Clinical trials help establish the safety and effectiveness of drugs or medical devices in patients. A Clinical Trial Management System (CTMS) is any software used to manage end-to-end clinical trial activities, including setup, preparation, conduct, monitoring, and closeout.
Improve trial efficiency through standardization, tracking, and data analytics.
As your organization grows, so does the complexity and number of trials, which entails sophisticated document, financial, and resource management. A CTMS provides user-friendly interfaces and one centralized repository for all study information, which reduces the need for data re-entry. Study teams can link the same information entered once to different milestones, risks, and tasks.
With customizable and insightful reporting, Clinical Operations can monitor key metrics (such as site enrollment status, patient enrollment, and completed subjects) to develop actionable insights. Furthermore, higher data visibility gives sponsors the real-time trial status, cutting down on avoidable delays in waiting for study team members or the CRO to provide critical information.
Many CTMS solutions can integrate with EDC, safety databases, and ePRO. As a web-based platform, a CTMS not only frees itself from physical constraints of storing large amounts of trial data, but also accelerates remote data entry, access, and processing.
Due to concurrent studies and numerous sites, oversight of all trials is a daunting task. CTMS feature workflow automation, which reduces human error and ensures continued, timely execution of trial processes. By standardizing workflows within the system, organizations can ensure that users consistently follow in-house guidelines, trial protocols, and the latest regulations.
There are numerous CTMS vendors in the life sciences space, all of which generally provide milestone tracking, workflow automation, and visual analytics. Below, we’ve listed some solutions that our clients use:
CTMS solutions are not one-size-fits-all. Determine which features are nice-to-have, and which ones are critical for your organization. For example, if a high degree of...
CTMS should be viewed as an investment. Licensing, system support, and subscription fees may be continuing costs that should be compared against your department’s budget. Consider how pricing...
Consider each vendor’s proposed implementation timeline against the time constraints of your company. If your first study site activation is in two months, narrow consideration down to...
Purchasing a CTMS is an investment not only of money, but also of time and effort. Regardless of organization size, it is a challenge to manage clinical trial data (a responsibility...
Does the CTMS software meets all requirements imposed by HIPAA, GDPR, and 21 CFR Part 11? Assess the vendor’s agility in releasing new features to support evolving regulations.
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