clinical trial management system (CTMS)

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.

What is a Clinical Trial Management System (CTMS)?

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.

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Benefits of a CTMS

Improve trial efficiency through standardization, tracking, and data analytics.

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1. Increase Productivity

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.

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2. Enable Data-Driven Decisions

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.

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3. Enhance Transparency

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.

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4. Improve Compliance

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.

Key CTMS Capabilities

A robust CTMS platform should support most of the following processes:

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Study Planning & Oversight

Study Planning & Oversight

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Subject Recruitment

Subject Recruitment

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Site Monitoring

Site Monitoring

compliance

Risk & Issue Management

Risk & Issue Management

Study Planning & Oversight

  • Assess study milestones (ex: first patient in, last patient out) via user-friendly interface.
  • Reference operational data of historical trials in a centralized repository.
  • Send automatic notifications to CRAs when site visits are almost due.
Business professionals smiling at a desk reviewing data

Subject Recruitment

  • Plan subject recruitment at the study, study country, and site levels.
  • Analyze reports on patient recruitment and retention against predefined targets.
  • View subject enrollment in real-time.
Healthcare provider writing on clipboard while attending to a patient

Site Monitoring

  • Manage pre-study, site initiation, interim monitoring, and closeout activities remotely.
  • Develop operational metrics dashboard for onsite monitoring.
  • Trace protocol deviation creation, revision, and finalization via audit trails.
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Risk & Issue Management

  • Capture protocol deviations, issues, and follow-up items.
  • Implement risk assessments and mitigation.
  • Create reports to track KPIs and resolution turnaround time.
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Popular CTMS Systems

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:

  • Rave CTMS (Medidata, Dassault Systemes): End-to-end cloud-based platform featuring intelligent risk detection and bidirectional information transfer with Rave eTMF.
  • Siebel CTMS (Oracle): Trial management suite that improves data quality and risk analysis at both study and portfolio levels; can be integrated with advanced analytics capabilities.
  • Trial Interactive CTMS (TransPerfect): Mobile-first 360° platform that offers integrations with TI’s site feasibility, study start-up, eTMF, LMS, content management, and collaboration solutions.
  • Vault CTMS (Veeva Systems): Adopted by hundreds of organizations, Vault CTMS can consolidate with other applications in the Vault Clinical Operations Suite: EDC, Study Start Up, Payments, and Veeva Site Connect.

Our Approach to Clinical Trial Management Systems

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Business Requirements

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...

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Business Requirements

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 customization and data migration tools are must-haves, confirm that potential vendors will support those needs.

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decentralized-clinical-trials

Budget

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...

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Budget

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 may change as you add more studies and system users.

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Timeline

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...

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Timeline

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 vendors who can complete the project in that timeframe.

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Complexity

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...

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Complexity

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 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.

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Compliance

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.

Compliance

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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ProPharma: Your Organization’s Preferred Partner

ProPharma'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:

Service Category

How We Can Help

Strategy & Business Process Optimization

  • System Selection
  • Roadmap Development

Regulatory Operations

  • Staff Augmentation

Implementation Support

  • Project Management
  • Configuration
  • Data Governance and Migration
  • Controlled Document Creation (SOPs and Job Aids)
  • Training

Validation

  • Validation Coordination
  • User Acceptance Test Scripts

Managed Services

  • Release Management

Clinical Trial Management System Experts

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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