
August 28, 2025
Why MI Experts Can Reduce Operational Burden for Pharma Companies
Discover how partnering with MI experts at ProPharma can reduce operational burdens, enhance compliance, and improve efficiency for pharmaceutical companies.
In the evolving landscape of clinical trials, CTMS plays a pivotal role. It facilitates enhanced productivity, provides detailed insights from data, and upholds strict compliance standards, offering a holistic solution for trial management.
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.
A robust CTMS platform should support most of the following processes:
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...
Read MoreCTMS 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 customization and data migration tools are must-haves, confirm that potential vendors will support those needs.
Read LessCTMS 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...
Read MoreCTMS 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 may change as you add more studies and system users.
Read LessConsider 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...
Read MoreConsider 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 vendors who can complete the project in that timeframe.
Read LessPurchasing 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...
Read MorePurchasing 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 traditionally managed by CROs). How much training will your staff need to learn the system properly? Additionally, factor in your team’s adaptability and buy-in when selecting a particular solution.
Read LessDoes 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.
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.
Read LessProPharma's R&D Technology team understands the criticality of selecting the right CTMS and excels in aligning your companies’ needs with regulations and GxP system best practices. Our comprehensive approach and expert knowledge ensure that your organization is set up for long-term success. Our team has extensive experience in the following areas:
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Strategy & Business Process Optimization |
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If you are interested in implementing or optimizing CTMS, ProPharma's R&D Technology team comprises experienced consultants who can advise your digital transformation. If you are interested in partnering with ProPharma on any of the services above, contact us via the form below. We look forward to working with you!
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