Clinical Trial Management Software Development Company
A company specializing in building advanced digital solutions that enable pharmaceutical companies, CROs, and research organizations to plan, track, and manage clinical trials seamlessly across all phases.
We offer end-to-end clinical trial management software development services, including product strategy, UI/UX design, EDC & ePRO integration, compliance assurance, deployment, and continuous support, ensuring faster study execution, accurate data capture, and regulatory-ready operations.
With deep expertise in developing CTMS platforms and digital health solutions since 2009, Fortunesoft stands as a trusted clinical trial management software development company.
We help research teams accelerate trial timelines, optimize participant engagement, and improve data integrity through intelligent, scalable, and audit-ready CTMS solutions tailored for diverse therapeutic areas. At Fortunesoft, we are experts at delivering:
Compliance-Driven, Secure Architecture
Every CTMS solution we build is designed with regulatory compliance and data security at its core. Our architecture supports FDA 21 CFR Part 11, GCP, HIPAA, and GDPR standards, ensuring sensitive clinical trial data remains secure while enabling smooth operational workflows.
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 EDC, ePRO & 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 developing a Clinical trial management system?
1. Expertise in Clinical Trial Technology and Regulations
We understand the intricacies of clinical research and build CTMS platforms that meet global standards like ICH GCP, FDA 21 CFR Part 11, HIPAA, and GDPR.2. Proven Experience in Building Research-Grade Software
Our portfolio includes the successful delivery of clinical trial platforms, helping sponsors and CROs streamline operations, reduce delays, and ensure compliance.3. Agile Development Aligned with Trial Lifecycles
We follow an agile methodology tailored to the clinical trial process, allowing flexibility, fast iterations, and ongoing collaboration with research teams.4. Cross-Functional Teams with Clinical Domain Knowledge
Our developers work alongside experts in clinical operations, compliance, and UX to ensure your software is both powerful and intuitive.5. End-to-End Support From MVP to Scalable Solution
Whether you’re building a prototype or launching a full-featured CTMS, we support you through every phase, from ideation to post-launch enhancements.6. Strong Focus on Security, Privacy, and Auditability
Data protection and audit readiness are built into every layer of your CTMS, ensuring trust, transparency, and adherence to regulatory expectations.7. Customization to Match Your Trial Processes
We don’t believe in one-size-fits-all. Our solutions are tailored to fit your specific study workflows, organization size, and operational requirements.8. Trusted Partner for CROs, Sponsors, and Institutions
We’ve worked with a wide range of clients across the clinical research space, delivering dependable, scalable, and user-centric CTMS solutions.
We Know What You Want
At Fortunesoft, we understand the exacting standards and regulatory requirements that Pharma and CRO clients demand. That’s why our clinical trial software solutions come with thorough documentation and compliance built in, so you can be confident in quality, security, and audit readiness.
Our Deliverables Include:- Validation Summary
We provide comprehensive validation reports aligned with industry-leading standards such as FDA 21 CFR Part 11 and GAMP 5, ensuring your software meets regulatory expectations and performs reliably.
- Quality Management System (QMS) Overview
Our QMS adheres to industry standards and integrates pharmaceutical best practices like ICH Q10 and GxP guidelines to maintain consistent quality throughout development and deployment.
- Standard Operating Procedures (SOPs)
We maintain and share sample SOPs based on rigorous GxP compliance and data integrity principles (including ALCOA+), providing transparent insight into our controlled and repeatable processes.
- Audit Readiness Statement
We ensure you’re fully prepared for regulatory audits from bodies like the FDA, PMDA, and others, with documented procedures and systems aligned to standards.
- Information Security Controls Summary
Protecting your sensitive clinical data is paramount. Our security controls follow ISO/IEC 27001 standards, with encryption, access management, and compliance with regulations like HIPAA and GDPR, tailored to your needs.
Have anything interesting in your mind?Reach out to us.
Core Capabilities in Our Clinical Trial Management Software Development Services
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 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.
Our CTMS Solutions for Diverse Research Fields
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
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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