As I have shared within other posts within this series, businesses are using analytics to improve their internal and external facing business processes and to strengthen their “right to win” within the markets that they operate. For pharmaceutical businesses, strengthening the right to win begins and ends with the drug product development lifecycle. I remember, for example, talking several years ago to the CFO of major pharmaceutical company and having him tell me the most important financial metrics for him had to do with reducing the time to market for a new drug and maximizing the period of patent protection. Clearly, the faster a pharmaceutical company gets a product to market, the faster it can begin to earning a return on its investment.
Fragmented data challenged analytical efforts
At Quintiles, what the business needed was a system with the ability to optimize design, execution, quality, and management of clinical trials. Management’s goal was to dramatically shorten time to complete each trial, including quickly identifying when a trial should be terminated. At the same time, management wanted to continuously comply with regulatory scrutiny from Federal Drug Administration and use it to proactively monitor and manage notable trial events.
The problem was Quintiles data was fragmented across multiple systems and this delayed the ability to make business decisions. Like many organizations, Quintiles data was located in multiple incompatible legacy systems. This meant there was extensive manual data manipulation before data could become useful. As well, incompatible legacy systems impeded data integration and normalization, and prohibited a holistic view across all sources. Making matters worse, management felt that it lacked the ability to take corrective actions in a timely manner.
Infosario launched to manage Quintiles analytical challenges
To address these challenges, Quintiles leadership launched the Infosario Clinical Data Management Platform to power its pharmaceutical product development process. Infosario breaks down the silos of information that have limited combining massive quantities of scientific and operational data collected during clinical development with tens of millions of real-world patient records and population data. This step empowered researchers and drug developers to unlock a holistic view of data. This improved decision-making, and ultimately increasing the probability of success at every step in a product’s lifecycle. Quintiles Chief Information Officer, Richard Thomas says, “The drug development process is predicated upon the availability of high quality data with which to collaborate and make informed decisions during the evolution of a product or treatment”.
What Quintiles has succeeded in doing with Infosario is the integration of data and processes associated with a drug’s lifecycle. This includes creating a data engine to collect, clean, and prepare data for analysis. The data is then combined with clinical research data and information from other sources to provide a set of predictive analytics. This of course is aimed at impacting business outcomes.
The Infosario solution consists of several core elements
At its core, Infosario provides the data integration and data quality capabilities for extracting and organizing clinical and operational data. The approach combines and harmonizes data from multiple heterogeneous sources into what is called the Infosario Data Factory repository. The end is to accelerate reporting. Infosario leverages data federation /virtualization technologies to acquire information from disparate sources in a timely manner without affecting the underlying foundational enterprise data warehouse. As well, it implements a rule-based, real-time intelligent monitoring and alerting to enable the business to tweak and enhance business processes as they are needed. A “monitoring and alerting layer” sits on top of the data, with the facility to rapidly provide intelligent alerts to appropriate stakeholders regarding trial-related issues and milestone events. Here are some more specifics on the components of the Infosario solution:
• Data Mastering provides the capability to link multi-domains of data. This enables enterprise information assets to be actively managed, with an integrated view of the hierarchies and relationships.
• Data Management provides the high performance, scalable data integration needed to support enterprise data warehouses and critical operational data stores.
• Data Services provides the ability to combine data from multiple heterogeneous data sources into a single virtualized view. This allows Infosario to utilize data services to accelerate delivery of needed information.
• Complex Event Processing manages the critical task of monitoring enterprise data quality events and delivering alerts to key stakeholders to take necessary action.
According to Richard Thomas, “the drug development process rests on the high quality data being used to make informed decisions during the evolution of a product or treatment. Quintiles’ Infosario clinical data management platform gives researchers and drug developers with the knowledge needed to improve decision-making and ultimately increase the probability of success at every step in a product’s lifecycle.” This it enables enhanced data accuracy, timeliness, and completeness. On the business side, it has enables Quintiles to establish industry-leading information and insight. And this in turn has enables the ability to make faster, more informed decisions, and to take action based on insights. This importantly has led to a faster time to market and a lengthening of the period of patent protection.