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5 Reasons Why You Shouldn't Build Your Own Risk-Based Monitoring Tools

With risk-based monitoring (RBM) gaining traction in the clinical trial industry, you may be wondering how best to implement an RBM program at your company. Many companies prefer to use RBM software provided by an outside vendor, such as Bioclinica's ClearSite. However, other companies may decide to build their own RBM software or tools in-house. I work closely with companies who have chosen to implement Compass, and I've also talked with companies who have gone the route of building their own RBM tools. Ultimately, building your own RBM tool can have some drawbacks that you may not have considered. Here are a few reasons why buying RBM software is a better choice than building it yourself.

1. You may not have enough resources to support your RBM needs

Often companies believe that their own team members will be the best people to create their RBM tools because they'll have the company's best interests in mind. However, does your team have the time to take on this project?

Building RBM tools can be a big undertaking with a lot of complexities involved. Your employees are likely already fully utilized, which means that they may not have enough time to devote to a side project. Your team may only have a couple of hours a week to work on this RBM initiative. If you have a team of people trying to move an RBM tool forward and each person only has a few hours per week to devote to it (many of those hours not overlapping), it might take significantly more time before you have a usable solution to your RBM needs. There is also the potential that your team could spends too much time building RBM tools, which could negatively affect the rest of their work. Buying software from an outside vendor eliminates these problems because 100 percent of the vendor team's time is dedicated to identifying industry standards, creating that tool that meets those standards and making it readily available to you.

2. The long-term costs involved

Some companies go the route of building their own RBM tools due to sticker shock from software vendors. The upfront cost of buying RBM software can seem high, but make sure you're taking all the long-term costs of building RBM software into account as well when weighing your options.

As I mentioned earlier, time can be a long-term cost of building your own tools. Since your employees already have full-time jobs, it can take a long time before you're ready to go with your RBM program. Once the tool itself is complete, it also will take a lot of time to create the materials necessary to educate the rest of your organization on the new RBM process and tool—let alone actually go through the process of training the teams.

An upside of using a vendor such as Bioclinica is that we can help educate your team and train them on RBM and the software so you don't have to take the time and money to create and implement those resources yourself. We offer e-learning trainings and help guide our customers through the entire implementation process. If you were to build all of your own educational materials, it would cost additional time and resources that you may not have factored into your original decision.

3. Your team may not have the right skill set to build this tool

Your company may have the appropriate people for decision-making, but are they the right people to build an RBM system? RBM is still a relatively new concept, so your team may not fully understand the breadth of what is required to make a successful RBM tool. Your team may not have the right skill set to ensure that the final RBM product is the most efficient, documentable and user-friendly for your end users. Additionally, if you are building the tool yourself, the process can become siloed because you will only get ideas and guidance from one perspective—that of your own company.

Although RBM is still “green” in the industry, our entire team at Bioclinica has experience in RBM. As long as RBM has been an FDA guidance—and even before it was a finalized guidance—many of us have been working in RBM. We understand all the complexities and considerations necessary to create truly effective and powerful RBM software—knowledge that your in-house team might not necessarily have.

Another benefit of using a vendor versus building it yourself is that you can learn from other companies' experiences instead of solely relying on your own. There's a huge educational opportunity that comes from working with a vendor because you can get their insights into successes and failures they've experienced while implementing RBM. We have worked with so many different pharmas, CROs and medical device companies who were not only implementing Compass, but implementing RBM as a process, which means we have a lot of experience and lessons learned we can bring to the table. Our clients have told us that our non-company-specific perspective and advice based on potential issues we've seen with other clients has been one of the most helpful parts of working with us.

4. Your team may not be prepared to handle advancements in RBM

Another potential long-term impact of building your RBM tools need to be continually improved to meet the latest industry standards. Often companies get their homegrown tools to a certain point, but as the industry advances in RBM, the homegrown system can't keep up. Your RBM tool will have to be continuously updated, otherwise you could be working with an outdated tool. Sometimes companies don't realize that this could be too much for a team with limited time on their hands. They also may not realize the financial implications of continuously updating the tool on their own.

For example, consider the recent revision to the ICH Guideline for Good Clinical Practice (E6 R2), which sets the expectation that companies should be using RBM and having the proper documentation. Since our team at Bioclinica is 100 percent devoted to ensuring the quality of our Compass tool, we are constantly looking out for such changes and updating Compass accordingly. An in-house team with other responsibilities may not have the time to devote to tracking these new regulatory updates and how it impacts your RBM system since working on the tool isn't their full-time job.

5. You may not be thinking ahead for other studies

Often when companies build their own RBM tools, they're focusing on one particular study. Most companies will set up their tool to look at one static moment, make a decision and move to the next static moment. If you work at a company with 50 studies, you may not be able to see the bigger picture of how those studies are working in comparison to one another because they're being evaluated individually. Software like Compass can give visibility into how all your studies are performing so you can get a pulse on how your clinical organization is working in addition to looking at individual study performance.

With all of the factors that go into a successful RBM program, choosing to buy RBM software rather than build it yourself is a smart move. If you'd like to learn more about the benefits of implementing a solution such as ClearSite, feel free to send us a message.

RBM 101: What is Risk-Based Monitoring?

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