As clinical trials become more complex, the operational aspects of a clinical trial also become more difficult to manage. Centralized systems that help with trial oversight and management, such as a Clinical Trial Management System (CTMS), are critical for today’s studies, and we are seeing more and more organizations adopt CTMS. However, CTMS implementations can be challenging. CTMS systems are often left by the wayside and abandoned as shelfware due to lengthy and inefficient implementations that lose momentum.
Benefits of a CTMS
A CTMS defines and manages all operational activities and data that span the clinical trial process – deadlines and milestones, patient information, the protocol and regulatory information. A well-implemented, well-integrated CTMS can act as your single source of truth in a clinical trial, enabling better decision making.
With centralized insight into the operational workflow provided by a CTMS, you can easily detect milestones that are falling outside of the target range and maintain oversight of study budgets. Automated processes reduce the burden of operational management, and visualizations keep you up to date on progress. In addition, the use of a CTMS allows consistent management of studies being conducted on different EDC systems.
So, why are companies abandoning their CTMS? Poor implementations and less than desirable user interfaces have left behind a few persistent, preconceived notions about CTMS systems.
Barriers to CTMS Implementation
- A CTMS takes too long to implement
Most CTMS implementations take 5-6 months – or longer – often pulling people away from their regular jobs and reducing productivity. Your team’s time is your most valuable resource – one that can’t be wasted. And, these 5-6-month implementations not only consume a lot of time and resources but also cause a loss of momentum, often resulting in not having your CTMS ready for study start-up.
- It’s too expensive
In addition to lost productivity, the initial investment is typically high. So, implementing a CTMS usually represents a capital purchase across all studies. For many companies, particularly small to mid-sized companies, this is a risk. What if the chosen system doesn’t meet the needs of all your studies? Then you’ve just spent a lot of time and money on a limited-use tool.
- It isn’t necessary
A CTMS is often viewed as an unnecessary luxury. Unlike Electronic Data Capture (EDC) or Randomization & Trial Supply Management (RTSM), which are required for the conduct of clinical trials, many companies try to make do with various “cowboy” or homegrown CTMS solutions. Although, on the face of it, these solutions appear to save time and money, a disjointed system consumes excess resources and will be prone to errors, increasing the indirect cost.
A manual system can also be confusing. Which version is correct? What process do I use? Where is this system located? If you had a single source of truth for all your trial data, you’d save time, money and confusion!
- It’s just another system to learn
The #1 risk in every CTMS implementation is user adoption. With all the different systems required to manage a clinical trial, a CTMS becomes yet another interface to learn. Because it can often be viewed as an unnecessary tool (see #3), the learning process becomes a burden, and fewer people want to use the system.
- It’s too difficult to adapt to new studies
Many CTMS systems are not scalable, and once the large capital investment is made, companies are locked in to using the system, even if it’s not a good fit. Studies inevitably evolve, and different studies have different needs, so companies are wary of choosing a “one-size-fits-all” CTMS.
The Future of CTMS
Over the years of working with our customers to implement CTMS systems, we’ve identified a list of ideal attributes for an efficient, cost-effective, widely adopted CTMS:
- User friendly: To help user adoption, the CTMS should have an intuitive, familiar interface. Nearly everyone is comfortable with Microsoft Office. With an interface that looks and acts like Outlook, Excel, PowerPoint and Word, users can manage their data in a format they already know.
- Purpose-built CTMS functions and streamlined MS reporting: CTMS logic, permissions and workflow – those should be encapsulated within the product, but users shouldn’t have to force the CTMS to be their reporting tool as well. By allowing visualization outside of CTMS (e.g., in Office products better suited to it), you can keep the functions, and only those functions, that need to be inside the CTMS.
- Integrated: To be efficient, the CTMS should connect with your other study systems, such as EDC and eTMF. Integration eliminates the need to manually transfer data from one system to another.
- Rapid start-up: Sometimes you don’t have 5-6 months to devote to implementation. A rapid start solution – that may not be as custom as a traditional CTMS but still has all the functionality you need – can be implemented in weeks instead of months.
- Scalable: Study needs evolve over time, and the system needs to be able to evolve right along with it. With a flexible and agile system, as your needs grow, so can your CTMS.
- Variable pricing model: You should only have to pay for what you use. When pricing is based on the number of active studies and active users, you’re able to avoid a huge commitment up front. Then, you can increase the number of studies and users once you’ve determined the system is the right fit for your organization.
We’ll be the first to admit that delivering the ideal CTMS is no easy feat. We’ve spent years developing Bioclinica CTMS with our customers’ needs and requests in mind – leveraging lessons learned, best practices and out-of-the-box configuration to minimize the upfront investment while providing a user-friendly, adaptive, flexible, fully functioning solution. The CTMS deployment model dramatically reduces implementation timelines (to as little as only a few weeks) and mitigates the financial risk associated with a traditional CTMS – making it perfect for small and mid-sized companies. With Bioclinica CTMS, it’s now possible to deploy and get value from a CTMS in a single-study scenario and reduce the barriers for better decision making.