David Kramer

CIO/CTO

My Red Hat® journey began in 2007 when I went to work for Red Hat. I was quickly submersed into Red Hat Enterprise Linux® and achieved my first RHCE® within 90 days.

When I joined Mytrus in 2010, I had to build the infrastructure by myself and prove to the FDA, IRBs, and our sponsors that the Red Hat ecosystem was big enough to handle all requirements and compliance regulations.

The business problem Mytrus solution solves is simple, but has never been done before. With clinical trials costs at an all-time high and pharmaceutical companies desperately needing to cut costs, Mytrus Direct-to-Patient Clinical Trial solution was ready to be unveiled to the healthcare industry to reduce costs by 35%.

Mytrus has developed a Platform-as-a-Service that gives our patients the ability to participate in clinical trials from their home using PCs, tablets, and smartphone technology. As an RHCA, you cover all aspects of the infrastructure stack from virtualization strategy to service redundancy to storage to systems management.

Becaues I was the only systems engineer building the solution, it made sense to use Rackspace's managed hosting environment so I could architect the hardware infrastructure and have them maintain the physical aspect.

This left me with designing a robust solution to handle the Network Change Control required in an FDA environment. For this, I leveraged the Red Hat package ecosystem consisting of RHN, EPEL, Zend, and a custom yum repository. Next was maintaining system's state consistency across all environments, from Rackspace to local sandbox instances running on many platforms. For this I leveraged Puppet and mCollective from EPEL. Puppet provided the configuration consistency combined with md5 checksum outputs that are used for traceability in FDA/Sponsor audits. mCollective gave me the Server Orchestration with several custom facts to control all the environments. Although Puppet and mCollective are extremely powerful tools, I still needed a build/application deployment tool that could work across all instances (Private Cloud and developer/QA sandboxes).

I wrote a custom Perl program that was tightly integrated with Puppet and mCollective. I developed a build tool that contains approximately 20 build targets to handle all environments and build variants for deploying web content and database changes, providing FDA level audit logs.

My RHCE taught me the basics for setting up FDA audit level secure Network Services such as HTTPS and SFTP. My RHCA taught me the larger picture of Enterprise Architecture and how important consistency across System images is vital to maintaining Network Change Control and how redundancy is key to maintaining data integrity and high availability. My previous experience allowed me to have the understanding of having a robust build system and how to leverage Red Hat Ecosystem to get the tools needed (RHN, Puppet, mCollective, PERL) to achieve the implementation of this platform by myself.

Today, Mytrus, Inc. is a first space mover in the healthcare clinical trials industry and is the first ever FDA/Sponsor approved clinical trial and was launched on an open source stack running on Red Hat Enterprise Linux.