Timothy Pratt, PhD
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This is the second article in a two part series. The first article, published in March 2008 entitled "The Vendor Tango," dealt
with four important nonproduct characteristics that should be examined carefully when selecting any support partner, especially
an eClinical technology provider: These elements were financial stability, company size, company experience, and personnel
stability. I encourage you to go online to the Applied Clinical Trials' Web site ( http://appliedclinicaltrialsonline.findpharma.com/) to review that article if you're not familiar with it.
If the points raised in "The Vendor Tango" are not borne in mind, the sequelae can be extreme and pose a serious threat to
the successful completion of your research. Poor vendor selection can yield results that range from poor performance, inefficiencies,
and increased cost through to total vendor collapse.
This article will look at what can easily become a nightmare scenario of vendor collapse during the course of your clinical
study. It's also broadly applicable in the event of a major service disruption or acquisition, where a change in vendors needs
to take place. This topic is germane and important to all consumers of eClinical technologies and could easily fill many pages
of this journal and not adequately cover everything—so this article will necessarily be a synopsis of the most salient points.
Buckle in because it's going to be a rough ride.
The scenarioYou're in the middle of your study; it's an approval/pivotal study (although during a postmarket study intangible effects
can be even more far reaching and damaging) and all of a sudden your EDC/eClinical vendor collapses. You panic—and that's
okay, you probably should. The future of your company, your job, your reputation, customer relationships, and more all depend
on getting this product approved on time.
PHOTOGRAPHY: GETTY IMAGES ILLUSTRATION: ISABELLA BLUMBERG
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You gather your team quickly and identify potential vendors and select one. Now what? EDC is a commodity, so you'll just be
able to switch over, right? Not so fast—you're about to find out that you will face special challenges, not least of which
is the realization that EDC/eClinical is not a commodity and it doesn't "plug and play."
Think about it: You're about to take three to six months of development time—and sometimes years of an ongoing relationship
that you enjoyed with your failed vendor—and attempt to compress that into as short a time frame as humanly possible with
a company you've probably never worked with before.
Communication will be hard. Synergies and understandings will not have had time to develop since people have not yet formed
productive relationships. Your team, perhaps even the whole department, is stressed and frustrated. The usual data cleaning
activities at study closeout haven't been performed, the data quality is unknown, and senior managementis worried.
These are all special challenges that weren't present the first time around. So, let's examine some of those challenges and
outline strategies and tactics to mitigate risk and set appropriate expectations.
