What is clinical trial management system software, and do I need it?

In the fast paced world of clinical research, managing the detail of a clinical trial can be a daunting task. This is where clinical trial management software (CTMS) comes into play. CTMS can revolutionise the way trials are conducted and managed. 

These cutting-edge tools streamline every aspect of a clinical trial from planning and recruitment to data collection and reporting, by integrating trial-related activity into one seamless platform. This blog explains how CTMS can help you manage your trial more efficiently and provide you with some software solutions.

Do I need clinical trial management system software?

Determining whether you need CTMS depends on the specific requirements and scale of your clinical trial. While CTMS offers comprehensive tools for managing complex, large-scale trials, smaller and less complex trials may not require such extensive systems. 

Here are some considerations to help you determine if a CTMS is necessary for your trial:

• Large-scale trials: If your trial involves multiple sites, a large number of participants, and a significant amount of data, CTMS can help streamline operations and manage the complexity.
• Multi-centre trials: For trials conducted across multiple locations, CTMS provides centralised management, ensuring consistency and coordination among sites.
• Complex protocols: Trials with complex protocols, multiple arms, and extensive data collection requirements benefit from the structured management and data integration capabilities of CTMS.
• Regulatory compliance: CTMS helps ensure compliance with regulatory requirements (e.g. TGA, Good Clinical Practice, 21 CFR Part 11) by providing audit trails, document management, and secure data handling.
• Financial management: If your trial involves significant financial transactions, such as site payments and budget tracking, CTMS can provide tools for efficient financial management.
• Data integration and reporting: CTMS allows integration with Electronic Data Capture (EDC) systems, Laboratory Information Management Systems (LIMS), and other tools, facilitating comprehensive data management and reporting.
• Project management: For trials requiring detailed project management, CTMS offers tools for timeline tracking, resource allocation, and monitoring progress.

Considerations when choosing CTMS for your clinical trial

Selecting the right CTMS for your clinical trial involves considering various factors to ensure the software meets your specific needs and complies with regulatory requirements. There are important factors to consider when it comes to choosing a CTMS that can keep up with the ever-changing environment of clinical trials and research. 

• Usability: The software should have an intuitive and user-friendly interface to ensure ease of use,  particularly for sites that are adopting CTMS for the first time.
• Accessibility: The ability to access a CTMS platform from any research site is an important consideration. Web-based CTMS solutions provide a solution to this and can enhance collaboration across the team.
• Integration capabilities: Ensure the CTMS can integrate with other systems you use, such as EDC, LIMS, EHR, and regulatory submission systems. APIs and other integration tools can also facilitate data exchange and streamline workflows.
• Value for money: The cost of CTMS solutions can vary significantly. It is important to make sure that the features address the needs of the trial and to consider the level of support offered, including technical support, user training, and customer service.

What CTMS options are available? 

The list below includes 10 of the best CTMS options designed to streamline, speed up, and improve the decision-making process of clinical trials and research operations.

Medidata Rave CTMS

• Features: Comprehensive clinical trial management, site and subject management, financial tracking, and regulatory compliance.
• Advantages: Integrates seamlessly with Medidata’s suite of clinical trial solutions, robust data management, and strong support.

Veeva Systems CTMS

• Features: Cloud-based platform with study planning, site monitoring, document management, and real-time reporting.
• Advantages: User-friendly interface, integration with Veeva Vault for document management, and scalability for large trials.

Oracle Health Sciences CTMS

• Features: Extensive functionality for study management, site and subject tracking, financial management, and analytics.
• Advantages: Strong integration capabilities with other Oracle Health Sciences applications, robust security, and compliance features.

BioClinica CTMS

• Features: Study setup and planning, site management, subject tracking, financial management, and comprehensive reporting.
• Advantages: Strong focus on user experience, flexible customisation options, and good integration with EDC and other systems.

TrialKit

• Features: Mobile-first CTMS with EDC, ePRO, eConsent, and patient engagement tools.
• Advantages: Easy to use, mobile accessibility, and suitable for decentralised trials.

MasterControl Clinical Excellence

• Features: Document management, quality management, trial management, and compliance tracking.
• Advantages: Strong focus on regulatory compliance, integrated quality management, and robust reporting tools.

encapsia

• Features: Document management and monitoring, medical coding, API integration, and e Source. 
• Advantages: Supports decentralised clinical trials, captures data offline, real-time data syncing, good integration with other systems.

MainEDC

• Features: Risk based monitoring, advanced API, audit and inspections QA support, central and local laboratory data handling. 
• Advantages: Offers fully integrated tools, including EDC, Interactive Web Response System (IWRS), drug and supply management, and electronic Patient Reported Outcome (ePro).

EDGE

• Features: Patient management and recruitment, real-time workflow process capture, finance recording and reporting.
• Advantages: Designed to eliminate task overlaps and efforts and ensure the integrity and protection of patient data, customisable fields and shared calendars.

VISION

• Features: DIY EDC builder, on-demand reporting, auto data cleaning, site initiation and recruitment, aggregated study metrics.
• Advantages: It offers three solutions (Study Builder, ePRO, and Study Startup) that enable users to create a personalised EDC, collect clinical data, and manage clinical trials remotely.

My Clinical Trial Planner by HTQ

My Clinical Trial Planner is a helpful resource that can support your trial progress and compliment your CTMS. Providing resources and information at every step of your trial, My Clinical Trial Planner can help you maximise your efficiency and ensure each step of your trial is completed to the highest standard. It’s free, and you can share your progress with members of your team. Try it today!

FAQs about clinical trial management systems

What is a clinical trial management system (CTMS)?

A CTMS is a software system designed to manage the planning, tracking, and reporting of clinical trials. It helps streamline and centralise the management of clinical trial activities, including study setup, participant recruitment, site management, regulatory compliance, and data management.

What are the benefits of using a CTMS?

A CTMS improves efficiency, enhances data accuracy, ensures regulatory compliance, and provides centralised oversight for all trial activities. It simplifies complex trial processes, reduces manual errors, facilitates communication among stakeholders, and helps manage multiple trials concurrently.

What features should I look for in a CTMS?

Key features to look for include:

• study planning and setup
• participant recruitment and enrollment tracking
• site management and monitoring
• regulatory compliance management
• financial management (budgeting, payments)
• document management
• data integration with EDC, LIMS, and EHR systems
• real-time reporting and analytics
• user-friendly interface and role-based access control.

Is CTMS necessary for small-scale or single-site trials?

While CTMS is advantageous for large-scale and multi-site trials, small-scale or single-site trials might not require a full-featured CTMS. However, even for smaller trials, a CTMS can provide organisational benefits and improve data management and regulatory compliance.

How does a CTMS ensure regulatory compliance?

CTMS ensures regulatory compliance by providing audit trails, maintaining version control for documents, offering secure data storage, and facilitating adherence to guidelines like GCP, FDA 21 CFR Part 11, and TGA regulations. It helps manage and document all compliance-related activities.

Can CTMS integrate with other systems we use?

Yes, most modern CTMS solutions offer integration capabilities with other systems, such as Electronic Data Capture (EDC) systems, Laboratory Information Management Systems (LIMS), Electronic Health Records (EHR), and financial systems. This integration ensures seamless data flow and reduces duplication of efforts.

How is data security managed in a CTMS?

Data security in a CTMS is managed through various measures such as data encryption, secure access controls, regular security audits, and compliance with data protection regulations such as the Australian Privacy Principles (APPs). Additionally, most CTMS solutions provide detailed audit logs and role-based access to ensure data integrity and confidentiality.

What are the costs associated with implementing a CTMS?

Costs vary based on the size and complexity of the system, the number of users, and the specific features required. Costs may include licensing fees, implementation and customisation costs, training, and ongoing maintenance and support fees. 

How long does it take to implement a CTMS?

The implementation timeline can vary widely depending on the complexity of the system, the readiness of your organisation, and the level of customisation required. Implementation can take anywhere from a few weeks to several months. A phased approach is often recommended to manage the transition smoothly.

What kind of training and support is available for CTMS users?

Most CTMS vendors offer comprehensive training and support, including online tutorials, webinars, user manuals, and in-person training sessions. Support can include technical assistance, customer service, and ongoing maintenance to ensure the system operates effectively and users are comfortable with its features.

How does a CTMS handle document management?

A CTMS typically includes a document management system (DMS) that allows for secure storage, version control, and tracking of essential trial documents. It enables users to manage regulatory documents, SOPs, trial master files, and other critical documentation efficiently and ensures compliance with regulatory requirements.

Can a CTMS be customised to fit specific trial needs?

Yes, many CTMS solutions offer customisation options to tailor the system to specific trial needs. This can include custom workflows, specific data fields, tailored reporting formats, and integration with other systems. Customisation ensures that the CTMS aligns closely with operational processes and regulatory requirements.