A Clinical Trial Management System (CTMS) is a software system that manages and organizes tasks and processes related to clinical trials. General CTMS features include complete management & maintenance for the functions of performance, planning, and reporting.
A Unified Clinical Trial Management System is a solution that offers a CTMS software which can single-handedly manage the entire clinical study process with real-time visibility and analytics across study planning, budgeting, start up, study management, and close out.
A unified CTMS is aimed at keeping track of every relevant part of your trials and involves integrating a long list of functionalities into your CTMS solution. It helps to securely store (often in the cloud) and easily sort your clinical studies’ documents for improved access and retrieval, manage your sites, keep track of participant enrollment, chart information visually to remind relevant stakeholders of important milestones, generate site visit reports, get timely notifications (messages, emails, mobile notification) for anything relevant ( inventory shortages, budgetary changes, and more). All using unified CTMS software.
Now that we’ve covered what unified clinical trial management systems are, let’s examine why unified CTMS solutions matter.
While all CTMS solutions offer greater reduction in the number of redundant tasks which fall upon trained clinical personnel to perform across different solutions. For e.g. If your Delegation of Authority (DoA) Log is unified with the electronic site binder and Trial Master File (TMF), the research staff only need to complete this log at one place and everything else is taken care of by a unified CTMS automatically or with just a click of a button.
Unified CTMS solutions in particular offer other valuable insights that may not be available in all CTMS solutions, such as site metrics, dashboards which summarize the information you need to monitor most frequently, as well as more extensive reporting options. Other reasons that unified clinical trial management systems matter include saving time, money, and effort, which is particularly important in job markets where there’s a shortage of major talent.
A truly unified clinical trial management system will streamline trial planning, conduct, and management processes to optimize workflow outcomes determined by better information. The use of any appropriate CTMS solution can spare a relevant organization a lot of extra work. Manual and semi-manual administrative record keeping also multiplied sources of information in the past due to duplicate records, leaving room for significant miscommunication. Utilizing a unified CTMS allows for the consolidation of all records to one single source of information.
Now the most fascinating part. How? Quite simply, putting everything in the same place is enormously convenient and efficient.
Since they came out, not all unified clinical trial management systems have been able to keep up with the rapidly changing demands of the industry. CTMS solutions that might have been great 5 years ago, or even 2 years ago, may be outdated now in 2022.
A general principle from when the idea of unified CTMS was conceived is to focus on process-driven solutions. Process-driven unified CTMS solutions are more likely to keep up with industry demands in the future. There are protocol-focused solutions which leave no room for flexibility for processes. Those solutions are more likely to stagnate in the future, even if they’re on the cutting edge when first developed.
Remember to make sure your unified CTMS solution actually is “unified”. A unified solution has one log-in and seamless experience rather than a disconnected process. You should not only manually go through a list of all its integrated functionalities unified into one place, but also make sure your vendor offers the level of customization you need for those functionalities.
Your unified CTMS solution can be cost-efficient, scalable, and rapid-to-deploy as well as being highly customizable. You needn’t settle for less customizable options because you think you won’t find a solution you can both deploy quickly and not break the bank on. Ask for demos from various vendors on the level of customization you need and make comparisons.
The reason demos are important is because a unified CTMS solution could present as highly integrated in theory, but without looking at it, you can never be sure.
To that end, these are the four basic contributors that apply to any new CTMS evaluation:
Facilitation of Teamwork: All personnel involved with a trial, such as investigators from participating sites, should be able to access the CTMS in addition to sponsors and CROs. Looking at cloud based CTMS solutions makes that level of access easier to implement.
Regulatory Compliance: Depending on the jurisdiction you operate from, your CTMS needs to be compliant with all the requirements and conditions set forth by the relevant regulatory authorities.
Financial Control: Your CTMS solution should offer the option to integrate a financial management component into the system, to consolidate any budget and payment tracking in a singular location..
Reporting Capabilities: Your CTMS should be evaluated as to whether it offers the criteria necessary for real-time reporting. The reporting capabilities of your CTMS should be evaluated for Business Intelligence, which consolidates the segregated data or information stored in your CTMS to offer integrated visualization presentations, which can illuminate potential improvements to your organization’s existing processes, from budget negotiation to trial efficiency.
Unified CTMS solutions seamlessly integrate all the functionalities required for a clinical study from planning to closeout. This integration is advantageous for oversight and regulation, money, time, and labor.
Cost-efficiency need not be a compromise if it comes along with the right features and configuration. Now we can safely say we answered the three questions we set out to answer- What unified clinical trial management systems are, why they matter, and how to choose them.
Author: Reeshav Mittal, BDS, CCRA, CCRP, Associate Director, Clinical Operations, Cloudbyz