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Innovating Technology -Based Metadata Solutions for Improved Data Analysis

Douglas Barta, CIO, PAREXEL International

Douglas Barta, CIO, PAREXEL International

Simplifying the Drug Development Journey with Technology

Technology plays a critical role in helping the biopharmaceutical industry navigate the complex drug development journey. There are a number of technologies available to help simplify the process, many of which can make drug development faster, more precise, trackable, and productive. All which ultimately mean we can simplify the journey between science and new treatments to help our clients bring new drugs to market for patients. Platforms and applications are designed to improve how biopharmaceutical companies perform clinical trials, control and share data, track and report patient outcomes, and manage regulatory information worldwide. For example, at PAREXEL, we developed the Perceptive MyTrials® platform. MyTrials was originally developed as an internal tool, and we rapidly saw that the platform could offer biopharmaceutical companies seamless access to all of their clinical trial data using PAREXEL’s integrated suite of eClinical applications through a single sign-on. This enables access to Electronic Data Capture (EDC), Randomization and Trial Supply Management (RTSM), clinical trial management, medical imaging, and electronic Patient-Reported Outcomes (ePRO) programs to manage trial data more efficiently and effectively. The platform is built around newer advancements using Social, Mobile, Analytics, and Cloud (SMAC). Proactive and constant web listening is critical for gaining insights into how patients will view their trials and how investigators will react. Not only does this guide feasibility estimates, but it also helps position clinical trials with these two critical groups when reaching out to them. Related to recruitment, PAREXEL is leveraging Facebook and other Social media apps, as well as its own web-based platform, to recruit and retain patients. Mobile technology and Short Message Service (SMS) is used for patient retention. We have created new analytics for investigator intelligence services, risk-based monitoring, and data surveillance. We leverage Cloud technologies throughout all areas of MyTrials. Such innovation helps to make key parts of the clinical trial process more efficient and effective.

“The introduction and the enforcement of end-to-end standards in clinical data management processes enable the efficient delivery of standards compliant data output”

Innovating Technology-Based Metadata Solutions

As one of the largest Contract Research Organizations (CROs) in the world, PAREXEL provides drug development services during all phases of the process, including strategy, clinical trial management, data management, biostatistical analysis, regulatory affairs, medical marketing, training, publishing and advanced e-clinical technology solutions.

The Company operates in 81 locations in 51 countries around the world, and has 15,980 employees. As such, it is essential to grant all employees access to world-class technology so that they can collaborate with colleagues and clients around the world regardless of location. Companies with a global footprint must connect employees through common processes, standards and technology so that regardless of where business is conducted, the same standards of quality apply. As an organization expands globally, its technology infrastructure should mature in tandem to ensure resources remain uniform across the board. Significant IT challenges impacting the operations of a life sciences company can occur in the area of metadata management. If a biopharmaceutical works with many vendors it is very typical for an IT department to face challenges to bring data together to lock and submit studies quickly and efficiently. Clinical data management activities are performed to produce data output which can be used for downstream data activities such as data analysis, reporting, or visualization. To simplify downstream data activities, it becomes increasingly important that the data output format follows strict standards. The introduction and the enforcement of end-to-end standards in clinical data management processes enable the efficient delivery of standards compliant data output.

At PAREXEL, we are continuously innovating our technology-based metadata/library solutions to expedite data analysis process, ensure quality in our data analysis, and stay ahead of cutting-edge ideas for clinical trials.

A Sense of “Intrepreneurship” that Benefits the Company

As CIO of a leading Contract Research Organization (CRO) to the biopharmaceutical industry, it is essential for technology to keep pace with corporate growth. I advise CIOs of a rapidly growing company to keep track of several important questions related to company growth: Are the available IT solutions scalable for anticipated growth? Can your backend infrastructure keep up with the growth? Can you imagine new technology solutions—ones that are not available yet, but that will permeate your corporate culture—and are you ready to take on the increased bandwidth or related needs? It is also very important to understand that your business today will likely look very different in one or two years. In addition to the rapid advancement in technologies, you may have acquired other assets that need to be transitioned and integrated into your metadata framework. This is an area that PAREXEL specializes in to ensure you have a stable partner with deep outsourced asset transition services that will help both the small and large pharmaceuticals in these changing times. If the rapidly growing company was a global or globalizing organization, I would advise the CIO to ensure that when operating in multiple locations, employees must be aligned on processes and strategies from an IT perspective. For example, are disparate technology systems connected so that employees have unified access? Are multiple services within your platform purchased from a common vendor? Are processes set up for success at a global level? To achieve this, employees must be able to communicate and collaborate, regardless of language or location. Finally, some of the best advice I received early in my career, I like to pass on: creatively foster innovation within your teams. A sense of “intrepreneurship” contributes to a more exciting workplace and has significant benefits for the Company. For example, a team at PAREXEL developed Perceptive MyTrials as an internal solution to help the Company’s Clinical Research Services organization more effectively view and manage the massive amounts of data generated during a clinical trial. In essence, the goal was to ensure various technologies were “talking to each other.” Following development and internal testing of the solution, PAREXEL integrated the technology into our innovative eClinical suite for the benefit of our clients’ studies. The innovation, teamwork, and outcome were an ideal scenario for a CIO: what began as an internal project ultimately had positive implications for PAREXEL’s clients and helped advance our technology offering.