Managing patient visit schedules during clinical trials can be a daunting task. However, with the right tools in place, organizations can significantly streamline this process and increase protocol compliance. That’s where a clinical trial management system (CTMS) comes into play. Imagine creating and editing study calendars that enable you to track visits and activities. Now imagine applying those calendars to any subject participating in a trial with just a few clicks, all while giving you the ability to customize the details on an individual and on-going basis.

In the video below, I provide a brief overview of the subject visit template (synonymous with study calendar) functionality in ASCEND, Perficient’s pre-configured Siebel CTMS solution, and how you can apply such a calendar to all subjects or patients in a trial.

If you would like to see a more detailed demonstration of the system, or if you have any other questions about our Siebel CTMS accelerator, please drop us a line.

We’re all users of software. Put us in front of two systems – one that looks outdated and unorganized, and one that looks good and structurally makes sense – and I bet you’d gravitate to the latter one. In fact, although I didn’t conduct a poll, I’m sure we’d all choose the latter. It’s not rocket science.

That gut instinct is something that usability experts have been talking about for decades: a great way to increase the user adoption of a software system is to brand the system to match your company’s look and feel. Give it the same colors. Put your logo on it. Match your company’s font preference. And, so on. Giving it that familiar look and feel will help make users more comfortable with the system, which will encourage them to use it more.

The video above shows you how simple it is to change the branding or theme in Oracle’s Siebel Clinical Trial Management System (CTMS), whether the theme is one that comes out-of-the-box or one that’s custom-developed.

How many comprehensive IT solutions, and more specifically those that relate to the clinical trials space, have the ability to be implemented on-premises or hosted in the cloud, in just a matter of weeks? Not many. When it comes to clinical trial management systems (CTMS), there are even fewer.

ASCEND, an Oracle Siebel CTMS accelerator, is pre-configured to meet the rigorous requirements life sciences companies have. From subject statistics to the tracking of protocol deviations, electronic signatures and trip report management features, the system typically meets most requirements out-of-the-box. Don’t forget, it was designed with the most commonly-requested features in mind. And because the new Siebel CTMS platform is so highly configurable, ASCEND can continue to adapt to your company’s evolving needs as it updates its processes, aims for improved compliance, and more rigorous quality management. Oh, the solution is fully validated and 21 CFR Part 11-compliant, too!

It’s not uncommon for system implementations to take a year or longer, especially in our highly regulated space. Reducing the need to add enhancements, combined with the option to host in the cloud, can provide a significant cost savings and shortened implementation timeline.

As you compare the different CTMS solutions in the marketplace, make sure you ask yourself some basic questions:

• Does it have the features I want? If not, what will it take to get there from a cost and time perspective?
• What are my deployment options?
• What does the implementation timeline look like?
• Is the solution validated?
• Is it 21 CFR Part 11-compliant?
• Are there companies like mine already using the system?

Based on just a few questions, you may be able to narrow down the list of contenders and begin a more detailed evaluation process with demonstrations and the ability to test it out for yourself in a sandbox environment.

Follow Perficient’s Life Sciences blog on Twitter via @Perficient_LS.

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Ask any IT project manager what one of their greatest challenges is when it comes to putting together a project plan, and they will likely tell you: estimates. According to a study published by Harvard Business Review, one in six projects presents a cost overrun of 200% and a schedule overrun of 70%, with the average cost overrun being 25% for the 1,471 IT projects studied.

While estimating CTMS project costs and timelines is not an exact science due to unplanned project requirement changes, estimation is still a necessity in order to finalize plans, keep projects on track and ensure the client’s budget is respected. So how do you increase odds at success, when numerous studies show that over 50% of IT projects fail to deliver? There are of course many success factors to consider, but producing solid estimates are very high up on the list. 

Some say that estimating is an art, and while it is true that gut feeling based on past experiences can be considered quite an asset, one needs to bear in mind that no two CTMS projects are exactly alike, not only in terms of tasks and context, but also the resources that make up the combined client and partner team. So in most cases, it takes more than a gut feeling.

Common mistakes that lead to the inaccurate estimation of CTMS projects include:

• Lack of time to put together solid, founded estimates
• Little contingency to account for events such as illness, vacation, and other unexpected events
• Time for project management, coordination, status meetings, etc. not accounted for
• Insufficient level of detail of requirements and/or tasks
• Assumption that client resources are fully available

The consequences of poor estimates are harsh. If your project is late, you will need to spend time re-estimating, re-prioritizing, figuring out workarounds, and scheduling more meetings – time that could have been used on delivering the actual project. It’s a vicious cycle with precious productive time being taken away, sinking the project into more trouble. And for clients, every dollar counts. In addition, as pressure on resources increases, quality suffers and the damages will creep up sooner or later and will hurt the client’s goals. For these reasons, it is essential to take all contingencies in your plan into account and not make any of the common mistakes presented above.

And, if a client tells you up-front that they have a certain budget, don’t decrease estimates to squeeze everything in. Instead, commit to implementing as many requirements as possible within that budget, or see if there are ways to decrease the scope without affecting the quality.

Even though, on occasion, there are CTMS projects where other implementation/integration partners are chosen by the client because of unrealistic proposed timelines, it is important to remember that success at the end of the project is what sets the foundation for solid, long lasting relationships. It may seem easiest to deal with delays after projects are signed, but this is certainly not a win-win situation for any party involved. So, develop realistic estimates from the very start and you will be on the right track to success.

At Perficient, we pride ourselves for establishing a good sense of trust with our clients based on proven successes, and adhere to our core values of Honesty and Integrity. For more information about our solutions related to clinical trial management systems, please contact us.

Follow Perficient’s Life Sciences blog on Twitter via @Perficient_LS.

Follow Perficient on LinkedIn here.