support SOPs (standard operating procedures) in statistical programming development and validation is another example of how you can use the cloud. Wikis can be designed to access just-in-time information based on user-defined topic categories. Instead of static SOPs, today's SOPs need to be "alive" and build on lessons learned September 2013 from FDA submissions. By having access to frequently asked questions and crossreferenced indexes, team members are more empowered to find solutions for similar clinical study-related questions. Ideally, with a user-friendly wiki, statistical programmers and statisticians should be able to look up technical answers to the correct programming syntax with a few mouse clicks. Wikis are the equivalent to docstoc.com, being a repository of knowledge for the pharmaceutical industry. Wikis also greatly reduce time spent on "reinventing the wheel" and allow statistical programmers to focus on more challenging and complex summary tables and analysis. By having immediate access to best practices resources and references on the Internet for lab conversion and normal ranges, team members can have greater confidence to complete typical tasks in an expected time frame. When senior programmers add insights to a lab data analysis checklist, they create more meaningful instructions. Essentially, this process, over time, builds an online knowledge base that can be harvested by anyone on the clinical or management teams for tracking the progress of the study. Wikis are also ideal for accessing and