Last month, I read an article on the announcement from Apple’s CEO Tim Cook that stated Eli Lilly bought 15,000 iPads. The article, focusing on Apple’s mobility partner program, framed this as big news about Apple. I assume this will also significantly contribute to the Apple and IBM partnership as they build big data and analytics enterprise applications on IBM’s MobileFirst for iOS app platform. But my commendation in this case goes to Eli Lilly. Some may wonder if enterprise mobility initiatives are really worth a purchase as significant as 15,000 iPads – do they really provide enough business value to justify the expense? I believe so!
While some may not want to admit it, smartphones and tablets are now an everyday aspect of our lives. However, business technology solutions often lag behind. Innovative organizations in all industries are undergoing a major digital transformation embracing the explosion of mobile technology. The advantages of doing so are engaging customers and making it more convenient for employees to get work done.
Appian is a software vendor dedicated to providing an application platform that addresses challenges businesses are facing with people, process, and data. The platform offers solutions for rapid application delivery, BPM, case management, cloud, and mobile. Appian was rated #1 in BPM and Platform as a Service and named a Leader in Dynamic Case Management solutions by Forrester. Perficient is also a service integration partner of Appian, dedicated to helping our customers address industry challenges related to technology initiatives on BPM, cloud, and mobile.
You can download our guide to see 30 examples of digital transformation in life sciences. In this post, I will provide three use cases of how a pharmaceutical company like Eli Lilly can improve operational efficiency in clinical trials by adopting enterprise mobility using the Appian platform.
Appian is a single platform that features a build once, deploy everywhere capability, which means any application built for desktops are available on mobile devices without any additional configurations. Additionally, by building applications on Appian, those applications can be supported by business processes which ensure that rules, regulations, and procedures are enforced and records that can group enterprise data from multiple sources by topic. This is on top of the Tempo Facebook-like interface that improves enterprise collaboration and increases transparency for optimal business decisions.
As part of developing a new drug, pharmaceutical companies sponsor clinical research studies. However, these studies are often conducted by Contract Research Organizations (CROs). As the sponsors, pharma companies need to ensure that the CROs are following Good Clinical Laboratory Practices (GCLP) – or research they’ve commissioned, conducted over several years and costing millions of dollars, can be rejected by the Food and Drug Administration (FDA). In some cases if federal regulations are violated, laboratory directors can even face jail time. Here are some of the ways mobile apps built on business process management (BPM) can benefit a pharmaceutical company around Clinical Operations and CROs.
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Improve Regulatory Compliance
The data generated by clinical trials is vital to our ever-expanding scientific understanding of health, but that data is also subject to strict regulations and ethical standards. Because of these standards, it is critical that everyone in a lab and field workers follow the rules and regulations. Enter business process management from Appian, a low-code, model-driven interface allowing users to create intuitive, interactive screens using drag-and-drop functionality. When an interface is published, it’s available on desktop and natively on mobile devices without any additional configurations. This means business applications can contain built-in rules for consistency and reliability across device. More specifically, a pharmaceutical company can centrally control when and how clinical data is collected by prioritizing the sites a field worker should visit and the information to collect. Native mobility also enables workers to upload information with a device camera, voice memos, and Bluetooth connected devices. Data can even be collected remotely through IoT devices. Mobile devices connected to BPM ensure industry best practice across device and worker for improved regulatory compliance.
As pharmaceutical companies are increasingly opting to have Contract Research Organizations perform most of their clinical trials, their employees are less focused on running their own labs and more focused on auditing research labs for Good Clinical Laboratory Procedures (GCLPs). Transparency in Clinical Trial Management Systems (CTMS) is vital for research to be accepted and approved. Mobile applications driven by BPM can be used to not only enforce GCLP compliance but also gain real-time visibility into required information and analyze risk across organizational silos. Social collaboration that includes hazards and alerts can be incorporated in business processes proactively drawing attention to impediments.
An additional example is according to FDA regulations, sponsors of New Drug Applications (NDAs) must present a summary of safety and effectiveness data broken down by demographic subgroups. Appian’s out-of-the-box Reports Designer can access enterprise data from external sources and pull it into Appian as a central source. On top of that, out-of-the-box functionality with interactive reporting can be built to increase transparency on race, ethnicity, sex, and age of participants represented in trials.
Enhance Operational Efficiency
The clinical trial start up process is impacted by the type of research and obviously regulatory compliance. In an industry of constantly-changing regulations, a platform with the ability to easily design, change, and build applications is vital for life sciences companies. Reducing start-up cycle time is another benefit of adopting enterprise mobility. Companies can build electronic forms for mobile devices for both research subjects and workers to enroll in clinical trials. With that electronic information, a patient can be easily matched with specific trials. And there are specific standards around those forms as well. The federal government requires everyone working on a research study to complete Form 1572, Statement of Investigator, fully and accurately. If the form is completed on a mobile device during enrollment, the pharmaceutical company can significantly increase full compliance and reduce their risk of violation.
According to Gartner, applications built with the Appian platform require the fewest number of resources compared to the other leaders in BPM. For life sciences companies, the Appian BPM platform can be used to quickly build and change applications around all aspects of clinical operations like Clinical Trial Planning and Design, Site Start Up, Patient Engagement Services, Photoacoustic Imaging (PAI), and many more.
Much kudos is due to the Eli Lilly’s leadership in their understanding that for an organization to continually improve – and in turn, achieve and sustain success – it needs to embrace enterprise mobility and the benefits that go along with it.
Register now for our upcoming webinar on how to automate clinical, safety, and business processes with Appian!
This is a great one. Thank you for sharing with us. The best explanation on the importance of clinical research in an organization’s BPM.