Benefits outweigh thecomplexities, challenges of finding right vendorsBy Ronald RosenbergCenterWatch Staff Writer

Mention cloud computing for clinical trials and you’re likely to hear how it has begun to lower skyrocket-

ing R&D costs while providing ease of use, rapid scalability, flexibility and availability when compared to other storage and pro-cessing options.

Having the latest and most reliable in-formation readily available coupled with the ability to share it in real time and run the same program across multiple dispa-rate computers in different parts of the world is just the beginning. The ability to analyze results more quickly and commu-nicate with clinical research teams across the globe—plus store it all virtually—are among its major benefits for large sponsors and CROs. Customers can draw as much or as little computing power they need.

The “cloud” or “cloud systems” are terms used to describe a virtual program that stores information and allows a network of computers—either publicly or with limited access—to connect and share files via the

internet. All data is kept in a virtual space or “in the cloud” rather than a single stor-age system. This enables virtually unlim-ited computing resources on tap, which allows pharmaceutical researchers to scale their computing environment up or down when they need it. It also makes it easier for companies to adapt solutions to their spe-cific needs.

It’s why the cloud has been described as an automated, elastic and cost-efficient en-vironment that costs less than creating an on-premise data center.

And the concerns over privacy and se-curity that were a major issue five years ago have waned, as users have gained confidence to trust and place their data in the cloud.

“It’s not a fear of putting data in the cloud, but rather a use case of having the comfort of wanting tools and technologies for analytics separate from the cloud,” said Steve Rosenberg, senior vice president and general manager of Oracle’s Health Scienc-es business unit.

For small companies, the same cloud computing services provide a fast way to launch a new product and still focus on developing product features instead of fine-tuning office servers.

And it’s easier for smaller sponsors, running relatively few studies at one time, to move to the cloud than for a larger sponsor with on-premise applications with hundreds of studies and thousands of users to consider during the migration process.

“The delivery of cloud computing is no longer a ‘future concept’—it’s here! And many companies see it as their preferred option to provision technology within the organization,” said Rob Petrie, vice president, information technology at PPD.

Cloud computing expanding into all areas of clinical trial conduct

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Top cloud computing pain points for managers

N=800 Source: EMC 2013

79%Managing storage growth

46%Designing, deploying and managingbackup and recovery

39%Making informed, strategic decisions

38%Designing, deploying and managingdisaster recovery solutions

37%Designing, deploying andmanaging server environments

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“There is no doubt there will be continued adoption of cloud computing to support the process of delivering a clinical trial. How-ever, the greatest potential impact will be cloud computing that supports warehous-ing of clinical trial data to help retain and analyze that data during the clinical trial process and assist in the submission to the FDA. Cloud computing is not going to de-liver innovation and process optimization. One could argue that cloud technology is best suited to back office and administra-tive activities, where a ‘standardized best practice’ exists. If a company wants to dif-ferentiate through technology, this is some-thing they would deliver internally to their customers.”

Still others maintain cloud computing is simply an extension of what began in the late 1990s as ways to use applications best suited for the web that were in corporate data centers or on office desktop computers. These computer companies were “applica-tion service providers,” delivering scientific computing for companies not interested in building a data center as client-server computing and centralized management of technology were evolving.

“We hosted those applications and that is what we now call cloud computing—the early version,” said Glen DeVries, co-found-er and president of Medidata Solutions. “It was us managing the environment, the servers, the data capture and all the analyt-

ics. So when people get excited about the phrase ‘cloud computing’ we’ve been work-ing that model for a long time—15 years.”

Fast forward to 2014 and cloud comput-ing seems to be everywhere in the clinical research enterprise, providing the ability to access value-added services from any place at any time, with a level of simplicity and cost efficiency.

A recent study by Transparency Market Research showed the global cloud comput-ing market in the healthcare industry has climbed from $1.82 billion in 2011 and is ex-pected to reach $6.79 billion in 2018, grow-ing at a CAGR of 20.9%. And life sciences solutions company NextDocs cites analyst estimates that companies will spend one-third of their IT budgets on cloud applica-tions and solutions this year.

Currently, large CROs and many large biopharmaceutical companies are in vari-ous stages of using cloud computing for clinical trials—a strategy that has reduced the use of on-premise computing. With the adoption of the internet as a comput-ing platform, sponsors and CROs rely on Software-as-a-Service (SaaS) for web host-ing services for clinical and non-clinical software such as Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS) and ePRO systems. An-other is Infrastructure-as-a-Service (Iaas), which enables access to servers, data cen-ters and network equipment without any

heavy initial investment; and Platform-as-a Service, which provides developers with the tools to create their own applications with-out costly IT investment in hardware.

Beyond those essential services, there is major growth in cloud-based solutions for other areas of the industry, such as TMF services, regulatory affairs, investigator payments and study start-up.

Still, implementing the right cloud-based solution can pose some tricky challenges, according to a recent Enter-prise Management Associates study in which 400 organizations worldwide de-scribe their cloud usage efforts. The study, Casualties of Cloud Wars: Customers are Paying the Price, found most firms col-laborated with up to three cloud computing vendors, suggesting they must work with several vendors to craft the right solution. Survey respondents said the cloud provided them with important benefits, including savings in costs and scalability.

The findings also showed 88% ran into at least one unexpected problem, the top concerns being complicated pricing mod-els and performance issues. The study concluded while the cloud may provide var-ious benefits, it is very important to seek out an assortment of vendors to find the right combination to match a company’s needs.

As cloud computing extends its reach into clinical trials, data analysis, analyt-ics and visualization are becoming key

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Company reports on the benefits of cloud computing platforms

Benefit Quantified impact

Higher quality Users of custom applications built on a cloud computing platform reduced annual downtime by 80%-90%

Lower cost Companies reported cost savings of 35%-50%

Improved performance Companies reported: • Efficiency gains of up to 25% • Number of annual upgrades doubled as a result of moving

to a cloud platform • Lower cost and higher quality contributed to an additional

$3 million to $4 million in annual revenue per organization

Source: IDC 2013; Interviews with operating managers in major corporations across multiple industries

Total spending on cloud computing in the global healthcare market$US billions

Source: Transparency Market Research, 2012

$1.8

$6.8

2011 2018 projected

20.9% annualgrowth rate

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areas. Trial managers want to see charts and graphs showing data trends far more dynamically than reading Excel spread sheets. Filters and graphical visualiza-tion tools enhance the previous reporting technology, which resembles the simple rows and columns of tables.

“They want sophisticated visualized ways of seeing the data and being able to slice and dice it on the fly—things they couldn’t do before cloud computing,” said David Kiger, VP of Product Strategy, PAREXEL Infor-matics. “Analytics has enabled them to see trends that are more advanced. This pro-vides more user flexibility to filter in ‘real time,’ as opposed to the legacy approach of having to create additional standard ver-sions of static reports.”

However, there are areas in which cloud computing has not lived up to expectations.

“There is a significant gap in this industry between the cloud services available now and the services the industry is looking for,” said Colin Orr, IT director at global CRO Icon. “The vendors simply are not keeping pace with the industry, which is changing very rapidly at the moment, with lots of consolidation and an enormous effort on reducing costs and increasing efficiency. Processes are changing, regulatory require-ments are changing and, you could argue, the way we are doing business is changing.”

He cited gaps in CRO capabilities including study start-up, investigator payments, additional developments needed in the CTMS space—but said improve-ments will be delivered in the next 12 months by software vendors. Those new capabilities, he said, will have a positive ef-fect on the way clinical research business is conducted.

“We need to see a greater availability of end-to-end solutions,” said Orr, “that have been designed with the cloud in mind.”

Email comments to Ronald at ronald.rosenberg@centerwatch.com.

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Case study in the cloud: Kythera BiopharmaceuticalsFinding clinical research cost savings by switching to cloud computing starts with paying less for internal IT services, as many of them, over time, disappear.

Nine-year-old Kythera Biopharmaceuticals—with 26 clinical studies on file including four active trials—had thousands of documents to share, manage and store. It was struggling with a patchwork of different document repositories and systems for each functional area, including a file-sharing system for Trial Master File (TMF) documents.

The biotech, which develops prescription products for the aesthetic medicine market, had multiple versions of documents floating in and out of different people’s hands with no reliable document accountability, as its legacy system was extremely difficult to manage and update.

Enter Veeva Systems, a multi-tenant cloud computing company. Its Vault, a suite of cloud-based applications, now connects Kythera’s teams from clinical to commercial, and links work stream activity across clinical, regulatory and medical affairs.

“As a growing company without an IT team, we needed a cloud environment,” said Renee Fate, Kythera’s senior manager of document management, adding that users in the company said they wanted more visibility with information available in real time.

Since the installation, Fate outlined some of the real-time results of the changeover to cloud computing:

• After protocols authored by the medical writer are uploaded, the requisite six or seven reviewers are automatically notified.

• CRO partners have access to clinical trial reports so they are better able to report back on trial status.

• The system is able to alert team members before documents expire.

• A site document report shows the study documents on file for each site and a site initiation report that reveals the status of documents for a specific milestone.

• Being paperless has helped study start-up, enhanced visibility into trial operations and ensured documents are organized in a common structure for easier search, retrieval and the ability to collaborate more efficiently.

• It has shaved at least 40% off the time needed to reconcile TMF documents at the end of a trial by using an eTMF cloud system.

“The biggest issue when it comes to transitioning to a new system—and letting go of paper—is the fear of losing control,” said Fate. “But when employees and partners see the increase in efficiency that comes from a more streamlined, repeatable process, they are more likely to embrace the system and accept a new digital business environment.”

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