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SAS® enables pharmaceutical giant to harness clinical data amassed over 20 years

When this multinational needed to consolidate and harmonise clinical trials data to meet regulatory demands and enable added value analytics, SAS® Professional Services' innovative approach improved speed and reliability while reducing costs.

As you would expect, 12,000-plus clinical studies over two decades generate huge volumes of data. However, US Food and Drug Administration (FDA) regulations require drug companies to be able to provide, within hours, data relating to a specific study to prove it matches data contained in the regulatory submission. In this case, the company found it increasingly hard to meet these demands. With trials conducted worldwide and by various companies acquired over the years, data was in many different systems and formats in different countries, while data standards and naming conventions had evolved and changed. Moreover, the company recognised that with all this data in an easily accessible and usable form, the resulting repository could also support added-value analytics: for example, clinical trials simulations to improve future activity. "If you can run simulations then decide not to use a particular design because it has a low chance of success, you've potentially saved your company 10-40 million dollars – because inconclusive trials are a complete waste of money," says Dave Smith, Solution Architect, SAS UK.

To consolidate and harmonise all this data, the company engaged SAS® Professional Services along with an outsourcing provider tasked with running the programme and providing data managers. "Our job is to provide specific expertise as part of a threecompany consortium," explains Dave Annis, Head of Managed Services, SAS UK. SAS was involved from the outset, and made a significant contribution to the overall design of the three-year programme, which spans multiple locations across three continents and is set for completion in 2013.

Thinking differently – delivering more

SAS had to not only find a way to consolidate and harmonise data that varied in age by 20 years, during which time relevant data standards had changed massively, but the processes had to be transparent and fully auditable. "That's a key reason why we used SAS® for Clinical Data Integration and SAS® Drug Development, because SAS provides that full audit trail," Annis says. "But this goes far beyond software: when customers invest in our services what they are buying is exceptional people. And because we're the software provider, they know they'll benefit from the highest possible level of commitment to the success of the project." As Solution Architect, Dave Smith's role was to turn client requirements "into a software stack and a sizing for the infrastructure: delivering the entire solution including hardware, and standing by our design."

Dave Smith's key contribution was an innovative solution design that combined a SAS Drug Development repository with SAS for Clinical Data Integration capabilities and what he calls "the cunning use of DataFlux® technology to analyse clinical studies metadata and increase the speed at which they could be put into the right places, to really understand the meaning of variable names. What I brought to the table was deep technical knowledge of SAS plus huge experience working in and for the pharmaceutical industry. I understood what they wanted to do, including the huge scale of the task, and could map the right products onto that. Throwing bodies at a problem like this is simply not enough. If you have thousands of studies, each with 100 data sets, each with 25 variables, you'll soon have tens of millions of columns. Each variable has to be interpreted to make it useful."

Annis adds, "Dave Smith came up with the smart idea of using SAS data quality capabilities not for the content of the data but, to start with, just the names. This meant you could start creating groups of columns and variables and tables likely to mean the same thing – speeding the whole process up. Otherwise, we'd estimated it would take two-and-a-half person-years just to read the data. So we worked with our client and the outsourcing partner's Life Sciences team to do something completely new with the software; nobody had attempted this kind of project before. It was a stroke of genius."

Massive data moves to SAS hosting facility

The solution now manages the entire harmonisation process, with a team of medics advising on naming conventions. 100-plus data managers use SAS at the outsourcer's facilities in India, with SAS providing training along with software configuration and installation. Crucially, SAS is also delivering the software element as part of its SAS® Solutions OnDemand offering, and physically hosts the data repository at its headquarters in Cary, North Carolina. Users locate the data they need from wherever in the world it resides then copy it to Cary, using SAS to prove it's moved in the right way and for an audit trail. Each year will see multiple terabytes of data moved.

"We'd set expectations around time frames and deliverables," says Will Adkins, the SAS Program Manager responsible for delivery of the working system. This involved managing numerous teams and stakeholders across multiple time zones. "A big issue was aggressive timelines set by the client that didn't seem to allow for enough time to complete tasks essential for a validated installation: you have to follow a particular process to ensure regulatory compliance. As a result, I had to coordinate very closely with multiple teams to develop an effective approach that not only met programme goals but also had the least impact on timelines." The outsourcer had only limited experience with validated installations, "So we provided the expertise necessary to ensure compliance." Following deployment, the client conducted a three-day audit of SAS processes, procedures and staff: "This confirmed the high quality of our work and conformance to standards," Will says. "Throughout, they really appreciated our guidance and believed the project could have failed without it. Since the whole company depends on clinical trials and drug development, this project could not be allowed to fail without risk to the entire business."

With data movements and transformations under way, the solution has been tested, the installation validated and work continues, with SAS Professional Services providing ad hoc advice and support as required. "Given its global nature, this programme's a 24/7 operation, so Professional Services has to be ready to respond to any problems around-the-clock," Dave Annis adds. "When issues come up, we deal with them. In part, this is about assuming responsibility for key areas – and reducing risk wherever possible."

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Pharmaceuticals Company

Business Issue:
Requirement to harmonise massive volumes of data in the fastest, most accurate and cost-effective way to meet regulatory demands and provide a rich resource for added value analytics.
Solution:
A blended team combining: domain knowledge, technical expertise, the power of SAS® software, hosting services, global co-ordination, education – and a genuinely novel application of SAS technology.
Benefits:
End-to-end support that speeded up the process: helping the company better address regulatory demands and so avoid penalties; potential new insights for clinical trials simulations that could save the business tens of millions of dollars.

If you can run simulations then decide not to use a particular design because it has a low chance of success, you've potentially saved your company 10-40 million dollars – because inconclusive trials are a complete waste of money.

Dave Smith

Solution Architect, SAS UK

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