Top 10 Pharma.

Statistical Computing Environment

Case study

At a glance

We are working on a multi-year project to design and build a Statistical Computing Environment (SCE) for one of the Top 5 pharmaceutical companies worldwide. The project is accelerating clinical trials for life-saving drugs and vaccines.

SCE systems manage the versioning, security, and integrity of data, programs, and outputs used in clinical data analysis. An SCE streamlines operations and helps pharmaceutical companies comply with the regulations of the US FDA (21 CFR Part 11) and the European Medicines Agency.

Client

Top 10 Pharma

Sector

Health & Life Sciences

Project

Statistical Computing Environment

Activities

Stakeholder interviews

User interviews

Design Thinking workshops

Personas

User journeys

Functional & technical workshops

Clickable prototype

Usability testing (multiple rounds)

Graphic design

Design system

Cloud & systems architecture

Development in Agile sprints

Quality testing, including UXQA

Technologies

AWS Cloud

Single Sign On

Microservices Architecture

Lustre File System

Autoscaling Kubernetes Containers

Java backend

React/Redux frontend

SAS Grid

SAS Studio

R Cluster

R Studio

Modernizing clinical data analytics for R&D

Our client's legacy system was reaching its "end of life" and needed to be redesigned to suit new ways of working and new technologies such as cloud computing and open-source statistical programming languages like R. The company was keen to ensure that the new system met modern-day standards of performance, modularity, and usability.

Whitespace joined clinical analytics specialists from d-wise to design and build a world-class enterprise solution in record time, compared to similar efforts ongoing at other Pharma companies.

Interactive prototype
Interactive prototype
Ideation workshop
Ideation workshop

User-centered design for a successful outcome

Whitespace guided the client stakeholders and internationally distributed development teams through a complete user-centered design approach.

We led multiple UX workshops in the USA and Europe, as well as conducted interviews with statisticians, medical writers, data analysts, and statistical programmers in North America, Europe, and Asia.

Using the insights obtained from the UX research phase, we recommended a new optimized workflow and user interface design for a cloud-based statistical analysis & reporting solution that we then tested with real users from the client's globally distributed team.

The custom build is based on a React/Redux front-end, a Java back-end, and SAS/R grids deployed on Amazon EKS.

30-person delivery team, of which Whitespace was (and still is) an integral part, collaborated across 9 countries and multiple time zones to deliver this project on time and on budget. The project continues to this day as enhancements are added in an iterative, user-centered approach.

astronauts-exchanging-files
Animations in the system make large and lengthy file transfers more fun.

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We really enjoyed working with you and everyone from Whitespace. Your experience, knowledge, and professionalism were truly something we needed on the project to make it a success. And your self-motivation, enthusiasm, dedication, and diligence are a true inspiration! Big kudos to all of you and a big thank you for everything.

Director, Scientific Computing Operations, Statistics & Decisions Sciences

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What success looks like

Today, our client's bespoke SCE solution is used by over 800 statistical programmers and clinical data analytics professionals worldwide to accelerate the delivery of new medicines and vaccines to market.

The new product is widely considered to be one of the leading SCE platforms currently in use in the pharmaceutical industry and is the envy of the company's peers. The combination of a scalable cloud computing architecture with a modern user interface, clear workflows, robust audit trail, and an open-source programming environment is leading to dramatic efficiency gains at the company.

happy demo scene

800+

Members of R&D impacted

2x

Development timeframe

50%

Lower cost than alternative systems

1.5x

Faster time to market for drugs

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Julia Borkenhagen

Julia Borkenhagen

Chief Experience Officer

It's not easy to understand the complexities of the clinical trial process, much less the nuances of data analytics within the biostats function of a very large pharmaceutical company. We learned so much during this project and it has enabled us to expand our UX, business analysis, and software development practices into the clinical space.

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