Clinical Trial Management System

A Clinical Trial Management System (CTMS) is a comprehensive software platform for managing and streamlining clinical trials. It helps research organizations and CROs (Contract Research Organizations) optimize operations, track progress, and ensure Compliance with global regulations, improving efficiency and outcomes.

Streamlined Study Design and Execution

As a clinical trial management software development company, we ensure your clinical study designs are intuitive and effective by leveraging automated resource allocation, real-time monitoring tools, and task prioritization. Our tailored approach eliminates bottlenecks and reduces delays while keeping your trial fully compliant with regulatory requirements for exceptional outcomes.

Enhanced Participant Engagement

We transform the participant experience by directly integrating tools like eConsent, ePRO, and automated reminders into your workflows. Through seamless mobile compatibility and centralized data handling, we empower researchers to collect real-time, accurate data while keeping participants actively involved.

Real-Time Insights for Smarter Decisions

Our clinical trial management system is designed to provide you with real-time insights through interactive dashboards and analytics. We equip you with role-based access, automated alerts, and customized reporting to ensure accurate, informed decision-making at every stage of the trial lifecycle.

Why Choose Us for Clinical Trial Management System Development?

  • Domain Expertise in Life Sciences:

    Leverage our deep understanding of clinical research and regulatory requirements for precise software solutions.
  • Tailored Solutions for Unique Needs:

    Get personalized software development to meet your research organisation's or CRO's distinct requirements.
  • Advanced Technology Integration:

    We integrate AI, wearables, and third-party tools to optimize trial processes and enable smarter data collection.
  • Commitment to Compliance:

    We integrate 21 CFR Part 11, GCP, HIPAA, GDPR, ICH E6, FDA, and EMA guidelines to ensure Compliance and secure data handling throughout the trial process.
  • Faster Time-to-Market:

    Accelerate your clinical trials with tools that streamline processes and reduce operational bottlenecks.
  • Exceptional Post-Deployment Support:

    Receive ongoing support to ensure your system evolves with changing research demands and technology trends.
  • Proven Track Record:

    Benefit from our successful delivery of innovative solutions across diverse therapeutic areas and industries.

Our Impact on Numbers:

  • 10+ Clinical Trial Solutions Delivered: Successfully developed and deployed clinical trial management systems for various research organizations, ensuring efficiency and Compliance.
  • 95% Client Satisfaction Rate: We achieved high satisfaction from pharmaceutical companies, CROs, and research institutions through our tailored CTMS solutions.
  • 7+ Therapeutic Areas Supported: Our solutions cater to diverse therapeutic areas, including oncology, cardiology, neurology, and rare diseases.
  • 16 Years of Excellence in Life Science: Empowering clinical research since 2009 with innovative, scalable, and regulatory-compliant software solutions.
  • 35% Reduction in Trial Timelines: Our CTMS solutions help streamline operations, resulting in faster study setup, execution, and reporting.

Have anything interesting in your mind?Reach out to us.

Some of the Clinical Trial Management Software Development Services We Offer

Centralized Study Management

We streamline your clinical trials with a unified platform that simplifies planning, execution, and monitoring. Our custom tools, including drag-and-drop study design and real-time dashboards, ensure seamless coordination across all trial stages.

Electronic Data Capture (EDC)

As a clinical trial management software development company, We enhance the accuracy of your clinical data with intuitive form creation, dynamic visit structures, and offline data entry. Our secure and user-friendly EDC tools simplify data collection and ensure reliability throughout the trial process.

ePRO (Electronic Patient-Reported Outcomes)

We empower patients to report outcomes easily through customizable surveys and secure platforms. Real-time data syncing and secure auto-lock functionality guarantee precise and reliable patient-reported data.

Real-Time Data Monitoring and Insights

We provide cutting-edge monitoring capabilities, including interactive dashboards and built-in analytics. Our role-based access and tailored reports enable precise tracking of trial endpoints for actionable insights.

Risk-Based Monitoring (RBM)

We prioritize your monitoring efforts by focusing on high-risk areas using AI-driven risk identification tools. Our automated safety reporting and advanced analytics ensure efficient and focused trial oversight.

eConsent and Compliance Tracking

We simplify the consent process with electronic tools integrating compliance checks and audit trail-enabled documentation. Our seamless eSignature capabilities provide transparency and regulatory assurance.

Patient Recruitment and Management

We optimize participant recruitment with automated email campaigns, shared calendars, and detailed metrics tracking. Our centralized management system ensures streamlined collaboration and improved recruitment success.

Document Management System

We centralize document handling through secure storage, eTMF integration, and compliant eSignatures. Our solution ensures efficient tracking and regulatory adherence for all clinical trial documents.

Advanced API and System Integrations

We enhance your trial workflows by seamlessly integrating wearables, EMR systems, and third-party tools. Our advanced API capabilities enable custom functionalities tailored to your needs.

Budget and Financial Tracking

Our clinical trial management software development services help you manage trial finances effectively with automated participant payments, configurable cost tracking, and detailed financial reports. Our tools ensure transparency and streamlined workflows.

Hybrid and Decentralized Trial Support

We support modern trial models with remote data capture, wearable integration, and home visit management. Our features, including patient diary apps and real-time data synchronization, ensure seamless hybrid and decentralized trials operations.

Our Services Spread Across

We have offices in San Francisco, California, Nashville Tennessee, New York in the US, and Bangalore, Mumbai in India. We also service clients from Delhi NCR, Chennai, Pune, Hyderabad, Ahmedabad, Toronto, Montreal, Canada, Dubai UAE, Saudi Arabia, Qatar, Kuwait, France, Italy, Switzerland, London UK, Netherlands, Ireland, Germany, and other parts of Europe.

Clinical trial management software development company

Who We Serve

  • Pharmaceuticals

    Empowering pharma companies with scalable, compliant solutions for managing clinical trials efficiently.
  • Biotechnology

    Supporting biotech firms with innovative tools to accelerate research and development in various therapeutic areas.
  • Contract Research Organizations (CROs)

    Providing CROs with flexible, end-to-end solutions for efficient trial management and reporting.
  • Academic Research Centers

    Enabling academic institutions to conduct streamlined, compliant clinical research with advanced tools.
  • Medical Device Manufacturers

    Facilitating trials for medical device approvals with customized, regulatory-focused software solutions.
  • Healthcare Providers

    Enhancing collaboration and data sharing in clinical research conducted by hospitals and health systems.

Why Fortunesoft Excels in Product Engineering?

At Fortunesoft, we excel in product engineering by delivering high-quality solutions, driving innovation, and ensuring the seamless integration of healthcare technologies.

Product Engineering

Our expertise in healthcare product engineering ensures that your app is developed with a focus on reliability, performance, and compliance with healthcare standards.

Agile Development

We adopt agile methodologies to maintain flexibility and adaptability throughout the development process, allowing for rapid iterations and prompt adjustments based on client feedback.

DevOps Methodology

Integrating development and operations, we ensure smoother deployments, faster time-to-market, and consistent application performance.

Continuous Integration

Our continuous integration practices guarantee that code is regularly tested and integrated, reducing errors and ensuring a seamless development process.

Testimonials

What Clients Say About Us

Fortunesoft IT Innovations has been an outstanding business partner for our company. After a terrible experience using offshore developers, we took a chance on Fortunesoft IT Innovations and they have been excellent to work with. The team is relentless in following agile development processes. They took the time to learn our business and it shows in the quality of the work they do. Their team has a broad range of skillsets and were able to help us with every aspect of our start-up company.

Conner Humphrey
HGR, US

Competence, Service and Support are excellent. Our design tool works great and now generates revenue. The team is with you from building the website to making sure it runs smoothly even after the project is complete. Looking forward to creating more online solutions for our customers with fortunesoft!

Jaysond Miclat
Business Development Director, CollegeWear Inc, California, US

The group was thoughtful, smart, agile, and met all of our requirements.

Sean Colandrea
HGR, US

I really appreciate the team’s efforts. It has been a pleasure to see this project become a reality. My hope is that the website will then stand as a testament to all of the effort invested in it by so many people. Thank you again for all of your support and assistance.

Katinka Csizmadi
Communications Assistant Manager, Live Language – Glasgow, Scotland.

A pleasure to work with. The project was actually delivered ahead of schedule. Regular scrum calls were clear and efficient. On budget and ahead of schedule. We will definitely work with them again.

Robert Brown
CEO, Options Away LLC – Chicago, US.

Frequently Asked Questions

Have questions? We are here to help.

Fortunesoft serves various locations across the US, including but not limited to:

· New York, New Jersey, Connecticut – NYC, Manhattan
· Baltimore, Philadelphia, Columbia – Washington DC, Virginia, Pennsylvania, Maryland, Richmond, Arlington, Pittsburgh, etc.
· Nashville, Tennessee – Memphis, Gallatin, Franklin
· San Francisco, Bay Area, San Jose – California, Oakland, Fremont, Sunnyvale, Mountain View, Palo Alto, Santa Clara, Cupertino, etc.
· Chicago, Aurora – Illinois
· Florida – Miami, Tampa, Jacksonville, Orlando
· Texas – Dallas, Houston, San Antonio, Austin, Fort Worth
· California – Los Angeles, San Diego, Long Beach
· Boston, Massachusetts – Cambridge, New Hampshire
· Georgia – Atlanta, Columbus
· Colorado, Kansas – Denver, Colorado Springs

We also serve other locations across the United States and Canada. Contact us to find out how we can assist you in your city!
CTMS is a software solution used to plan, track, and manage clinical trials. It centralizes data and automates tasks to improve efficiency, Compliance, and data accuracy.
It improves efficiency, ensures Compliance, simplifies documentation, and supports real-time decision-making, reducing trial delays and errors. 
Key features include study planning, site management, patient recruitment tracking, data management, compliance monitoring, real-time reporting, etc.
CTMS automates manual tasks, provides real-time data access, and improves communication, leading to faster and more efficient trials.
Yes, CTMS can integrate with EHR, LIMS, and EDC systems for seamless data exchange and better operational efficiency.
CTMS uses encryption, audit trails, and access control to meet regulatory standards like 21 CFR Part 11 and HIPAA.
Sponsors benefit from improved efficiency, Compliance, cost management, and access to real-time trial insights.
Yes, CTMS is scalable and can be tailored for small trials. It offers efficient data management and compliance tools.
Yes, Fortunesoft offers custom Clinical trial management software development tailored to your specific workflows, data requirements, and integration needs.
Yes, CTMS supports remote trials by offering digital monitoring, e-consent, and real-time data access, which makes them more flexible.
The development timeline depends on customization and complexity, typically ranging from a few months to over a year.
Yes, Fortunesoft provides ongoing maintenance, bug fixes, updates, and support to ensure your CTMS remains functional and compliant.
Focus on user-friendly design, automation, Compliance with regulatory standards, and integrations with existing systems. Regular updates and adaptability are also crucial.
The cost varies based on features, complexity, and customization. Contact Fortunesoft for a tailored estimate based on your requirements.

Our Locations

Nashville, US

Fortunesoft IT Innovations, Inc.,

180 N Belvedere Dr, Suite 7C, Gallatin, Nashville, TN 37066, United States

+1-615-298-7395

Bangalore, India

Fortunesoft IT Innovations Pvt. Ltd.,

#19, KMJ Ascend, 17 C Main, 1st Cross Road, 5th Block Koramangala Bangalore, KA 560095, India

080-42005185

San Francisco, US

Fortunesoft IT Innovations, Inc.,

Downtown Sunnyvale 640 W. California Avenue, Suite 210, Sunnyvale San Francisco, CA 94086, United States

+1-615-298-7395

Singapore

Fortunesoft IT Innovations Pte. Ltd.,

30 Cecil Street, # 19-06, Prudential Tower Singapore 049712

+65-3158-1762

Sydney, Australia

Fortunesoft IT Innovations

Australia Square Plaza, Level 4,5 & 12,

95 Pitt Street, NSW, Sydney, 2000

+61-2831-14561

Nashville, US

Fortunesoft IT Innovations, Inc.,

180 N Belvedere Dr, Suite 7C, Gallatin, Nashville, TN 37066, United States
+1-615-298-7395

San Francisco, US

Fortunesoft IT Innovations, Inc.,

Downtown Sunnyvale 640 W. California Avenue, Suite 210, Sunnyvale San Francisco, CA 94086, United States
+1-615-298-7395

Bangalore, India

Fortunesoft IT Innovations Pvt. Ltd.,

#19, KMJ Ascend, 17 C Main, 1st Cross Road, 5th Block Koramangala Bangalore, KA 560095, India
+91-9900002145

Singapore

Fortunesoft IT Innovations Pte. Ltd.,

30 Cecil Street, # 19-06, Prudential Tower Singapore 049712
+65-3158-1762

Sydney, Australia

Fortunesoft IT Innovations

Australia Square Plaza, Level 4,5 & 12,
95 Pitt Street, NSW, Sydney, 2000
+61-2831-14561

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