Managing a clinical trial is no small feat. Documents must be tracked, client sites monitored, notes and findings to review, a robust Trial Master File (TMF) to manage and reports to prepare. When you’re working across disparate systems, all the moving pieces of a successful clinical trial can seem daunting to manage. This is why clinical trial management systems (CTMS) were created — to increase operational efficiency, reduce complexity, and provide a platform to manage a trial from startup to closeout.
If you research online, you’ll find vendors from across the globe with promises of seamless trial management, stunning visualizations, and easy-to-access data. How do you know if they are selling an actual product or a vision? Do you really need all those features within your CTMS system? That’s what we are here to uncover.
Understanding the Basics of CTMS
Starting at the basics, a CTMS platform is a system that manages the planning, management, and intricacies of clinical trials — the foundation for managing effective clinical trials. At it’s core a CTMS needs to do the following:
- General Clinical Trial Management – supporting the key aspects of a clinical trial including calendars, resources, communication, submissions, and activities
- Documentation – this must align with two fronts, maintaining the eTMF system for study documents and tracking forms, approvals, and case files
- Financial Tracking – budget management and payment acceptance is a key feature along with the ability to track for disclosures
- Site Management – Monitoring of sites and protocols for clinical trials to ensure sites are aware of responsibilities between site visits
- Operational Insights – ability to align stakeholders and sponsors with issue tracking and dashboards
- Risk Management – planning for and tracking of deviations within a trial to coordinate responses that mitigate potential risks quickly and easily
Each of these aspects are core items that clinical teams need to manage from start to completion of clinical trials.
A CTMS system that supports the basics can mean a drastic difference in the success of clinical trials, and with 90% of drugs not moving past the clinical stage, organizations can use any advantage to get a drug or therapy to market. The failure of making it to the market notwithstanding, a CTMS is a distinct advantage to organizations because it centralizes information that needs to be kept and can support the execution of Good Clinical Practice, ensuring that an organization does everything possible to coordinate success.
What More Should a CTMS Include?
Covering the basics of a CTMS is a great start, but it’s just that — the basics. It’s important to determine what elements your CTMS should have to enable success at your organization. Whatever CTMS you select for your organization needs to align with your own goals, short-term and beyond. Here’s some things to consider:
Every organization utilizes a variety of software day-to-day and whatever system you select, it should be one that integrates easily with your current systems. With over 50% of organizations citing that it’s difficult to integrate their software, it’s essential to find one that eases the burden on your IT infrastructure and clinical team.
Tasks that are redundant can be easily automated and should be. A CTMS solution should automate repeatable tasks and streamline study operations, freeing your clinical team to utilize their talent where it matters most. Automation decreases human error and increases accuracy to limit potential findings in your clinical trial.
Ensuring that your CTMS system is in line with industry standards is crucial, especially related to 21 CFR Part 11, and should cover audit trails, e-signature, user controls and data archival following trail completion
Organizations grow and their software should do the same. When selecting a CTMS, organizations should consider the long-term usage of the system and find a solution and partner that will grow alongside it.
Every organization has some level of unique needs and finding a solution that can adapt to your processes should be considered when buying a CTMS. While certain items are great off the shelf, finding a CTMS that can be tailored to what you need can increase time to value and strengthen your organization.
Each of these features should be considered when purchasing an CTMS solution and are an advantage to any organization. But why consider a CTMS?
The Benefits of a CTMS
Why should you consider a CTMS? What advantages does it have over what your organization is doing right now whether it be outsourcing to a CRO or leveraging a homegrown solution? There comes a point that as an organization scales, adopting a CTMS makes sense. The risks associated with lost trial visibility or human error quantify and become just too risky.
- Increased Efficiency
Up to date information and modern workflows can reduce the amount of time it takes to complete tasks and as a result, organizations become more efficient. Organizations have seen a 30% decrease in time when utilizing a CTMS over traditional systems.
- Faster Searching
Documentation is an essential part of clinical trials and researchers need to find things fast. A CTMS can decrease the time it takes to find a document via metadata and search capabilities. When you can find the document faster, you can move onto the next task with ease.
- Better Transparency and Collaboration
A system that is accessible and up to date ensures that organizations can monitor sites as needed. This means that organizations can provide the oversight needed to sponsor whenever needed and enhance collaboration between parties.
- Streamlined Processes
Driving further efficiency, a CTMS can streamline processes allowing others to learn the system faster and spend less time in the system.
- Detects Problems Quickly
Risk is something that every organization wants to manage but when it comes to clinical trials, it’s essential. Having a CTMS with risk planning built in helps dramatically. Also, a single source of truth in a CTMS allows organizations to locate related information to act quickly and keep the trial on track.
These benefits just scratch the surface of what a CTMS can do for an organization but are each a significant advantage. For additional information on what you should evaluate when selecting a new CTMS solution, download this checklist to evaluate new systems as you’re speaking with potential vendors. If you’re ready to begin your CTMS buying journey, consider learning more about LifeSphere CTMS and chat with us today.