10 Ways Cloud Technology Is Reversing a Pharma Trend

Pharmaceutical companies manage, collaborate on, and are responsible for securely storing massive quantities of sensitive information. Consequently, while other business sectors have swarmed to take advantage of cloud computing systems’ efficiencies, the pharmaceutical industry is a relative latecomer in embracing the technology.

The industry’s steadfast resistance to the use of external networks and software-as-a-service (SaaS) solutions has been rooted in longstanding — and legitimate — concerns related to:

• Data security and integrity.
• Control over and access to data.
• Potential impact on regulatory compliance.
• Negative effects on business that might be caused by status quo disruptions or operational hiccups during migration or new system implementation.
• The time, effort and resources presumably required for a cloud migration upgrade.

As the “Top 5 Trends in the Pharmaceutical Industry in 2019” white paper clarifies, however, cloud networks provide more advantages than causes for concern in each of the areas listed above. And these upsides are now advancing the use of cloud-based systems throughout the industry and bringing the technology into the mainstream pharma world.

The white paper tells how only a decade ago, three-fourths of CIOs and IT executives of life sciences and health care companies objected to implementing cloud computing technology due to security fears.¹ But what started with modest yet verifiable cloud success stories in drug development R&D laboratories has swelled into a sea change in the wider pharma landscape. With the number of corroborative cloud case studies in all corners of the industry on the rise, pharma companies continue to grow more enthusiastic about cloud technology. In fact, 64% of life sciences companies now report that they’ve either already applied cloud structures into their environments or have plans to do so.²

How the Cloud Uniquely Benefits Pharma Companies

To understand the reasons for this reversing industry trend, one need only look at the benefits the technology provides in real-world scenarios in the life sciences. Of the many advantages gained by pharma companies that have embraced cloud technologies, the following are the top 10.

#1 - Optimized — not jeopardized — security.

As more pharma companies successfully migrate their data to the cloud, the industry is finding the notion that cloud environments are less secure than on-premise systems to be mistaken. Reputable cloud service providers offer the expertise and technology necessary to provide continuous security monitoring and incidence response, something that few pharma companies’ IT departments can manage themselves. Unlike internal IT teams that put a general security blanket across multiple applications, a cloud provider’s security experts are explicitly focused on the security of a single application. Plus, a provider can identify security issues quickly and apply patches and enhancements uniformly with automatic upgrades.

Decision-makers who have reservations about moving data offsite should consider that humans have a long history of trusting that their critical information will be secure in the hands of qualified external providers (i.e., telecoms, postal services, etc.). A qualified cloud provider with a proven track record should engender the same degree of trust. In fact, most cloud providers subject themselves to far more intensive security audits than the average pharmaceutical company can afford to do with its on-premise data center.

At their core, all cloud ventures are a partnership between a company and its cloud provider, with each side committed to prioritizing security and making the appropriate accommodations. As the Gartner Research report “Clouds Are Secure: Are You Using Them Securely?” asserts, “The most significant step an organization can take to ensure the appropriate levels of cloud security is to agree that cloud computing has become indispensable, and that it should be governed through planning and policy.”³

#2 - Faster responses to and resolution of security issues.

Cloud-based solutions counter the changing threat landscape with continual updates made by engineering teams whose sole focus is security. In on-premise environments, conversely, IT professionals are required to address each threat on an ad hoc basis. Outside of the cloud, security issues are remedied by either assigning a frantic IT team to put out the fire or hiring an external resource to come onsite to fix the problem. The cloud simplifies security issues by enabling problems to be resolved remotely and universally.

#3 - Accelerated compliance and increasingly streamlined implementations.

Compliance and the cloud are proving to have a relationship that is more symbiotic than antagonistic, as has historically been the perception. Not long ago, the concept that life sciences organizations would trust putting information in public cloud services like those offered by Google, Amazon and Microsoft seemed at odds with compliance and the critical nature of the data involved, according to Microsoft chief medical officer Simon Kos. “Microsoft coming along with a public cloud infrastructure, once upon a time, seemed like an unlikely proposition for health care, with sensitive data workloads,” Kos said. “Now we have widespread deployment of sensitive data in the public cloud in compliant ways.”⁴

There is no greater compliance concern to pharmaceutical companies that use computer systems in regulatory environments than validation. Thanks to game-changing validation optimization solutions like MasterControl’s Validation Excellence Tool (VxT) — the first automated validation tool for those doing business in regulatory environments — the time it takes a pharmaceutical company to validate an enterprise quality management system (EQMS) is decreasing appreciably. VxT clients report that they have trimmed 336 hours in overall validation project preparation time and reduced actual project execution from 104 hours of labor-intensive activities to just 20 hours.

Cloud technologies are also the perfect complement to the risk-based approach to compliance that is highly favored by regulatory agencies like the U.S. Food and Drug Administration (FDA). And, setting an example for the companies whose products it regulates, the FDA even entrusts its own information to a public cloud provider, Amazon Web Services (AWS). Like other leading regulatory bodies, the FDA also commonly promotes its own pro-cloud initiatives, as evidenced in recently departed FDA commissioner Scott Gottlieb’s appeals to developers to “find new ways to use cloud-based services and tools to support patient health and support more effective treatments, tailored to a patient’s needs and preferences.”⁵

#4 - Less reliance on in-house IT expertise and infrastructure maintenance.

Cloud service providers have the expertise and technology to provide continuous security monitoring and incident response, something that few IT departments can handle in-house. If you’re waffling on whether or not to migrate to the cloud, ask yourself: is it safer to trust your IT staff to stay current on security issues — which compounds already overburdened workloads — or count on a team of security-focused specialists that have worked within a stable cloud environment so extensively that they know exactly where to look for problems and how to rectify them?

#5 - Decreased capital investments and operational costs.

Migrating to the cloud means pharmaceutical companies can liberate themselves from continually buying or maintaining their own infrastructures, cycling through outmoded hardware and/or software systems, and constantly updating their applications. As an added business benefit, the increasing number of reliable cloud service providers — and the improved quality and breadth of the technologies they offer — are helping drive down the overall cost of cloud computing and data storage.

#6 - Seamless and automatic software updates.

Not only does an on-premise system continually depreciate and become outdated, but threats to its security inevitably increase over time — exponentially so for companies that choose to be “version sitters” that don’t regularly upgrade to a software application’s most recent release. The central management and distribution of software updates via the cloud ensures that pharma companies can take advantage of more new features sooner in cloud environments while also eliminating the headaches of declining computer systems.

#7 - Unprecedented access to and control over data.

Cloud technologies streamline pharma companies’ capacity to share information across multiple geographies and collaborate with authorized external parties like vendors and contract research organizations (CROs). More importantly, SaaS providers have contractual agreements and security controls built into their systems to guarantee that only your company’s authorized users have access to the company’s data and that the data actually belongs to you, as established in the MasterControl white paper “The Business Case for Moving to the Cloud.”

Any reputable cloud system’s design will be specifically geared toward security assurance and authorized access, with the latest security measures (i.e., encryption, multi-factor authentication, etc.) built in. Before selecting a cloud provider, review their certifications and audits against industry standards to ensure that the service meets the needs for data security, access and control that pharmaceutical organizations require.

#8 - The virtualization of research.

The cloud offers the capability to connect all the various parties involved with research data systems and enables them to collaborate in formerly unimaginable ways. These functionalities are a tremendous boon to drug researchers and hint at the cloud’s potential to revolutionize clinical trials.

Most of the tried-and-true research processes currently applied to clinical trials have been applied as far back as the 1940s. With the advanced data analytics capabilities provided by modern digital solutions, there’s no limit to the emerging number of novel approaches to clinical research. The enhanced ability to digitally track biomarkers and vital signs in an unobtrusive and continuous manner — recently labeled as “continuomics” — is bringing entirely virtual clinical trials closer to the mainstream.⁶ Researchers now have access to tools that enable them to more precisely and expediently track crucial trial variables such as adverse reactions to drug therapies and adherence to study protocols.

In an early demonstration of the cloud’s promising future in virtualized research, the clinical research company Science 37 recently conducted an entirely virtual Phase 2B placebo-controlled trial. The virtual trial to test a topical acne formulation resulted in the successful screening of more than 8,000 individuals and the enrollment of 372 participants. Science 37 reported that conducting the trial virtually allowed researchers to reduce projected enrollment times by 30-50%, an encouraging portent of cloud-facilitated research advancements yet to come.⁷

#9 - Agility and scalability.

Pharma companies’ processes are complex and data intensive. And, as the speed at which data can be accessed, interpreted and utilized increasingly becomes a differentiator in the industry, companies need cutting-edge tools to stay competitive. The cloud provides the capacity pharma companies need to handle diverse sets of data types at the requisite scale and facilitates the development of more coherent datasets.

In an industry where continual changes and innovations to products, regulations and markets are the norm, one of cloud technology’s most appealing aspects is its ability to scale up or down according to pharma companies’ usage needs. 3M Health Information Systems is one example of a life sciences company that addressed the challenges of ebbing and flowing workloads by migrating some of its applications to the AWS cloud. The company’s move to the cloud has increased its agility — cutting a 10-week server-provisioning process down to minutes — as well as its speed in developing and deploying new applications. “We are getting out of IT operations, to allow us to focus our R&D team on the science of health care,” said 3M HIS chief technology officer David Frazee. “For us that means analytics rather than IT, enabling us to attack the health care industry’s cost and quality challenges.”⁸

#10 - A leveling of the pharma industry playing field.

In an increasing number of instances, the cloud is empowering small pharmaceutical companies with shoestring budgets to affordably leverage the same or comparable robust tools used by wealthy multinational corporations. A proven platform allows a company of any size to reap the cloud’s benefits, according to Deloitte Risk and Financial Advisory principal Kieran Norton. “If you've invested $1 billion in your cybersecurity program, you probably have a pretty secure network. But if you don't have that kind of money, there are cloud providers who can dump more resources, technology and R&D into building that base infrastructure,” Norton said.⁹

Learn more about the impact cloud technology is having on the pharmaceutical industry and discover other issues influencing the future of pharma in the “Top 5 Trends in the Pharmaceutical Industry in 2019” white paper from MasterControl.

References

1. “Adopting cloud computing within the healthcare industry: opportunity or risk?” by Linda Barthelus, Online Journal of Applied Knowledge Management, Vol. 4, Issue 1, 2016.
2. “Digitalization in life sciences,” KPMG, January 2018.
3. “Clouds Are Secure: Are You Using Them Securely?” Gartner Research, Jay Heiser, Analyst, Sept. 22, 2015.
4. “Why healthcare data may be more secure with cloud computing,” by Jonah Comstock, MobiHealthNews, Oct. 15, 2018.
5. “Transforming FDA’s Approach to Digital Health,” Scott Gottlieb, M.D., Academy Health’s 2018 Health Datapalooza, April 26, 2018 (remarks as prepared for delivery).
6. “The Future of Drug Trials Is Better Data and Continuous Monitoring,” by A. Fantana, G. Cella, C. Benson and J. Kvedar, Harvard Business Review, May 2, 2019.
7. “Digital R&D: Transforming the future of clinical development,” by Dawn Anderson, Natasha Elsner and Jonathan Fox, Deloitte Insights, Feb. 14, 2018.
8. 3M Health Information Systems case study, AWS.
9. “Debunking cloud security myths: truth vs. fiction,” Architecting the Cloud, On Cloud podcast, May 1, 2019.