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Regulation, compliance and governance: cloud migration in the pharmaceutical sector

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Regulated sectors, such as pharmaceuticals or the financial services industry, often have a reputation for being slow-moving or less innovative than some other industries. There is good reason for this. They are constrained by regulatory requirements and slow and cautious will often win over fast and furious.

I’m conscious that as part of a technology ecosystem, SAS can be a long way from our end-users and can sometimes have challenges understanding all our customers drivers. It is therefore good to be able to rely on and have regular conversations with partners that are daily working on customers projects and systems. Ian Amaranayake is Delivery Director at Katalyze Data, a SAS partner and advanced analytics company. Katalyze Data provides professional services, SAS software and SAS support across the life sciences, financial services, retail and public sector, mostly in the UK and Ireland. The company aims to help its customers to get the best possible return on their investment in SAS software, with a strong focus on innovation and best practice.

 

Building on standards

In the pharmaceutical sector, Katalyze Data focuses mainly on R&D and clinical trials, assisted by the number of its senior staff with experience in the industry and a track record of supporting life sciences clients over many years. SAS has traditionally been widely used in this sector, because it supports regulatory requirements. However, Ian has noticed a change emerging.

“We now work in a much more competitive analytics market. Within the pharmaceutical industry, there’s a real drive towards open source technologies, but that has to be balanced with the challenges around the need for robust validation practices. With SAS, there are tried and tested approaches and policies and procedures in place that have enabled organisations to manage their workloads. In comparison, the industry is at the start of the learning curve with the wide-scale adoption of open source technologies for regulatory submissions.”

 

He adds that this should not be seen as a threat.

“I think it’s a good thing that they’re broadening their horizons. I don’t see it as a threat to SAS, especially because SAS Viya is designed to work with open source, and supports users in their use of SAS, R and Python. However, it does change how we work with clients to help them get the best out of their existing investment in analytics. We’re far more actively engaged with providing open source support for customers in conjunction with SAS than we have been previously.”

Ian believes that a service offering is key to position Viya in the marketplace.

“Viya’s going to be attractive, especially as companies start to move into the cloud. But the software won’t sell itself, and that’s why we provide consultancy services to help our customers understand the benefits and support their change initiatives as they look to modernise their Statistical Computing Environments. A lot of that is about education and training, but we also help ensure that there’s ongoing support and compliance for their systems.”

 

Cloud migration vs. digital transformation

We often find that customers talk about ‘digital transformation’ when what is actually happening is a migration to cloud. Is this just a first step, or is that the only purpose? Ian has a view on this.

“ The pattern I see most often is that organisations want to take the risk out of modernisation, and so they do a ‘lift and shift’. They might do a bit of housekeeping, but fundamentally, they’re moving their workflows and content from A to B, from on premise to the cloud.

Ian believes this is a reasonable starting point, but companies often need more support to go that step further.

 

“A common mistake some organisations make is to treat a move to Viya as an upgrade, rather than a digital cloud transformation project. It's not just about re-platforming. To get the full benefits, you have to put the right governance and validation in place. It’s also an ideal opportunity to refactor your processes, to take advantage of the powerful new tools and capabilities available in Viya—but this needs to be done in a measured way. Lift and shift is a good place to start, but it’s equally important to not ‘set and forget’. There are also key considerations around performance, security, and sustainability when you move to cloud which need to be thought through and planned.”

 

The importance of trust

Circling back to earlier in our conversation, Ian suggests that the most important factor is building and maintaining trusted relationships with our pharmaceutical colleagues.

 

“It is incredibly important for organisations embarking on a modernisation to Viya to have a company-wide cloud strategy in order to fully grasp the opportunities both Viya and the cloud provides. Viya has strong capabilities in model-building and visualisation. We also know that there are new generative AI capabilities, for example in synthetic data generation and SAS co-pilot which are on SAS’s roadmap. However, learning to use these effectively won’t happen overnight. It’s an ongoing process, and both we and our customers are in it together for the long haul. It’s all about building successful trusted relationships—on both sides.”

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