Life sciences businesses need to gather vast amounts of data – and quickly. One pressing reason for this is the looming Identification of Medicinal Products (IDMP), which places increased pressure on companies to find more practical and flexible next generation solutions to manage their IT infrastructure.
By Dawn Waite, Manager, Life Sciences Cloud Solutions
Recognition and response to this need has been mixed. Some companies are starting to assess next generation solutions in terms of how these could address their regulatory and business needs in an increasingly digital ecosystem. But many aren’t. While IDMP is at the heart of many business conversations about their IT solutions, the simple fact is that a large percentage of companies just don’t have systems capable of responding to this complex requirement. Furthermore, adding more systems internally to address IDMP in the timescales required – at least for Europe – is going to be a challenge, not to mention costly. There is also the complex issue of having to update systems and processes to ensure compliance and control. Given the close scrutiny life sciences companies are subject to and the audits they must prepare for, managing validation for additional internal systems will only increase business and technology burdens.
The answer, as many companies are starting to understand, lies in the cloud. But a question we often hear is, won’t this simply be an additional burden to my existing on-premise solutions?
For example, we spoke recently with a business leader at one pharma company with a very large on-premise solution. The company has a large technical and support team that run the solution today. In our conversations, what we learned is that the manager tasked with finding a solution believed that many of those individuals would have to be retained in their current roles to continue to manage the solution even if the company transitioned to the cloud.
That’s simply not true, because all those day-to-day operations required to run the solution would be removed.
How does this work?
When a company moves to a cloud solution all the activities that were once needed to keep the infrastructure up to date, e.g., the constant server and OS upgrades, the day-to-day management, are removed because the cloud vendor keeps systems evergreen. The term evergreen in IT describes both services and infrastructure that are continuously kept up to date.
By removing those day-to-day demands, companies can either cut costs by reducing the workforce, or perhaps take advantage of that in-house expertise and move those people to more complex IT projects that have lain dormant because there just wasn’t the bandwidth to tackle them. Realigning resources allows the company to get the best out of the system. Where companies elect to have their own cloud platform, having expert support to manage that solution removes many of the validation burdens they might otherwise face.
Cloud vs. on-premise
A problem that many life sciences companies have struggled with is keeping systems in line with changing industry and regulatory developments. Let’s return to the example of IDMP. Right now the focus is on what’s happening with the European Medicines Agency (EMA), but in time companies will also have to prepare for IDMP requirements from the U.S. Food and Drug Administration (FDA) and, ultimately from regulators globally. Therefore, the systems that handle those IDMP requirements will have to change in line with those developments. How does a company do that on premise without having a large technical workforce to support those changes?
Pushing the IT services and infrastructure to a vendor not only keeps the systems evergreen, but also removes many of the operational costs that flow from managing IT internally. For example, as servers age, companies either have to upgrade them with additional compute capabilities or replace the hardware. These activities bring both cost and complexity since that hardware has to be validated to ensure that it’s compliant with strict regulatory requirements.
If a vendor is managing the infrastructure in the cloud, their clients never have to go through the hardware refresh again. Nor do they have to pay for maintenance contracts and the ongoing licenses for additional software, such as SQL or SharePoint, since this becomes the responsibility of the vendor (at least in the case of large vendors) who purchases the licenses and allows their clients to leverage that buying power.
The cost of retaining IT infrastructure and the required upgrades and licenses is significant. One company we spoke with assigns around $500,000 every 3 years or so simply to handle infrastructure upgrades. Removing that cost allows money to be invested elsewhere, which in turn means the company can concentrate on the business of bringing products to the market and strengthening business innovation.
Shifting the focus away from day-to-day IT operations and the costs that go with it, and toward an overall solution that serves the broader needs of the organization is a clear long-term win for the business.
If you are attending the CSC Client Conference in Orlando, Florida, from September 18 to 22, please join the Life Sciences presentation, The Regulatory Cloud and aaS Model, on Tuesday 20 September.