Decentralized Clinical Trial Solutions in Kenya
DCT Platforms Designed for Regulatory Requirements
Decentralized clinical trial platforms designed to support secure study operations, data management, and applicable regulatory requirements for sponsors and CROs across East Africa.
17 +
Years of Service
150 +
Happy Clients
510 +
Successful Projects
2400 +
Successful Sprints
Introduction
Why Do Decentralized Trials Stall?
Decentralized studies can become difficult to manage when participant activities, research teams, study data, and operational tasks are spread across different locations. Without a unified approach, teams may face gaps in communication, inconsistent data handling, and limited visibility into study progress.
Fortunesoft develops technology for decentralized clinical research that helps organize study activities within a structured digital ecosystem. The platform can support participant interactions, remote data collection, study coordination, and essential compliance processes while giving research teams greater visibility into ongoing activities.As study requirements change, the technology can be adapted to support different research models, participant volumes, and geographic needs. This gives clinical research teams a practical foundation for managing distributed studies without adding unnecessary complexity to their day to day operations.
Cloud-Native DCT Architecture
Modular, cloud-native trial architecture built for high availability and elastic scaling.
Security-First DCT Design
Role-based access, encryption, and audit trails protect patient data from day one.
Real-Time Trial Visibility
Live dashboards and reporting give teams clear visibility into trial progress and site performance.
Decentralized Clinical Trial Software Development Services
End-to-end clinical trial software development built around the security, compliance, and scalability needs of life sciences organisations.
DCT Architecture & System Design
Secure, modular decentralized trial architectures designed with regulatory alignment from the first decision.
Legacy Trial System Modernization
Phased, risk-managed migration to cloud-enabled DCT environments that keeps active trials running.
21 CFR Part 11 Security Controls
Encryption, role-based access, identity management, and audit trail capabilities designed around applicable 21 CFR Part 11 requirements.
DCT Infrastructure Management
Monitoring, performance tuning, and cost controls keep trial operations reliable across study phases.
Disaster Recovery & Continuity
Backup, recovery, and failover strategies help maintain the availability and resilience of mission-critical research environments while supporting applicable requirements.
DevOps & Trial Automation
CI/CD and governed releases speed up platform upgrades while protecting data consistency and compliance.
Speak with our team about your decentralized trial platform.
Let Intelligence Work With You, Not Just For You
Agentic AI Engineering
Autonomous, multi-agent systems built to make decisions, collaborate, and execute complex tasks.
Vertical AI Consulting
Combining agentic intelligence with deep domain knowledge in EHRs, clinical ops, regulatory tech, and financial systems for maximum contextual precision.
LLM Toolchains & Production Systems
Integrating curated LLMs, secure RAG pipelines, and reusable components to accelerate delivery - without compromising on compliance or performance.
Our Agentic AI doesn’t just process—it perceives, learns, and acts. Build intelligence that understands your domain - and drives real action.
Compliance
Regulatory Requirements for Clinical Research in Kenya
Kenya Data Protection Act
Privacy-focused design practices help protect participant and research data while addressing applicable requirements under Kenya's Data Protection Act.
PPB Regulatory Alignment
Workflows can be designed around applicable Pharmacy and Poisons Board requirements for clinical trials and investigational products.
Good Clinical Practice (GCP)
Supports GCP principles across trial documentation, data integrity, and study oversight.
FDA 21 CFR Part 11
E-records, e-signatures, and audit trail capabilities designed around applicable FDA requirements for global clinical studies.
GDPR-Aligned Data Protection
Privacy-focused design for multi-country studies and cross-border data sharing, with workflows aligned to applicable data protection requirements.
Why Fortunesoft for Decentralized Clinical Trial Solutions?
Fortunesoft brings 17+ years of software engineering experience to clinical research and digital health platforms, with regulatory considerations incorporated into solution design.
17+ Years in Life Sciences Technology
Over 17 years building software for clinical research and digital health, across oncology, rare disease, and multi-country programs, means we understand the data sensitivity and operational complexity trials demand.
Compliance-Focused DCT Development
21 CFR Part 11, ICH GCP, and applicable global requirements inform system architecture, access governance, and validation from the beginning of development.
Modern DCT Technology Stack
Cloud-enabled architecture with automation, observability, AI readiness, and API connectivity for high-performance research workloads.
Clinical Research-First Design
Platforms are designed around protocol variability, data sensitivity, and site readiness differences, so they work in real research environments, not just demos.
Rapid DCT Innovation Cycles
Agile and DevOps delivery brings faster modernisation and continuous enhancements without disrupting active trials.
Proven Delivery Across Africa
Fortunesoft supports research organisations, sponsors, and CROs seeking digital clinical trial solutions across African markets, including Kenya and other regional markets.
Partner with a team that stays with you well beyond go-live.
DCT Software Capabilities Across the Trial Lifecycle
Study Design & Protocol
Site Selection & Activation
Recruitment & Engagement
Clinical Data Management
Regulatory & Ethics Filings
DCT & Hybrid Trial Enablement
Safety & Pharmacovigilance
Biostatistics & Analytics
Post-Trial Reporting Support
Key Integrations for DCT Software
EDC Integration
Tested two-way data exchange with EDC systems helps reduce manual reconciliation and maintain accurate trial data.
EHR Integration
HL7 and FHIR interoperability with hospital EHRs supports eligibility checks and source data verification.
Wearables & Remote Monitoring
Connects wearables and monitoring platforms for continuous patient data aligned to trial endpoints.
Pharmacovigilance & Safety Systems
Automated safety data exchange supports adverse event reporting and signal detection workflows.
Trial Challenges
We Solve
Fragmented DCT Tools
Recruitment & Retention
Regulatory Inconsistency
Remote Data Integrity
eConsent Complexity
System Interoperability
Data Privacy Risks
Supply Chain Management
Site Readiness Gaps
Real-Time Safety Signals
From protocol design to post-trial reporting, we cover every phase of your clinical research lifecycle.
Clinical Trial Software
Development Process
Discovery & Alignment
We align sponsors, CROs, sites, and IT teams on protocol, regulatory, and integration requirements first.
Architecture & Compliance
Scalable, secure architecture designed around applicable GxP, HIPAA, and 21 CFR Part 11 requirements from the outset.
Clinical Workflow UX
Interfaces for investigators, sponsors, and patients shaped around real clinical time and device constraints.
Development & Integration
Integration modules connect EDC, CTMS, EHR, lab, and wearable platforms through standards-based APIs, with testing based on project requirements.
Validation & Security Testing
CSV activities, IQ/OQ/PQ documentation where applicable, penetration testing, and load testing help validate system performance, security, and readiness for regulated environments.
Deployment & Ongoing Support
GxP-aligned deployment with monitoring, backup, and continuous enhancement as trial needs evolve.
Security Hardening and Performance Testing
Implementing encryption, access controls, penetration testing, and load testing to verify system performance and security posture under realistic production conditions and peak trial activity scenarios.
Deployment and Environment Configuration
Configuring production-ready cloud environments with monitoring, automated backup, failover mechanisms, and environment documentation aligned with GxP infrastructure qualification requirements.
Ongoing Support and Continuous Enhancement
Post-deployment maintenance, regulatory update management, performance optimization, and feature enhancements, ensuring the platform remains current as trial requirements, regulatory guidance, and research priorities evolve.
A structured, compliance-embedded development process built to keep your trial on time, on budget, and audit-ready.
Outcomes That Speak Louder Than Promises
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Testimonials
Hear from Those Who
Chose 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
Co-Founder, SalesC2, 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.
Dr. Telma Ingles
CEO, Kwattel SA
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
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.
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.
Rajagopalan M
Head of Regional Solutions- Ecosystem Partnerships & Marketplaces DBS Bank, Singapore
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.
The group was thoughtful, smart, agile, and met all of our requirements.
Sean Colandrea
Co-Founder, ClinicalC2, US
Case Studies from Inc. 5000, FORTUNE 500, NASDAQ listed companies to stealth startups
Awards & Recognition
Celebrated for Innovation. Trusted for Excellence
Over the years, Fortunesoft has been recognized for its commitment to innovation, quality, and customer success in the FinTech and Healthcare technology space.
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