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Cloud-Based eTMF Solutions: A New Approach to Clinical Trials Management
Clinical trials are still one of the most costly, yet strategically important, areas of any life sciences company today. And as these companies continue to expand globally and outsource more of their clinical trials operations, the process grows even more complex.
In the best interest of boosting efficiencies, many life science companies are considering moving their clinical trials documentation and other content to the cloud. The regulated, multitenant cloud allows Pharmacos to focus on core business activities, and less on IT maintenance issues.
“The way I see the industry going, if a pharma company cannot crack the nut on how to improve efficiency, they will not be around much longer,” said Michael Burton, head of strategy for Vault eTMF, Veeva Systems.
An electronic master file - or eTMF, is a solution developed for managing clinical trials content. To help life sciences organizations improve operations, the secure regulated cloud is available for regulated clinical trial content. One of the benefits of this, Burton explains, is having a single electronic trial master file application for all users across a company and its global partners.
Private vs. Regulated Cloud
“When we talk about the cloud, we need to be very clear about what we mean, as there are many different meanings to that word these days,” said Rik Van Mol, vice president for Vault Services, Europe.
Life science companies are still experimenting with private clouds (i.e., hosted systems), because they believe that they offer a greater degree of control and security. With a private cloud, the company virtualizes its data centre and client/server applications to leverage the economies of scale of the cloud, but only at an individual company level. Moving to the private cloud can offer some incremental cost benefit compared to on-site solutions, but it does not offer the same level of shared efficiencies that a multitenant solution in the regulated cloud affords. The regulated cloud is built and operated in a validated environment to meet the robust standards and regulatory requirements of the pharmaceutical industry. And because it is multitenant, it does so in a more efficient way. For example, it can be pre-validated once for the entire industry rather than for each individual company saving each individual “tenant” countless hours and dollars.
“This is a breakthrough in value for the life sciences industry,” added Van Mol.
The game-changing massive economies of scale that so many think of when they talk about cloud computing can only be realised if the system is multitenant. Multitenant applications delivered in the regulated cloud essentially deploy a single application that’s custom-configured for each customer. It’s fundamentally the same architecture for every customer so upgrades and changes – say, for example to meet a new government regulation – automatically occur across all users simultaneously.
“Because the pharma industry changes so rapidly, and companies are obligated to comply with shifting industry regulations, a multitenant platform in the regulated cloud has proven the optimal choice,” Van Mol said. “It enables pharmaceutical companies to keep up with frequent upgrades, enhancements and regulatory changes that are only possible to deliver cost-effectively on a true multitenant architecture.”
Another important characteristic of the regulated cloud is its high security. The cloud hosting organization knows where all a company’s data is at all times and can protect its data centres with world-class infrastructure and security mechanisms. This, in contrast to a cloud provider like Amazon where data could be anywhere in the world at any given moment.
Cloud-Based Content Applications
Today, there are new content management applications in the regulated cloud designed to support clinical trials such as the electronic trial master file solution. For example, eTMFs gives sponsors, sites and CROs around the globe real-time and secure access to clinical documentation at every point in a trial's set-up, execution and archival.
“Advanced eTMF applications are out-of-the-box solutions that don’t require much configuration,” Van Mol said. “Implementation could take as little as four to six weeks depending on the amount of clinical trials data a company needs to migrate to the cloud.”
Some of the benefits of eTMF software include:
- Deep Trial Master File Functionality —Sponsors and CROs benefit from specific functionality to speed study and site start-up, support for the DIA TMF Reference Model, submission-ready rendering and auditor review support.
- Improved Compliance and Quality — When eTMF becomes part of the normal workflow, content gets added in real time, status reporting becomes more accurate and the entire team is able to make better decisions. Overall compliance and documentation quality improves.
- Seamless Collaboration — eTMF provides a single, secure place on the Internet for all clinical players to share their documentation, in a standardized and fully reportable system.
Additionally, when built on a regulated, cloud-based platform, eTMF applications can scale to support even the very largest global clinical trials. And with SaaS pricing and deployment models, an eTMF can also support one-off small studies for CROs or virtual biotechs.
“Cloud computing is, by nature, very scalable,” Van Mol said. “You will see the smaller players getting the same kind of benefits from eTMF as bigger companies, and as these smaller companies grow they can do this very fast without worrying about their IT costs skyrocketing.”
Meeting the Global Challenge
The scalability of a multitenant platform in the regulated cloud helps life science companies meet the challenge of improved coordination of clinical trial materials across different partner locations worldwide. Pharmaceutical companies are expanding well beyond the western world and into the developing world, requiring interaction with CROs in China, India and Latin America where IT infrastructure is still immature. A multitenant cloud solution enables secure access to the system for these partners.
Cloud-based content management allows for a single repository of information where collaborators from around the globe can share documents. Importantly, this collaboration does not require any breaching of company firewalls. It takes place in a secure, regulated cloud environment that is separate from a company’s own infrastructure.
“The cloud CMS providers have a master set of regulations that they comply with, which covers the FDA and European requirements,” Van Mol explained. “However, we also have the flexibility to configure an eTMF to ensure compliance in other regulatory environments when needed.”
This flexibility is aided by those eTMF applications that organize documents into binders. The same clinical trial document can be used in multiple binders, for example, in different countries that need a differently structured eTMF. Because a document always comes with workflow metadata, there is never any risk of broken audit trails when communicating globally.
Integrating the eTMF with Other eClinical Systems
So, how will eTMF function in relation to companies’ existing eClinical portfolio, including clinical trials management system (CTMS)?
“We expect that the eTMF will sit within the clinical trial portfolio, which is already in place,” Burton offered. “We want to speed up and simplify a company’s regulatory submissions, not add to their already heavy workload.”
The expectation, Burton continued, is that a company will set up and maintain their clinical trial using their CTMS, while generating clinical trial content in the other systems in place. When the eClinical systems are integrated with the eTMF, those documents would be automatically available for the organization in a submission-ready eTMF.
“The goal of a cloud-based eTMF system is to make compliance less of a hassle by streamlining and simplifying the process of compiling a trial master file,” Burton said. “Of course, efficiency is what everyone is focused on, but what trumps everything is quality. When eTMF software is hard to manage this means that the quality of the trial master file and submission is affected, and this puts companies at risk of non-compliance.”
When built in a regulated public cloud, an eTMF system offers a simpler way for pharmaceutical companies to manage all of their clinical trials content to ensure both quality and efficiency.
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