Magazine Article | August 30, 2013

How Cloud-Based Tools Can Help With FDA Compliance

Source: Life Science Leader

By Sunil Gupta, founder, and senior SAS/CDISC consultant, Gupta Programming.

These 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 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 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, 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 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
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 as 3 to as large as 300 team members without requiring a dedicated staff to maintain application tools.