Articles
Losing Your Vendor
Seven Points to Keep In Mind When Facing the Loss of a Trusted EDC/eClinical Vendor That Can Help Ease the Pains
By Timothy Pratt, PhD
Originally published in Applied Clinical Trials, June 2008
Issues and Expectations
You'll be separated by a (un)common language. The terminology you've been used to using with your vendor may not be the same as your new vendor. A good example is where the previous vendor referred to an automatic "edit check" as a "query" and the new vendor thinks a query is something that a data manager or monitor issues manually within the system. This simple lack of understanding can cause frustration and delays, especially if the new vendor bids for one thing when you meant another. And there will be many examples like this, so consider developing a printed glossary of terms.
Given the difficulties in common points of reference, it is also even more important than usual that a very detailed and robust User Requirements Specification is constructed. In this instance do not assume that your new vendor knows (or should know) precisely what you want. You must be as explicit as possible in elaborating exactly what you want and need or you'll be almost guaranteed to get something that isn't, and that will take time and money to fix.
Processes vary from company to company. Your new vendor, if you've selected them correctly, has a robust set of processes in place to deliver a good product and service. Trouble is, you've been dealing with your old vendor for so long, sometimes for years, and their processes were different: For example, there will be a lot of change control going on during the changeover, and process mismatch is almost guaranteed.
If you want a speedy and quality job from your new EDC/ eClinical vendor, don't attempt to impose on them wholesale process changes in the middle of this project. Just because the processes aren't what you're used to doesn't mean they're wrong or poor. It will take an expert to assess the new vendor's processes effectively, though - more on that later.
EDC is not a commodity. EDC and eClinical systems are, by their nature, proprietary. That means they're unique. To expect that your new vendor can or should make a system exactly like the one you had before is unrealistic. There may be fundamental technology vector restraints that make replication either near impossible or highly burdensome, time consuming, and costly.
It always takes longer and costs more than you think. This one really hurts - you've already paid for a system after all. To get a new one in place will be at least as expensive and possibly much more, especially if a high degree of commonality is sought with the failed system (see point two: Processes vary from company to company). In addition, if your new vendor is telling you they can do everything in a few weeks, find yourself a different vendor that is prepared to be honest. The temptation, when frustrated and desperate, is to go with the vendor that tells you what makes you feel good, but it's at the risk of significant pain later on.
Switching over to a new system is not easy. Developing an understanding of all the fine nuances of the study and its intent is time consuming. Rushing things inappropriately will cause you to have quality issues.
