Using Data Lakes to Leverage the Growing Complexity of Clinical Trials

“In recent years, the volume and complexity of data generated by clinical trials have exploded. This is due to a number of factors, including the increasing use of electronic medical records, the development of wearable devices, and the growth of patient-generated data.”[1]

Clinical trials are a critical part of any pharmaceutical company’s business, and over the past decade, the industry investment in clinical trials has grown 10-fold.[2] To support a greater volume of research, companies are involving more external partners who, along with a myriad of internal sources, are creating data in greater volumes than ever before. In addition to the impact this vast amount of data can have on managing quality control, regulatory compliance, and intellectual property, it makes it more difficult to access the right data and the right levels of data to make strategic decisions; and in this rapidly expanding and changing research landscape, swift decision-making and adaptation could be the difference between profitable and not.

Our client, a global Japanese pharmaceutical company with a presence in 29 countries and regions, experienced a rapid expansion and diversification of its portfolio. The number of active clinical studies increased 56% globally over 4 years, and they forecasted FTEs for the next 5 years to increase by 70% in the US/EU and 50% in Japan. Recognizing the impact this growth would have on their organization, they launched a Global R&D Excellence reporting initiative, and they partnered with Virtua Pharma Technology to identify and implement tools and strategies that would enable them to respond to the expected growth and even position them for the future.

To understand the scope of the program: the client managed their research and development from 18 locations in 10 countries. Data was siloed within external partners as well as local data warehouses, stored in different formats, and accessible regionally. This fragmentation of information made it nearly impossible to get one, global picture of their portfolio. They wanted the capability to see, analyze, and evaluate the most recent information to make data-driven decisions in near-real time.

To meet this need, Virtua Pharma Technology helped them implement a Data Lake*: one global repository where raw data from CROs, vendors, and various parts of the business (quality management, drug discovery, clinical trials, etc.) could be collected and stored. This made it possible to access all of the volumes of global source data, but to take advantage of all of that complex information required additional tools.

Virtua Pharma Technology worked with the client to design and develop custom dashboards that accessed, analyzed, and presented near-real time information to enable data-driven decision-making in their studies across the globe. Early trend and risk detection allowed for earlier mitigation and increased patient safety, quality, and performance. Additionally, with timely access to CRO data, they were able to better manage studies, improve forecasting, reduce costs, and enhance planning capabilities.

“Because of [Virtua’s] support and attention to detail (which is exemplary) [the company] will benefit as the [the system] is rolled out and evolves to add value to the business.” (Manager, R&D Excellence)

As the Excellence program progresses, Virtua Pharma Technology continues to look for new ways to help their client leverage these new tools and evolve as the industry begins to look at AI, machine learning, and other new technologies that will impact R&D and clinical trials.

*Data Lake: a large, highly scalable storage repository with diverse structured and unstructured data from various sources.

[1] The Power of Data-Driven Decision-Making in Clinical Research: From Insights to Innovation | CRO | Medical Devices | Pharmaceutical | Biotechnology, NoyMed CRO

[2] Research and Development in the Pharmaceutical Industry, Congressional Budget Office