This contribution to ’52 Perspectives’ comes to us from Gary Urban. Gary has twenty-five years of experience in the areas of Quality Management Systems (QMS), Clinical Services, and Information Technology. Here, Gary describes his thoughts around how the advent of the software as a service (SaaS) impacts the future for the better.
Introduction
Having worked in more than one small to medium-sized company as the head of Information Technology, I quickly learned the many challenges to be faced while trying to implement the infrastructure necessary to support the business operations and processes, one of which is finances. Though senior Executives, i.e. those who approve the capital expenditures budget, certainly recognize the need for appropriate solutions, technology is rarely the core business of the organization. For the last 15 years of my career, that core business has been serving as the outsourced provider to conduct clinical research trials.
Beyond financing, the time required to create innovative solutions to meet the needs of the business is also a concern because even the development of a moderately robust software application can take years, leaving the operational business units to hobble along with work-around solutions, such as the much loved (and maligned) spreadsheet.
Yet another challenge with trying to develop your own solutions is pulling the business experts away from their primary job function to define the system’s requirements which, in consultancy organizations, not only means that customer needs are going unaddressed, but revenue is also not being generated because billable resources are sidelined to meet internal needs.
The complexity of these challenges has even spawned a niche industry, that being companies which provide the service of assessing an organization’s technological infrastructure needs, and making appropriate recommendations based upon the risk and value that implementing the solutions would present.
For anyone who has worked in Information Technology (IT) in the clinical research industry, you will recognize that, for all of our willingness and ability to advance healthcare globally, we can be surprisingly slow to adopt new technology, though one software model may be about to cause a dramatic shift in that hesitation.
Enter Software as a Service (Saas)
Innovative solutions to address critical business needs are now available from a variety of forwarding-thinking organizations, one of which is goBalto. Their product is making considerable headway in simplifying and streamlining the myriad of clinical study start-up activities such as selecting appropriate investigative sites based upon detailed capabilities information, including access to the site’s previous subject recruitment and retention levels. Other such SaaS solutions are also readily available, from IVRS/IWRS systems for investigative product randomization, to Electronic Data Capture of Case Report Form data.
The Future
Such solutions have been a long time coming, and are beginning to make the lives of IT leaders and professionals far less challenging – and businesses more productive and profitable. Imagine being able to offer your organization innovative solutions without the delays, cost and impact to the business of having to develop them yourselves. SaaS allows your organization access to these solutions without the programming and development staff required to maintain them, and even without the servers and other overhead required to support what can easily become an ever-growing technology infrastructure. Imagine all this, today; it has arrived.
About Gary Urban:
Gary has twenty-five years of experience in the areas of Quality Management Systems (QMS), Clinical Services and Information Technology. As a clinical, compliance and QMS consultant, he provides tailored solutions to meet client’s needs.
As Paragon Biomedical’s Director, Global Quality Management Systems, Gary worked across the organization to ensure Paragon’s QMS model, systems and documentation library supported the highest levels of quality, efficiency and profitability world-wide. Gary was with Paragon for 10 years, and also served as their Director, Clinical Services and Director, Information Technology.
Prior to joining the clinical research industry 15 years ago, Gary worked in the Insurance and Healthcare industries.
