The systems used in clinical R&D (or commercial, or HR, or finance…), like everything else in the world (people included), eventually grow old and stop working the way we’d like them to. Fortunately, these systems can be replaced – though not necessarily any more cheaply or easily than your Uncle Irwin’s hip. Done the right way, however, finding and implementing a new system can be relatively painless. Even better, the end result will be something you’ll be happy with. There will be work involved, sure, but unless you want to be stuck – again – with a system that adds no value to your organization, I’m sure you’ll agree that these six steps are worth doing.
Write a Business Case
I know what you’re thinking – “We know we need a new system, so why in the world do we need a business case?” It’s a fair point. But “knowing” something isn’t exactly the same as knowing it, if you know what I mean. The bottom line is that your company is about to spend a truckload of money on this new system, so it’s probably not too much for the powers-that-be to ask for a little justification for the purchase so they can show their powers-that-be that this is a wise move. If it’s so obvious to everyone that a new system is needed, then this step should be a breeze, and this doesn’t need to be a Harvard MBA project either. Just including some of the basic building blocks of a business case – such as assumptions, the financial model, benefits rationale, risks/contingencies/dependencies, and of course a final recommendation – should be enough to show that purchasing the new system is prudent. Besides, in 7 years from now when people are wondering why you ever did this in the first place, you’ll have some documentation to fall back on.
Requirements are a Requirement
A system will only be as good as the requirements collected for it – skip this step at your own peril. It is here where you will be defining the detailed business needs and thus prioritizing what features are most important to your organization. That word prioritizing is key – chances are you won’t ever find the “perfect” system, so you’ll need to decide which handful of features you will base your evaluation of each system on. These requirements list can get long, but keep in mind that the length of your requirements document should be roughly proportional to the importance of the new system across your entire organization. You shouldn’t have a list of 400 items for a system that will affect a single 15 person department.
Write a Clear RFIsite feas
Once you have some basic requirements down, you’ll need to take a look at the landscape of vendors that can possibly provide what you need. By now you should at least hasite feasve your high level requirements. Thanks to the internet, you shouldn’t have a much of a problem figuring out who these vendors are and thus getting a “long list” of candidates. Providing these vendors with a clearly written request for information (RFI) will help them to understand your expectations and show you how their system can meet your needs.
Narrow Down the List
You may start with a relatively large number of vendors on your “long list”. Setting up a series of relatively brief demo meetings (an hour or so should be plenty of time to get a sense of things) is a great way to start paring down your list to a final two or three candidates. Focus on your high priority features and eliminate the ones that can’t meet your “must have” list. As you’re doing this, you’ll also need to be creating your final RFP to send out to the remaing few vendors. This final RFP should include your detailed requirements list so vendors can be prepared to demonstrate how their systems meet your needs.
Get Ready for the Dog & Pony Shows
Prepare for sales forces to storm your castle – once you have your “short list” identified, it’s time to have the vendors come in for a more rigorous meeting where they will (attempt to) show you how their system is best for your needs. You will in turn grill them on everything from how their back end database is structured to what they had for breakfast last Thursday. Prior to these meetings, it’s a good idea to develop some kind of weighted scorecard (based on prioritized requirements) for everyone to use to evaluate each system. Expect to spend a good portion of a day delving into the nitty gritty of not only the vendor’s system but how they provide service to their clients. Do they have a dedicated project manager to oversee installation? What system training do they provide? How about their help desk?
Now that you have all of your information, it’s time to decide. That doesn’t mean it’s time to have 17 more meetings and call in the vendors five more times (you won’t need to do this since you already followed the five previously detailed steps…right?). Studies have shown that, beyond a reasonable amount of “due diligence”, buyers tend to be less happy when they spend an inordinate amount of time doing research before a purchase. Follow up with the vendor with any questions you may have, of course, but don’t expect a sudden epiphany or sign telling you what to do. Your decision should be made through open conversation amongst the project team based on what was observed in the vendor meetings. The scorecards are really there to validate what the verbal consensus is (hopefully; if the consensus and the scorecards do not align more talking needs to be done). Note that at no point has money really played a factor in the decision. Again, that’s where the business case from the first step comes in – since it was developed early on with certain (hopefully reasonable) assumptions about cost, this has already been addressed. If needed, the cost model can be updated to reflect the actual proposed vendor costs to verify that the numbers still make sense.
Keep in mind the vendor selection is only the beginning. The implementation is often where these projects fail. Check back in the near future for a blog post on the things that need to happen to ensure a successful implementation. Whether you’re looking for a new clinical trial management system (CTMS), electronic data capture system (EDC), electronic Trial Master File (eTMF), or any other system, following these six steps can help make sure you get the right system. Uncle Irwin is on his own.