Cloud Hosting Legacy System Modernization Computer System Validation Acceleration Services Data Accessibility

Engineering Together- How Sponsors are Reinventing the SCE by Working Together

Cloud Hosting Legacy System Modernization Computer System Validation Acceleration Services Data Accessibility

We are approaching a tipping point in how technology is used in clinical trial analytics.

Based on our experience through partnerships and research with many of the industry leaders,  the days of having only two options: independently buying and then integrating a product (i.e. Sycamore, EntimICE or LSAF), OR alternatively building your own custom solution, are about to change. Cross-industry requirements for a flexible, cloud and language agnostic SCE have been drafted and will be discussed at PHUSE EU Connect 2020, November 10th  at 1:00 pm GMT.

In the twenty years d-wise has advised and provided services around Statistical Computing Environments (SCEs), we have identified a trend in modernization occurring at most global pharmaceutical companies. Using our proprietary consulting tool, Market Monitor, our team has been recording and measuring the evolution of clinical technology to better be able to serve and understand our industry. This has revealed that most companies have followed an independent modernization cycle to either significantly integrate or custom build their own proprietary solutions about every five to ten years. Some of the leaders at these companies have collaborated to identify their requirements with one important insight being that the clinical data should be the source for competitive advantage, not the technology of the SCE itself.

It is amazing that as little as five years ago, few could have imaged that pharma sponsors would be doing something as brazen and daring as moving their clinical data onto the cloud. This is becoming the norm with many companies moving to a cloud-based infrastructure. In fact, d-wise is working with one of the largest pharma companies through our Acceleration Services to engineer a solution for analyzing their clinical data in a compliant workflow managed by technology. Read Case Study

open framework iceberg

d-wise is seeing something happen that is unprecedented; the community is collaborating together and seeking a third option when faced with a buy or build decision for their SCE. This third option is being driven by the disruption of episodic modernizations, the inability to rapidly adopt open source technologies, and sponsor IT teams struggling to support a highly customized environment.

Industry is asking for this third option to be scalable, highly flexible and fit for the regulated environment we exist in. A foundation for radical automation which aspires to deliver agility in exploration and rigour in delivery to enable teams to transform data into action for the good of human health.

The pathway ahead will be a collective effort by sponsors, vendors, consultants, and cloud providers. Please join us as we discuss what we believe to be a tipping point on November 10th at 1pm GMT. At this workshop we will review the PHUSE paper authored by leaders at Bayer, Boehringer Ingelheim, GSK, Janssen, Novartis and Roche, which describes foundational requirements of a modern statistical computing environment. The workshop will consist of an exciting mix of informative and thought-provoking presentations, and break-out sessions around requirement categories (Infrastructure, Automation, Validation and QC, Identification of other requirements) with a goal to have common SCE requirements for our community to engineer together in 2021.

Please join our community as together we aspire to create a third option for SCE modernization built around the sponsors’ list of shared requirements. Learn more and register here.