Bryan Clayton, Vice President, Strategic Solutions

 

On October 25, I presented a webinar to discuss IRT terminology, SDLC methodologies and how different approaches can save time, risk and cost.

Though they may seem similar, customized and configurable systems are quite different. Each approach presents its own set of challenges.  Before I started my main presentation, I polled the audience to find out what kind of IRT system they currently work with. Below are the results from that poll:

 

Not surprisingly, the largest percentage fell under 80% configurable/20% customized, which is what we see most commonly across all our clients.  For many years in the IRT world, we have been searching for the elusive 100% customizable IRT system. However, more and more of us are starting to realize that system does not exist.

Before moving on to clarifying IRT terms we hear often, I asked the audience to participate in an exercise to better understand how to interpret requirements and the difference on the ground between customization and configuration. When we spend our time on customization and specification documentation and don’t allow our customers see what we’re working on in real time, our risk of getting it wrong is very high.  You can watch the exercise in its entirety here at the 6:00 mark.

Demystifying IRT Terminology

Our industry, like many others, is full of acronyms.  In our line of business, there are myriad terms used and many of them mean the same thing.  I spent some time discussing and clarifying those terms.

IRT (Interactive Response Technology), IVRS (Interactive Voice Response Systems), IWRS (Interactive Web Response Systems) IxRS® and RTSM (Randomization and Trial Supply Management) – all mean the same thing.

Do not dates, stopping dates and DNX dates all mean the same thing: do not ship/dispense or stop shipping/dispensing.  What isn’t always clear and a question I often get asked is is this the last day the drug can be dispensed or is this the first day the drug will not be dispensed? Without a clear answer to that question, there can be major implications.

Forecasting period, look ahead and short window are also analogous for describing re-supply strategies.

Configurable v. Customizable

That brings us to two of the most commonly used and misused descriptors for IRT functionality: configurable and customizable.  A customized system is one with features or modifications that requires custom coding and/or implementation.  A configurable system is one where you use existing tools within the system to change its behavior or features.  Though they are similar, the key differences come down to time, cost and scalability.

A configurable system is designed to make the process of building an IRT system easier.  Timelines are shorter, risks are reduced because configurations are pre-validated and reduced time to get a completed product, lowers cost.  Since everyone wants to reduce time, risk and cost, why even consider customization? As we saw earlier through our audience polling question, most IRT systems are 80% configurable and 20% customized. This is often due to the system requiring some type of additional functionality that isn’t part of the configurable platform.

Clinical trials continue to become more complex, necessitating custom code or features.  It is becoming increasingly common to integrate eClinical systems with third party systems, notably e-consent and patient engagement which require additional software development.  The final and most exciting reason for customization is innovation.  We all want to do something else to help to engage our patients, help create innovative trials and design the trials of the future.

If you decide to invest in a configurable system, make sure the provider can show you the configuration.  Ask who does the configuration - a project manager, configuration engineer or a developer?  If it is anyone other than a developer, ask if they can show you that configuration in real time.  If it is a developer, ask if they configure by writing code or by using an interface.  If it’s code, then it’s not configurable and will require additional testing.  If it’s an interface, request to see the configuration in real time before making a decision.

The big takeaway? Configurability can save you time, risk and cost.  Customization requires custom-developed code which means you need full end-to-end validation which takes time, which also means increased costs.

Advanced Configurability

In the world of IRT, there are pre-defined and pre-validated modules for activities like screening, run-in, dispensing, and these modules can either be based on the sponsor’s standards or the IRT provider’s standards.  Whether a provider like YPrime, a sponsor subject matter expert or a CRO certified designer builds the standard modules, the end product has the same things in common – pre-defined and pre-validated modules.  From that point, you can simply drag the required functionality into the system to build your study.

As trials get more complex, we are asked to incorporate more and more advanced functionality into our IRT systems.  For example:

  • Calculations
  • Business rules (if-then)
  • Business logic

YPrime’s calculation module is a powerful tool that is able to take things like demographics from the screening form, multiply them by different values that are constants on the back-end of the system and manage things like weight-based dosing.

The business rules engine allows us to compare values and determine functionality.  For example, if the site is active, the patient status equals screened and the answer to the question is the subject over 18 years old equals option 1, then the patient is eligible for randomization.

Business logic simply addresses what happens after you hit the submit button.  Using simple drag and drop methodology, you can define what will happen after variables are collected and hit go.

Though configurable tools can be quite robust, some customization in your IRT system may always be necessary.  You never know when you’ll need new functionality or when a new technology will become available that requires integration with an IRT system.  When deciding whether or not to customize, keep these things in mind:

  • What is the level of validation needed for system implementation
  • Is there another way to do this?
  • If we must do this, how much will it cost and how long will it take?

System Development Life Cycle Methodologies (SDLC)

Finally, I discussed SDLC and how configuration is tied to the agile methodology.  The focus in agile methodology is working software.  YPrime also allows sponsors to see the software many times before it goes live.  Since there is a high amount of visibility during development, you see your system every two weeks or so and are able to ask for adjustments as necessary.  By the time we get to the UAT stage, you’ve seen the system at least 3 or 4 times.  When it comes to how configuration and customization relate to the agile approach, it’s important to keep in mind that the ability to change remains very high when building a configurable system but starts to rapidly decline in a customized system.  This is because once the custom code has been written, the ability to rip out that code and re-write it will take time.

The risk of delay is also significantly reduced when using an agile approach.  For example, if you have 8 weeks before go-live, and you’re still writing custom code at 4 weeks, there is a substantial risk for delay.  However, if you are using agile methodology with configurable software, risk decays rapidly at that same 4 week mark, thus greatly reducing risk of missing your timelines or going over budget.

Key Takeaways

  • Customization=time and money. However, there may be times when you need it!
  • Be creative but fair. If you’re asking a provider to develop custom functionality, make sure you understand it’s going to take the developers and testers additional time to write custom code.
  • Work within the framework of your standards if you have them.
  • Evaluate how else to accomplish the same thing. Ask your provider if there is a way to accomplish something within their configurable system to avoid additional customization.

You can watch the webinar in its entirety by clicking here.