Custom Clinical Trial Management System

Clinical Trial Management Software at a Glance

A clinical trial management system (CTMS) is needed to efficiently manage trial data, study protocols, patient recruitment and enrollment, budgeting, study progress tracking, regulatory compliance adherence, and other related workflows.

Custom CTMSs may feature capabilities specific to certain trial domains (e.g., cardiac events prediction for cardiology, automated calculation of Kaplan-Meier curves for oncology). They also have enhanced integration and scalability capacity, which makes them an attractive option for organizations with complex trial portfolios.

Common integrations for a CTMS: EHR/EMR, HIS, RIS, LIS, ERP, a payment system, a barcode system, a remote patient monitoring system.
Implementation time: 6 to 18+ months.
Development costs: $50,000–$500,000+. Use our free calculator to estimate the cost for your case.

Sample Architecture of a Clinical Trial Management System

A CTMS can be integrated with a variety of data sources (EHR/EMR, LIS, ERP, and more) for instant access to all the necessary information, including patient data, staff schedules, supplies and equipment availability, finances, and more. A connected electronic data capture system (EDC) is used to streamline clinical trial data collection and management.

The CTMS back end processes and stores the consolidated data in a structured format that is ready for analytics (e.g., in a data warehouse). An analytics engine processes user requests and sends the required information (e.g., data views, scheduled and ad hoc reports, AI output) to the main user interface.

A patient portal enhances patient engagement and retention by giving patients instant access to study-related information, schedules, and updates.

The data governance framework includes mechanisms for data backup, encryption, multi-factor authentication, role-based access, data anonymization, and more. These measures are meant to ensure data quality, integrity, security, and privacy in accordance with the relevant regulations such as HIPAA.

Key CTMS Functionality

Study planning

Template-based protocol creation using pre-built fields (e.g., for study objectives, eligibility criteria, endpoints).
A version control system to ensure all entities work on the latest protocol version.
Budget estimation based on historical and current data on study procedures, participant compensation, laboratory tests, site fees, and other study aspects.
Tools for efficient personnel, equipment, and materials allocation.

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Project management

Trial timeline and milestone tracking.
Tools for allocating personnel, equipment, facilities, supplies, and other resources required for the trial; automatically identifying deficiencies and re-allocating resources.
User-defined criteria and algorithms for trial risk detection and assessment. Instant alerts on emerging risks to trial managers.

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Site management

Access to study site databases (e.g., ClinicalTrials.gov and CTSU in the US, the EU Clinical Trials Register and ECRIN in the EU).
Automated site evaluation against the required criteria (e.g., patient demographics, staff qualifications, available infrastructure).
Continuous site performance monitoring (e.g., enrollment rates, adherence to protocol, and regulatory compliance)

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Financial management

Monitoring the trial budget and expenditures, including travel and supplies.
Managing payments to trial sites, investigators, and vendors.
Handling grants and funding allocations.
Alerts on current or forecasted budget deviations.

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Subject management

Matching potential trial participants against the predefined inclusion and exclusion criteria.
Informed consent collection through electronic signatures.
Scheduling visits and sending reminders about upcoming appointments to patients.
Managing electronic consent forms.

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Collaboration

Assigning tasks to team members (e.g., investigators, CRCs, nurses) and tracking task completion.
Secure messaging and document sharing between sites and study teams.
Integration with email, calendar, collaboration tools.

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Analytics and reporting

Historical and real-time reports with insights into study progress and performance.
Site performance benchmarking against historical trials and industry standards.
Predictive analytics (e.g., to forecast enrollment rates, possible adverse effects).
ML/AI-powered medical image analysis (e.g., for MRI, CT scans).
Ad hoc report creation and data querying.

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Quality assurance and control

Centralized document repository with version control and audit trails.
Automated checks and alerts on upcoming regulatory deadlines, required documentation updates, potential compliance issues, protocol deviations.

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Security and data privacy

Access controls (user authentication, access rights, action permissions, automatic logoff, etc.).
End-to-end data encryption and anonymization.
Compliance with global data protection regulations (e.g., HIPAA, GDPR) and industry standards (e.g., 21 CFR Part 11).
Data exchange according to HL7, FHIR, DICOM standards.

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Patient portals

Online access to trial information (e.g., study procedures, ePRO forms).
Direct communication with study teams via secure messaging and video calls.
Automated notifications and reminders on upcoming events and activities for patients.

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How to Develop a Clinical Trial Management System

Clinical trial management system software development allows research companies to get a tailored solution for effective management of their study process, sites, subjects, budget, and more. Below, ScienceSoft outlines the key stages of building custom clinical trial management system software:

Requirements engineering

Business analysts conduct interviews with researchers, clinical trial coordinators, sponsors, and other stakeholders to understand the workflows involved in clinical trial management, including data collection, patient recruitment, and regulatory submissions. Based on the acquired information, they define functional and non-functional requirements for the software-to-be, including software capabilities, essential integrations, and security and compliance requirements (e.g., FDA 21 CFR Part 11, HIPAA, GDPR).

Software design

At this stage, software architects decide on architecture components, tools, and techs that would support the workflows defined during business analysis. This can include choosing optimal public-available APIs or developing custom ones to ensure integration with the required systems; deciding on mechanisms for data format standardization and real-time data synchronization. This step also includes elaborating security controls and data management procedures.

UX and UI design

Designers identify role-specific user journeys and build tailored UIs to support their unique workflows. For example, clinical trial coordinators will benefit from a dashboard that prioritizes patient recruitment metrics, visit scheduling, and compliance alerts to optimize the processes of study progress monitoring and participant management.

Development and testing

Arranging development in parallel with testing helps identify and prevent potential issues early, optimize collaboration between development and QA teams, and avoid severe defects in production. Other best practices for optimizing the development process and costs include implementing CI/CD pipelines and DevOps practices, implementing QA automation, and utilizing proven third-party components and microservices (e.g., for data storage components, data management tools). In ScienceSoft’s experience, this approach can help reduce development costs by up to 78%.

Deployment and support

The solution is integrated with the necessary data sources (EHR, LIS, ERP, etc.) and monitored to identify any remaining flaws and promptly implement the necessary improvements (e.g., enhance compatibility between different data formats). Comprehensive software documentation (e.g., configuration and maintenance guides and instructions on API usage) is created to support smooth software deployment, maintenance, and evolution. At ScienceSoft, we also provide one-month post-launch warranty when we fix major software issues free of charge.

Technologies ScienceSoft Uses for CTMS Development

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Clinical Trial Management System Costs

The cost of development for a custom clinical trial management system can vary from $50,000 to $500,000+, depending on software complexity. A custom CTMS can bring a 4-year ROI of up to 270%. The ROI drivers include automation features (e.g., data capture, patient recruitment) that lead to accelerated trial completion, reduced errors and administrative costs. When determining the cost of a custom CTMS, ScienceSoft considers such factors as the number and complexity of integrations, the scope of trial management workflows, the need for real-time data processing and ML/AI-powered capabilities, and more.

$50,000–$150,000

A basic solution that:

Features core capabilities (e.g., automated electronic data capture, patient enrollment tracking, study planning and progress monitoring, site and resource management).
Integrates with up to 3 systems (e.g., EMR, ERP, barcode system).
Offers core analytics capabilities (e.g., historical insights like patient demographics and dropout rates).

$150,000–$500,000+

An advanced solution that:

Features advanced capabilities (e.g., real-time risk monitoring, built-in payments).
Integrates with all the required data sources, including legacy and custom systems.
Offers advanced analytics capabilities, including those powered by ML/AI algorithms (e.g., adverse events prediction, recommendations to optimize resource allocation).

Off-the-Shelf vs. Custom Clinical Trial Management Software

There is a wide range of market-available clinical trial management systems that differ in functional scope and complexity, integration capacity, and pricing. None of them is a universal solution, so the preferred tool should be chosen based on the organization’s specific needs. In some cases, custom development will be more feasible. For instance, OOTB solutions may fail to provide sufficient storage and processing capacity for especially data-heavy trials (e.g., genomic research, tracking longitudinal data trends). A custom solution can also be an optimal choice for organizations that carry out multiple trials over extended periods of time: avoiding software subscription fees often leads to substantial cost savings in the long run.

Below, our experts provide a comparison of features and relevant investments for popular market-available software and a custom-built solution.

	Clinevo	SimpleTrials	Medidata	Custom
Basic trial management capabilities ? Automated electronic data capture, patient enrollment tracking, study planning and progress monitoring, site and resource management
Features specific to medical specialties and trial types (e.g., Oncology, Cardiology).				Any required specialty-specific features (e.g., disease-specific protocol templates and adverse event reporting tools).
AI-powered capabilities			AI features (pattern recognition and risk prediction) are available upon subscription to a dedicated Medidata product.	AI/ML capabilities of any complexity, including virtual assistants, medical image analysis, predictive analytics, and more.
Platform	Web, iOS, Android	Web	Web	Any (web, iOS, Android)
Ease of use ? Based on ScienceSoft’s expert assessment. Main criteria: intuitive and customizable UX and UI, short learning curve.
Integrations	Native: with Clinevo eTMF and Training Management Systems.	Native integration with 8 EDCs (e.g., Castor, ClinCapture, IBM CD).	Native integration with Medidata EDC and Site Payments. API integration with third-party EDC, CTMS, eTMF, IxWR, and planning solutions.	Seamless integration with any required custom and platform-based solutions, including legacy software.
Compliance	21 CFR Part 11, EU GMP Annex 11, GxP, and GDPR.	21 CFR Part 11, SOC 2, PCI DSS.	HIPAA, GDPR, FDA, CFDA, MHRA, PMDA, SOC 2, PCI DSS.	Compliance with all required global and regional regulations.
Pricing (50 user accounts / 10 years)	Available upon request.	~$500,000-$600,000 for a plan that covers up to 100 studies and offers basic and advanced capabilities (site and document management, in-built payments, forecasting). NB: There are more affordable options (e.g., up to ~$115,000) with core capabilities and a limited number of users (up to 10).	Available upon request.	Up to $500,000+ for an unlimited number of users and studies. No additional fees.

What makes ScienceSoft different

We achieve project success no matter what

ScienceSoft does not pass off mere project administration for project management, which, unfortunately, often happens on the market. We practice real project management, achieving project success for our clients no matter what.

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