Clinical Trials in the Cloud

I got a phone call the other day from a longtime OpenClinica user about the announcement of our new OpenClinica Optimized™ Hosting. He remarked on how leading companies in the industry (including his) are making big investments in cloud computing products and services, because these technologies provide easy-to-access functionality on an infrastructure that is more redundant, scalable, and cost-effective than you could hope to build or buy on your own.

However, in the clinical research field, putting together such an offering is not for the faint of heart. Though our free OpenClinica Community Edition has been installed and run by users on cloud servers for years, our OpenClinica Enterprise Edition offering (which carries regulatory guarantees) would have to meet rigorous reliability, security, and regulatory compliance requirements. How can this be accomplished if you don’t actually know where your data physically resides at any point in time on the cloud?

Prior to the launch of Optimized Hosting, we offered each hosted customer a dedicated server or two server (application + database) setup. This provided a certain peace of mind from knowing that your clinical data lives on a dedicated piece of hardware, but for many the costs were high and suffered from the inherent limitations of being tied to a physical machine. At the end of last year our data center partner achieved SAS 70 Type II certification for their cloud services, and we decided it was time to begin diligence on a cloud-based offering for OpenClinica.

We have spent the past 9 months listening to our customers’ needs and concerns, a designing and testing a solution. The resulting OpenClinica Optimized™ Hosting is an innovative hybrid architecture that provides the best of both worlds:  the scalability, high availability, and flexibility of the cloud combined with the peace of mind that your data lives in purpose-built dedicated hardware.Clinical Research in the Cloud

In short, OpenClinica Optimized Hosting offers greater fault tolerance, with better scalability and performance, at a lower cost than alternatives. Here’s how it works:

Application

Each OpenClinica application instance is a cloud server cloned from an image that has been qualified according to our exacting installation instructions. We configure the instance according to the customer’s supplied configuration parameters and complete operational qualification (OQ). The instance is typically available and ready for production use within a day or two. Thanks to the cloud, computing resources are instantly scalable on-demand.

Database

Dedicated (non-cloud) high performance database machines are configured in a master/slave relationship to provide instant data replication and fault tolerance. By utilizing multiple slave databases located in different geographic regions, the OpenClinica Optimized Hosting database cluster is designed for zero data loss even in event of nuclear strike. The servers use the fastest hard disk technology available today (Fusion-io®), dramatically improving database performance. For example, in our testing, we commonly see data extracts run up to 10x faster than in the prior environment. Database servers are physically isolated via CISCO ASA firewall to eliminate all nonessential access credentials.

Validation and Compliance

OpenClinica Optimized Hosting provides maximum flexibility and transparency in the area of change control and compliance. It has been constructed around a carefully designed set of controls to ensure all updates are fully tested (and documented) in the environment prior to release, and that customers can have upgrades and maintenance releases applied according to their individual schedules and priorities.

One of the great advantages of OpenClinica is the choice it offers – you can use and extend the open source licensed code, you can choose between OpenClinica Community Edition and OpenClinica Enterprise, you can deploy it locally or choose the hosted option. Or, any combination of the above. The new Optimized Hosting environment enhances that choice by providing a fast, reliable, and cost-effective way to get up and running with OpenClinica.

For more on security in OpenClinica Optimized Hosting, see Clinical Trials in the Cloud – Part II.

– Cal Collins

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