Clinical Trial Management Software Development Company
Managing clinical trials demands more than standalone systems, it requires integrated, compliant, and scalable software that supports decentralized, hybrid, and traditional trial models.
Fortunesoft is a clinical trial software development company delivering EDC, ePRO, and CTMS solutions built for data integrity, security, and regulatory compliance. By leveraging AI and automation, we enable efficient trial management through patient engagement, randomization, supply chain, and reporting modules.
With over 16 years of experience in Life Sciences software development, Fortunesoft delivers end-to-end decentralized clinical trial solutions that evolve with study complexity and scale. From cloud-native architectures and system integrations to performance optimization and long-term support, we help organizations modernize clinical trial management and successfully execute decentralized and global studies.
At Fortunesoft, we provide clinical trial management software development services with expertise in:
AI-Powered Trial Optimization & Predictive Insights
We leverage AI and advanced analytics to transform trial data into actionable intelligence. From predictive recruitment analytics to real-time protocol deviation alerts, our systems empower research teams with the tools to make faster, evidence-based decisions.
Seamless Integration with ePRO, EDC & Wearable Devices
Our CTMS solutions offer interoperability with leading EDC platforms, ePRO(electronic Patient-Reported Outcomes) systems, LIMS, and IoMT-enabled devices, ensuring unified data flow and real-time monitoring across trial sites for greater transparency and efficiency.
Why Choose Fortunesoft for Decentralized Clinical Trial Solutions?
Focused Solely on Healthcare & Clinical Research
Fortunesoft is different from other software development companies because we focus exclusively on healthcare and clinical research. Being a specialized clinical trial software development company enables us to deliver compliant, research-grade solutions that general software development companies cannot match.End-to-End Clinical Trial Technology Solutions
We design and develop custom clinical trial software including CTMS, EDC, ePRO, eConsent, and trial analytics platforms. Each solution is tailored to sponsors, CROs, and research organizations to support efficient study planning, execution, and monitoring.Built for Regulatory Compliance and Audit Readiness
We design clinical trial systems with compliance built from the start. Our development process aligns with FDA 21 CFR Part 11, GAMP 5, ICH-GCP, HIPAA, and GDPR, supported by structured documentation and validation practices expected by Pharma and CROs.Strong Quality Management and Controlled Development Processes
Our development approach follows a robust Quality Management System that incorporates GxP principles, ICH Q10 guidance, and ALCOA+ data integrity standards. This ensures consistent quality, traceability, and controlled delivery across the software lifecycle.Enterprise-Grade Security and Data Protection
We implement ISO/IEC 27001 aligned security controls, including encryption, access management, and secure system architecture, to protect sensitive clinical trial data while meeting established privacy requirements.
Clinical Trial Management & Operations Solutions We Offer
- Merge Clinical Trial Management System
- Clinical Trial Safety Management System
- Clinical Trial Data Management System
- Clinical Trial Supply Management System
Merge Clinical Trial Management System- Clinical Trial Document Management System
- Clinical Trial Learning Management System
- Clinical Trial Quality Management System
- Clinical Trial Management System Training
Have anything interesting in your mind?Reach out to us.
Our Clinical Trial Software Development Services
Clinical Trial Technology Consulting
Our consulting services help sponsors, CROs, and research organizations define the right clinical trial technology strategy. We assess study workflows, regulatory requirements, and data needs to create a clear roadmap for compliant, scalable, and future-ready clinical trial systems.
Custom Clinical Trial Software Development
As a clinical trial software development company, we build fully customized platforms tailored to your study designs and operational models. From CTMS and EDC to ePRO and eConsent systems, our solutions are secure, scalable, and designed to support efficient trial execution.
Regulatory Compliance and Validation Services
We develop clinical trial software with compliance and validation built in. Our services include documentation, validation support, and system design aligned with FDA 21 CFR Part 11, GAMP 5, ICH-GCP, HIPAA, and GDPR, ensuring audit readiness throughout the trial lifecycle.
UI and UX Design for Clinical Trial Systems
We design intuitive and role-based user interfaces for investigators, monitors, sponsors, and patients. Our UX approach improves usability, reduces training effort, and supports faster adoption across clinical research teams.
Clinical Trial Web Application Development
We build secure, high-performance web-based clinical trial platforms that support study management, data capture, monitoring, and reporting. Our web solutions are designed for interoperability, scalability, and consistent performance across global trial operations.
Clinical Trial Mobile Application Development
Our team develops mobile applications for clinical trials that support patient engagement, data collection, and remote participation. These applications enable ePRO, notifications, and task management while maintaining data integrity and compliance.
Clinical Trial System Modernization Services
We modernize legacy clinical trial systems by upgrading architecture, improving performance, and enhancing usability. Our modernization services help organizations extend system lifecycles while improving scalability, security, and compliance.
Clinical Trial Integration Services
We integrate clinical trial platforms with EHR/EMR systems, laboratory systems, data warehouses, and third-party research tools. These integrations enable seamless data flow, reduce manual effort, and improve trial visibility.
Cloud-Based Clinical Trial Platform Development
Fortunesoft develops cloud-native clinical trial platforms designed for scalability and reliability. Our cloud architectures support multi-study operations, global users, and high availability while maintaining strong security controls.
Advanced Technology and Automation Solutions
We incorporate automation and advanced analytics into clinical trial software to streamline workflows and reduce operational burden. This includes automated data workflows, reporting, and intelligent insights to support faster, data-driven decision-making.
Maintenance and Ongoing Support
Our maintenance and support services ensure clinical trial systems remain stable, secure, and compliant. We provide continuous monitoring, updates, performance optimization, and support throughout the lifecycle of your clinical trial software.
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.
Decentralized Clinical Trial Technology Solutions We Offer
- Clinical Trial Management Solutions
- Decentralized Clinical Trial Solutions
- Clinical Trial Analytics Solutions
- Clinical Trial Workflow Solutions
- Pharma Clinical Trial Solutions
- Clinical Trial Payment Solutions
- Clinical Trial Automation Solutions
- Clinical Trial Business Development Solutions
- Clinical Trial Recruitment Solutions
- Clinical Trial Optimization Solutions
- Clinical Trial Drug Sourcing Solutions
- Clinical Trial Protocol Solutions
- Clinical Trial Biometric Solutions
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
Working with Fortunesoft on the development of our Iguana Fintech Solutions, Credit Lending Platform and Middleware Solution has been a truly positive experience. Fortunesoft team has shown a deep understanding of middleware architecture, excellent problem-solving skills, and strong expertise in API integration. Their collaborative approach and efficiency have contributed greatly to a smooth and productive development process.
CEO, Kwattel SA
When I have an idea that needs to be translated into a capability, I reach out to you Fortunesoft Team. Thanks for never letting us down. I’ll be glad to refer Fortunesoft team and speak of their skill set and commitment to the projects & timelines. I’ve engaged Fortunesoft team on multiple occasions over a period of 2+ years to build Commerce and payment capabilities on SaaS and OnPrem infrastructures.
Head of Regional Solutions- Ecosystem Partnerships & Marketplaces DBS Bank, Singapore
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.
Co-Founder, SalesC2, 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!
Business Development Director, CollegeWear Inc, California, US
The group was thoughtful, smart, agile, and met all of our requirements.
Co-Founder, ClinicalC2, 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.
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.
CEO, Options Away LLC – Chicago, US.
Frequently Asked Questions
Have questions? We are here to help.
· 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!
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
Nairobi, Kenya
Fortunesoft Africa Limited
Fortis Suites, Hospital Road, Upper Hill, Nairobi, Kenya
P.O BOX 18809, 00500-Enterprise Road
+254 117 325 335
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
Nairobi, Kenya
Fortunesoft Africa Limited
Fortis Suites, Hospital Road, Upper Hill, Nairobi, Kenya
P.O BOX 18809, 00500-Enterprise Road
+254 117 325 335
Sydney, Australia
Fortunesoft IT Innovations
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