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Church Road, Harold Wood, Essex, RM3 0JU, UK

Tel: +44 (0)20 8817 5296

Email: info@triumphconsultancy.com



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Tel: +1 919 747 9400    

Email: info@triumphconsultancy.com



2002 - 2014 Copyright Triumph Consultancy Services. All rights reserved.


2002 - 2014 Copyright Triumph Consultancy Services. All rights reserved.

7100 Six forks Road, Suite 135, Raleigh, NC 27615, USA

Tel: +1 919 747 9400    

Email: info@triumphconsultancy.com


Unit 8, Elms industrial Estate

Church Road, Harold Wood, Essex, RM3 0JU, UK

Tel: +44 (0)20 8817 5296

Email: info@triumphconsultancy.com



Five common mistakes companies can make when implementing CTMS

(or any clinical system for that matter!)


27th March  2015

Duncan Hall, CEO Triumph





The concept of centralising the management and tracking of multiple clinical trials has been around for more than 15 years now. With all that wealth of experience as an industry, we should be learning from our mistakes. Sadly the reality is we still often make the same costly mistakes over and over again. So here are some pitfalls to watch out for with your next CTMS or clinical system implementation.….





MAKING TRIALS BETTER, TOGETHER

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1 - Not knowing how the CTMS is going to be used, and by who

In the same way you’ll hear real estate agents saying the three most importing things about choosing a house are location, location and location, I’d say with CTMS (or any clinical system for that matter) the three most important considerations are process, process and process. Having a clear view on the processes you want to execute in your CTMS and which roles will perform those processes can have a huge impact on the success of your project. That knowledge will drive product selection, implementation and configuration, training, validation and change management. Get it right and the rest of the project will make sense, get it wrong, or try to bypass it, and the rest of the project will be a series of guesses or ill informed decisions.

As an example, do you plan to execute study start up in CTMS? If you do, then you need to ensure the CTMS you choose will adequately support your start up process, and you will need to involve your start up team in the selection process. If you don’t, you may be needed to consider integration with an SSU product or migrating data into CTMS from multiple sources if start up is run more disparately. Which ever route you choose, the project and chosen product may end up being quite different.

2 - Engaging vendors too early

Despite me having stated already, that process definition is the most important factor in CTMS implementation, this is my personal bug bear! Not that I have anything against product vendors at all - they are a very important part of the selection and implementation process. It is just when and how you work with vendors that companies get so wrong.

If I had a dollar for every time I ask a customer what they’ve done so far on their project, and got the answer “well, we’ve started talking to vendors and had lots of demos” I’d have at least 50 dollars in my back pocket by now!

I know it is human nature to want to get started quickly, but taking this approach means that your lack of clear direction can result in your direction being forged by the strengths of the vendor’s product. The outcome of this is that over time you find yourself bending your requirements and ultimately the way you run your trials around the capabilities of the product, rather then selecting the product which most closely fits your needs and then making business decisions as to the value of further configuration to meet any remaining needs.



3 - Not considering the inputs and outputs

A CTMS performs two main functions - it captures data (either manually or by integrations) and it presents data for decision making and reporting purposes. In the middle of all that, depending on the system, there may be workflow management, some derived fields and an automatic status or alerts generated, but fundamentally it’s all about the capture and presentation of data.

So with that said, you need to go into your selection and implementation project with a very clear idea of what data is going to be held within the CTMS and where that data is going to come from. You then need to ensure that the systems you are looking at enable the capture of that data, or allow simple configuration to capture that data. Again, the clearer you can be about your needs with the vendors, the clearer a response they can give you. For example, if you ask a vendor “does your CTMS allow financial tracking?” The answer will almost certainly be “yes”. But if you ask “does your system allow the capture of exchange rates, allow grant tracking in multiple currencies, and allow the capture of country specific tax rates” you might not get such a simple answer.

Where is your data coming from? - do you intend to pull in data from external sources (EDC being a common requirement)? If so, does the CTMS have the appropriate APIs to work through? Does the vendor already have integrations to common EDC’s buit?  How will the data be validated on entry to the CTMS? What if there is duplicate data? Can the vendor demonstrate data being imported? There are all important questions and will be driven by a clear understanding of what you expect from the CTMS and any interfacing systems.

And on the reporting side - what do you want to get out of the CTMS? What decisions do you want to make? What do you need to report in, to who and how often? Do you want tabular reports, graphs, pdfs, analytics? Does the CTMS have the capabilities you want ,or will you need to use a 3rd party reporting tool? Do you want reports pulled from the system, or do you want them generated automatically? These are just a few of the considerations you need to make before selecting your CTMS. Many CTMS include out of the box reports. In my experience these are not often very helpful and tend to be simple lists of data rather than operationally driven. Again, if you have a clear understanding of your reporting needs you will be able to assess the value of what comes with the CTMS and what needs to be developed during the implementation.

4 - Lack of focus on change management and training

We’ve written many items on this point before, but it still comes up time and again. Whether you are going from paper based trial management, or Excel and Word, or migrating from another CTMS it doesn’t matter - the impact on the end users is going to be significant. If the change impact isn’t properly investigated and managed, and the process of change built into both the implementation, training and roll out of the CTMS you are likely to hit issues with user adoption, data compliance and data quality. This can quickly result in increased support costs and high levels of and user and management frustration. Change management is about understanding how a system is going to be used, why and how that is going to impact current working practices (see the importance of point 1). It is about understanding old habits and being creative about creating new ones. It should be a budget line item from day one and should be measured as a success criteria in the same way you might measure budget or timeliness.


5 - Business case

This can be a thorny one, but you’d be amazed how many systems implementation projects go ahead without a business case in place. I can almost guarantee that even if you get the go ahead for a project without one, you’ll be asked for it at some point during the project, usually after a change in senior management!

If you don’t know what you are shooting for, how do you know when you’ve got there? If you don’t know how much the system is going to save you, how do you know what a reasonable budget for the project in the first place is? Having a well thought through business case help align the business around your project, it help management to prioritize and ensure that the right resources are made available, and it helps you involve the vendors in what you expect will be a shared win. At the end of the day it is just good common sense business practice, and that’s hard to argue against!



Triumph have been helping companies with CTMS implementation for more than 13 years now, and have delivered more than 20 CTMS projects.


If you would like any further information or advice on how to approach CTMS selection and implementation, please feel free to contact us at info@triumphconsultancy.co.uk