10 Ways a CTMS Can Transform Your Trial Management

Regardless of how many years of experience in clinical development you might have, your age, your technical expertise, the role you play in study management or even the number of studies or sites involved in your program, a CTMS can always continue to significantly transform your trial management. And we all know how important statistical significance is when trying to get our products approved by the regulatory authorities! Here are 10 ways that a CTMS solution can transform your clinical trial management workflows.  

Aggregation!

The core of a clinical program is data; “Show me the data, show me the proof” is always required in our regulated industry. We have SO much data in SO MANY disparate places that it can be overwhelming to centralize it. Since most sponsors and CROs rely on trackers to collect this data, it can be challenging to get the right information when you want it. HINT: everyone ALWAYS wants it in real time. 

The CTMS is critical for efficient trial management, as it allows for data aggregation in a database organized into different buckets of information, empowering your organization to make better decisions, quicker. All your data is in one place and can be retrieved. 

Central Vendors

Most sponsors and CROs have central vendors which they use for trial execution. These providers typically have their own “portal” or login process to view and download data. A CTMS that allows you to set up other central vendors with single sign-on access can eliminate the need to remember multiple passwords for data retrieval and documentation. This can save a lot of time and prevent headaches when sharing key information with management personnel! 

Mobile Access

Ever since pandemic-era travel restrictions were relaxed, people seem to be more on the move than 4+ years ago. These days, you need key study information at your fingertips, as you never know when you will get a call or a text from your manager asking about patient or site enrollment, site activation, etc. At times, you may not have your laptop handy or worse, discover that your battery has died! Most of the world now has mobile devices that they carry everywhere, either iOS or Android - where they may get that text from their boss. These devices’ battery life is much longer than that of a laptop. 

CRAs on the road to visit investigative sites and study managers juggling work/life balance love a CTMS that comes with a mobile app where they can access their study on the go without the need to flip open their laptop. Global users also appreciate language localization preferences and can get directions to their site within the CTMS app. Efficiency and productivity for the win! 

Milestones

Milestones are to be celebrated but to celebrate, sponsors first need to define the milestones for the study to track, update, and achieve them. As a former study manager for both sponsors and CROs, one of our big milestones was always FIRST PATIENT IN. That notified the management and investors that we were moving. We passed the first enrollment milestone, celebrated our success, and looked up the road to the next milestone. Setting up milestones in a CTMS allows teams to visualize what is upcoming, which milestones are past due (and update for new realistic dates) and get the satisfaction of seeing that progress is being made. Tough to do on an Excel tracker… 

Study Patients

A quick view of patient enrollment in a study is critical - this data can come from an EDC or IxR system. Regardless of the system, sponsors want to know in real time when a patient is enrolled, their patient status and ultimately when they can stop recruitment/when the last patient visit has occurred. Leveraging a CTMS as an aggregator can transform trial management by providing close to real-time updates on patient status with data integrated from EDC, rather than going to a different system to view the information. 

Protocol Deviations

The FDA and ICH require tracking of protocol deviations and classification as important or non-important. Many sponsors will keep these in trackers or other systems that are not centralized. A CTMS allows all deviations to be centralized, owners defined, and once classified, routed to relevant team members to review and sign off on. This can identify trends and triggers that would not be possible without a CTMS.  

Visit Report Documentation

In regulated industries if it wasn’t documented it didn’t happen! The FDA and other regulatory agencies require documentation for visits to investigative sites to oversee the study activities . Some companies still use Microsoft Word documents or outdated, homegrown management systems to generate visit documentation. However, this makes it virtually impossible to identify trends and compare data from previous visits (believe me…I worked with such poor systems years ago). 

Implementing a modern CTMS allows CRAs to put key information into the CTMS and once all relevant information is completed, PRESTO! The report is generated! This streamlines work for CRAs who can see open activities from previous visits, view status of protocol deviations, and generate a report. Additionally, once a report (along with the confirmation and follow-up letter) is completed within the CTMS, the approved version is seamlessly filed in the eTMF under the correct site in the right folder, reducing your risk of inspection findings. CRAs can now complete their documentation in the way that works best for them– a desktop computer (what is that?), a laptop or phone (iOS or Android)! 

Resourcing

It can be a challenge to determine allocations for sponsors and CROs. Many sponsors involved in Trial Management until recently were not familiar with FTEs and what they entail for a study. all CROs have an understanding, as how you allocate staff to a study is critical to how they run their business. 

A modern CTMS allows users to look at resourcing broadly, beyond study teams. Sponsors, CROs and study teams select (or don’t select) a variety of vendor partners for study execution including central labs, central IRBs, IP supply providers and many others. In a typical multicenter study, you may have CRAs that are partially allocated between 4 sites: say 30% in one, 20% in another and 50% in a 3rd. A good CTMS will allow sponsors the ability to assign Study Team members and percentage allocations in a manner that provides visibility across the study.  

Dashboards and Visualization

Many think a CTMS is only great for clinical teams. However, if used properly, a CTMS can be the “hub” of information for departments and management who are responsible for oversight and execution of development of an asset, in both pre-clinical & clinical development.  

Managers and senior management need information at their fingertips, such as status of all their studies, the number of sites active in a clinical trial, or the number of patients enrolled/completed. Sponsors, even if they outsource to a CRO, should consider implementing their own CTMS “light” so that select CTMS data can be integrated from the CRO giving real time information when it is needed on the go. This is the way many sponsors are starting to go instead of relying exclusively on CROs for their information. 

Email Reduction!

My colleagues know that there is nothing I hate more than Email. There are so many communication methods hitting anyone in the working world today: Email, text messages, WhatsApp, Microsoft teams, etc! Some of the older CTMS offerings would send off emails that only add to your inbox - less than ideal. A modern CTMS eliminates the need to email visit reports and letters (and all their versions) between CRA and managers, greatly streamlining notifications. The fact that you can view study status on a mobile device means no more emails like “hey can you tell me how many patients were enrolled this week?” or “how many sites are active now?” The modern CTMS reduces unnecessary emails so you can focus on the real work of getting your countries and sites activated, getting patients enrolled and completed and hopefully getting a positive result for your clinical studies! 

While I have highlighted 10 ways a CTMS can transform your Trial Management here, there are countless other benefits including reduced resource needs. If your company decides to roll out a CTMS/eTMF together, endless efficiency possibilities open up. eClinical providers that offer CTMS, eTMF and an entire platform designed to transform trial management developed BY CLINICAL, FOR CLINICAL will unlock endless opportunities for efficiencies as you journey through your successful clinical programs. Come talk to us at Trial Interactive so we can help assist and guide you on that journey!