Drug failures account for a substantial proportion of research and development costs and result from a variety of risk factors, most of which relate to concerns about drug safety and drug efficacy

When drugs fail because of these safety concerns, time costs become another factor as a tremendous amount of resource expenditures are lost forever. To remedy costs associated with drug failure, pharmaceutical companies have long explored ways to reduce phase lengths through more efficient approaches to R&D.

When the client, a multinational pharmaceutical and biologics company, approached EPAM, the company was looking to develop and implement innovative analytical technology solutions to enable scientists to interrogate trail data and make data-driven, scientific decisions earlier in the process. As a result of its positive impact on process effectiveness and data availability, the solution won the client’s internal CIO Excellence Award and Innovative Medicine Award as well as the external BioIT World 2014 Award.

Key Challenges

• Limited static reports that lack the necessary flexibility to easily answer specific data queries
• Manual analyses by taking paper-based static reports and reproducing data values in tools in Microsoft Excel and Microsoft PowerPoint
• Inability to pull reports upon request, inhibiting decision-making processes

Solution Highlights

The EPAM team designed and implemented an adaptable, flexible ETL solution that delivers the core functionality requested by the client, working to Extract, Transform, and Load data from source files every 24 hours. The solution works by extracting the data from the source SAS files and then transforming it into objects within an Oracle database. From there, the data is loaded and analyzed via Spotfire, a data visualization and analytics software. As a platform, the Clinical Data Pulling Solution offers other innovative features such as:

• Ability to monitor drug safety, tolerability, efficacy, and clinical study protocol deviations in Spotfire analyses via developed templates each with a set of visualizations tailored to provide insight into one of four areas
• Up-to-date clinical trials information available for analysis via Spotfire
• Template-based approach for Spotfire views, management of Spotfire views, and propagation across multiple studies with the help of custom Spotfire Automation services created using Spotfire SDK
• Consistent look and feel of pages regardless of visualization type
• Ability to create customized visualizations (e.g. JavaScript-based) via the additional abstraction layer in the database that bears the visualization logic
• Automated data processing allowing the study team to focus on data analysis
• Configuration to support new sources of data, new formats of input data, and new types of visualizations (Spotfire and JavaScript-based)

The Results

EPAM’s Clinical Data Pulling Solution constitutes a step forward in the real-time investigation of clinical trials data and represents a measured improvement on the previous system, which consisted in large part of examining data that had been validated through manual processes. Upon implementation, EPAM’s solution enabled the client to achieve the following objectives in clinical trials:

• Improve safety monitoring and support operational decision-making
• Provide an intuitive, powerful, and flexible tool for study teams to interrogate clinical study data from ongoing clinical trials within phases I and II
• Gain insight into areas of drug safety, drug tolerability, and treatment efficacy, as well as into the capture of clinical data
• Introduce best-practice reporting procedures that ensure the integrity of clinical trial data as well as the privacy of trial subjects
• Automate and standardize workflow to achieve cost-effective resourcing and decrease the costs of drug failure
• Increase drug safety and ethicality for patients by ruling out drugs that are not effective and/or have significant adverse effects

As a result of its positive impact on process effectiveness and data availability for the client, the solution won the client’s internal CIO Excellence Award and Innovative Medicine Award as well as the external BioIT World 2014 Award.

Technologies Used