October 30, 2017
Clinical research technology is expanding, and there is now infrastructure to back it. Last week, Parexel, a global clinical research organization, announced a new partnership with Microsoft to develop innovative cloud-based services for their clients. The collaboration will bring Parexel’s current tech offerings to the Microsoft Azure cloud platform and catalyze new developments aimed at enhancing participant engagement in clinical trials, and streamlining drug development.
The partnership combines Parexel’s extensive clinical research network—spanning 85 offices in 51 countries—with one of the largest technology enterprises in the world. Microsoft currently employs over 124,000 people worldwide and generated net revenue of $89.5 billion last year. The company touts 90% of Fortune 500 companies use its Azure cloud platform. Parexel itself has built an extensive portfolio over the past 30 years, offering a range of services for each stage of drug development, including cloud-based data collection and management tools through Parexel Informatics, its technology subsidiary. Parexel has nearly 19,000 employees worldwide.
“As Microsoft thought about expansion into the life sciences market, partnering with Parexel was a natural choice due to its deep biopharmaceutical expertise, established global reach and its clinical and regulatory technology domain expertise,” said Neil Jordan, general manager, Worldwide Health Industry at Microsoft.
As a first step, the companies are working to onboard Parexel Informatics services to Azure. “Microsoft and Parexel teams are already working together to improve the usability and design of current Parexel Informatics technologies with Azure,” Jordan said. “Looking ahead, we will jointly develop entirely new patient-centric solutions. … This includes driving more efficient and adaptive clinical trials and optimizing the use of real world data.” According to Jordan, such technologies will “help the industry deliver on the promise of personalized medicine.”
“Microsoft and Parexel are aligning across multiple streams, from research to development, to engineering, to client management,” added Xavier Flinois, president of Parexel Informatics. “While this is the largest collaboration between the two companies, this is not the first alliance between Parexel and Microsoft; this collaboration is based on the existing synergies and cultural alignment between both enterprises.”
The alliance reflects a growing trend in clinical research. Agencies of all types—including regulatory bodies—are teaming up to keep pace with technology. From patient recruitment aids to electronic data capture and management, clinical research is turning toward centralized, cloud-based tools. “The health and life sciences industries are in the early stages of digital transformation, combining digital services with traditional products, and using technology to drive improvements in quality, efficiency and safety,” Jordan said.
Migrating to the cloud is now a standard practice across industries,” said Rob Petrie, CTO at PPD, a global CRO with approximately 20,000 employees. “However, simply moving to the cloud isn’t innovation; rather, it is how the cloud is used.” According to Petrie, PPD has collaborated with data providers for several years to support rapid data analysis, improve patient enrollment and even incorporate direct data collection from patient wearables.
With so many new platforms and products, there has been an explosion of data available to clinical researchers—and potentially companies. Cloud platforms routinely contain datasets on the petabyte scale. “Big data does not always mean bigger results or inferences,” cautioned Carl Moons, Ph.D., professor of Clinical Epidemiology and director of Research at the Julius Center for Health Sciences and Primary Care at University Medical Center Utrecht. He pointed to the importance of study design and eliminating bias over the importance of data mining. “Too much weight is given to big or diverse data. And I think that it should not simply replace properly designed studies.”
Big data in the cloud also raises security concerns, said Daniel Fabbri, Ph.D., founder and CEO of Maize Analytics, a health IT company that provides machine learning tools for hospitals to protect patient data. “As data sets are aggregated, the impact of a breach increases. Security controls need to be part of standard workflows and not an afterthought. Moreover, it is essential to have privacy processes in place to ensure that employees who have access to patient data are using that data appropriately.”
As a clinical researcher, Moons agreed. “If two tech oriented companies form a team to better evolve technology and machine learning techniques to support clinical research, [it] is good, as long as patient and clinical data remains only accessible via patients and care providers,” he said. “The medical domain is not just about commerce; it is also about privacy and ethics of very personal data.”
Regulations are evolving for cloud systems used in clinical research. This summer, the FDA released draft guidance stating sponsors are responsible for conducting “a meaningful risk assessment regarding data access, integrity and security.” In practice, regulatory agencies often rely on tech companies for cloud security controls.
“Microsoft invests more than $1 billion annually in security research to keep its cloud services and data secure for customers like Parexel. In addition, Microsoft Azure has more than 60 major compliance certifications and attestations, more than any other major public cloud provider,” Jordan said.
And the tech giant isn’t working alone. Said Jordan, “Microsoft is not only working to deliver trusted tools that life sciences companies need to grow and achieve more, but also forming deep partnerships, working side by side and learning from industry experts like Parexel. Together, with expertise from both teams, we can better identify and solve the industry’s biggest challenges.”