Y2K Gave Way to Life Sciences Solutions
Michael J. McNees
Victor D. Thomas
Syndicus, Inc.
March 4, 2014
Syndicus Life Sciences
Back in 2000, when the Y2K work came to an uneventful IT close, the CIO of a major pharmaceutical firm
met with us and said “There’s no one I’d rather have to do my 21CFR11 compliance work than my IT
Outsourcing company.” So, since the consulting firm at that time provided all application management
services for this $40 billion firm’s legacy systems, it required some quick research into the meaning of
21CFR11. Once it was understood that this regulation went beyond the “process validation”
requirement of 21 CFR Part 211, it seemed like a good opportunity to start a Life Sciences Solution (LSS)
firm. This new firm became an official corporate entity in 2003 when we acquired more than $30 million
worth of work with a variety of pharmaceutical and medical device firms.
There were 400 consultants working in this company across North America, Europe and the Caribbean.
And we thought that Computerized Automation Validation System (CAVS) would be a nifty solution to
use in Life Sciences. CAVS never really paid off and this initial LSS unit lost focus in 2006 when its leader
left the large consulting firm (~$500 million in annual revenues) to start a new company on his own.
So this brings us to 2007 and the startup of Syndicus as a staffing and solutions firm. It took a while to
convince subject matter experts to follow the entrepreneur, path but now Syndicus had added its
Managing Director, Delivery Manager, Testing and Validation expert, and Business Development
Executive.
Industry Perspective
Over the past 15 years, Life Sciences had been focused on validation and the documentation of systems
installed for good pharmaceutical practices (GXP). More recently, the industry has shifted to quality
systems that focus on maintaining and sustaining GXP associated with drugs and devices to protect the
general public. Company executives and industry policymakers are now seeing the benefit of engaging
manufacturing staff to help develop more ”quality systems” associated with continuously improving
drugs and/or medical devices for U.S. public consumption.
Much like the industry it services, Syndicus is also evolving. In 2007, it initiated its Life Sciences practice
to provide management and technical consultants skilled in GXP applications to companies needing
assistance with Food and Drug Administration (FDA) regulatory compliance. Understanding the need to
support major pharmaceutical companies and medical device manufacturers in their overall business
practices, Syndicus established its Center of Excellence (CoE).
Future Plan
Although its original purpose was to assist pharmaceutical companies under Consent Decree, or under
the threat of one, the Syndicus CoE vision has grown to bring together a collection of compliance,
operation and technical experts. These individuals work with companies’ senior management to develop
solutions to in-house and healthcare industry compliance issues. Currently, the biggest issue facing
pharmaceutical companies is the inability to implement new technologies to increase operating profits
in a compliant environment.
Although Syndicus’ CoE is only six years old, we are already planning for the future. As the next step in
client engagement, we’d like to incorporate webcasts and social media into our communication process
with our clients to facilitate more contact with experts who specialize in particular areas, such as clinical
trials, research operations, biotech and more. Also, we continue to grow our technical staff, as we
envision using our CoE in the manufacturing sector to help eliminate technological defects, minimize
waste streams and re-duce variations around product-defined specifications.
Strategically, Syndicus combines its three consulting practices – HIT, Life Sciences and Technology
Services (cyber security) – to enable electronic patient health information (ePHI) for health information
exchange to optimize providers’ supply chain. This includes drug and device optimization, clinical
research opportunities, as well as a healthcare-delivery feedback loop. It’s all about patient-centered
outcomes ultimately.