Clinical Trial Management System Development Company
As a trusted clinical trial management software development company, we have experience in building safe and accurate technology solutions for life sciences. With our in-depth domain knowledge and engineering, we develop scalable and fast clinical trial management systems that optimize end-to-end trial operations.
Our agile approach combined with continuous testing enables us to deliver high-quality software on time. By partnering with us, healthcare institutes and CROs can accelerate trials while maintaining compliance and generating actionable insights. Get in touch with us to transform your clinical trials leveraging the power of technology.
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Why Choose Us as Your Clinical Trial Management System Development Company?
Proven Healthcare IT Expertise: With over 15 years of experience and 500+ software projects, we have honed our development skills specifically for the healthcare sector.
End-to-End Capabilities: We provide full-spectrum services from planning, UX/UI design, engineering, and testing to deployment and maintenance for clinical trial systems.
Compliance Focus: Our clinical trial solutions are engineered keeping stringent compliances like 21 CFR Part 11, HIPAA, and GDPR in mind right from the design stage.
Skilled Healthcare Developers: Our talented teams comprise clinically trained professionals who blend domain experience with software expertise for building intuitive and the best clinical trial management systems.
Rapid Delivery: Using agile development methodology, continuous integration, and testing automation, we deliver high-quality software quickly without compromising on quality.
Flexible Engagement: We provide flexible engagement models like dedicated development teams, project-based pricing, and offshore development centers to meet diverse customer needs.
By partnering with us for clinical trial management software, Healthcare institutes, and CROs can achieve significant benefits:
- Faster trial execution with streamlined workflows
- Enhanced compliance with built-in audit trails, e-signatures, and role-based access
- Improved productivity through workflow automation
- Real-time analytics and reports for data-driven decisions
- Cost optimization through accelerated timelines
- Seamless collaboration between study teams and sites
Our extensive experience in clinical trial technology enables us to develop innovative solutions that transform the way trials are conducted.
Clinical Trial Management Software Modules
A cloud-based clinical trial software comprises multiple interconnected modules:
Study Design and Planning:This module enables to design of studies and creates protocol specifications, timelines, enrollment criteria, and site selection parameters. The system allows version control for protocols and supports study amendments. Users can model patient journeys and project site workloads.
Investigator Management:Healthcare institutes can view profiles of research sites and investigators globally, assess performance history, and select sites that match study requirements. The system facilitates easy collaboration for exchanging documents like FDA 1572, budgets, and contracts.
Regulatory Document Management:In this module, we provide a centralized repository for all study-related documents like protocols, ICFs, CRFs, ethics submissions, and approval letters with version histories. Users can submit documents to regulatory bodies from within the system.
Subject Enrollment and Management:Sites and healthcare institutes can configure eligibility criteria and e-screening parameters. The system enables patient e-recruitment via integrated portals and manages the informed consent process electronically. It tracks enrollment milestones in real time.
EDC (Electronic Data Capture):This module allows intuitive data entry at sites through eCRFs integrated with medical devices for accurate data collection. It supports complex edit checks and queries in EDC clinical trial software. Also, provides built-in calculators that automate complex derivations.
Clinical Trial Supply Management Software:The system enables planning, forecasting, packaging, and distribution workflows for investigational materials like drugs and devices. It tracks inventory at depots and site level with chain of custody and supports re-supply based on projected demand.
Safety Management:Users can expedite adverse event reporting by sites with accurate attribution and narrative recording. The system categorizes events and assesses causality, severity, and expectedness. It generates aggregate safety reports for regulators.
Analytics and Reporting:Healthcare institutes can generate real-time reports on enrollment status, data quality, protocol deviations, site metrics, safety trends, and projected study completion. Data extracts can be generated for statistical analysis.
Invoicing and Payments:This module automates clinical trial billing, invoicing, and payment workflows. Sites can submit per-patient and procedure-based costs electronically. Our clinical trial billing software facilitates invoice approvals and integrated payments.
Integrations:The system can integrate via APIs with clinical platforms like CTMS, IWRS, safety databases, central lab systems, and EHRs for end-to-end orchestration.
These interconnected modules optimized on a unified platform provide Healthcare institutes with complete visibility and control over end-to-end trial execution, enabling accelerated development cycles without compromising quality or compliance.
Benefits of Clinical Trial Management Software
Let's learn about the benefits of clinical trial software for different roles including CROs, sites, and patients.
For CROs
- Accelerated Trial Timelines: By automating cumbersome manual processes, the software significantly reduces delays in trial execution. This enables faster completion of trials and quicker time-to-market for new therapies.
- Remote Monitoring: Dashboards provide real-time visibility into global trial operations, reducing onsite visits. This optimizes travel costs and human resources.
- Improved Compliance: Detailed audit trails, e-signatures, and version control enhance transparency. This enables proactive risk mitigation and fewer regulatory observations.
- Operational Efficiency: Streamlined workflows and real-time metrics reduce manual efforts and paperwork. This results in improved productivity and faster task completion.
- Data Integrity: In-built validations and integration with devices improve data accuracy at source, reducing queries. This leads to analysis-ready datasets faster.
- Real-time Insights: We provide customizable dashboards that enable data-driven decisions on recruitment, safety, and resource allocation for faster issue resolution.
- Cost Optimization: By reducing delays, efforts, and complexity, the software significantly cuts overall trial costs through accelerated timelines.
For Hospital Sites
- Intuitive Workflows: The software provides guided step-by-step workflows that simplify traditionally complex and fragmented manual processes for safety reporting, drug inventory management, and other critical site-level trial activities. This reduces the learning curve and overall training needs for site staff.
- Reduced Data Entry: Seamless integration with medical devices and diagnostic equipment allows clinical data to be electronically captured at the point of generation. This eliminates the need for duplicate manual data entry into the system by site staff, enabling faster completion of intricate case report forms.
- Training Management: The system enables proactive tracking and management of training requirements for site staff. Automatic reminders on pending assignments ensure all users complete necessary GCP, protocol-specific, and system training modules. This ensures staff training compliance.
- Query Management: The software provides structured workflows for query generation, submission, tracking, and resolution between global sites and the sponsor team. This enables significantly accelerated turnaround times for query processing leading to cleaner, analysis-ready datasets.
- Resource Optimization: The system provides integrated modules for coordinating patient visit schedules, investigational drug inventory and supply forecasts, and logistics management. This enables optimum planning and resource allocation, preventing bottlenecks like stock-outs or the expiry of unused investigational materials.
- Secure Access Control: Granular, role-based access permissions integrated with multi-factor authentication enforce authorized user access to specific datasets and modules in the system. This minimizes security risks associated with inadvertent access compared to predominantly manual access control methods.
- Faster Payments: Workflow automation around site budget set-up, activity tracking, invoicing generation, submission, and integrated payment processing enables a shorter, predictable site payment cycle. This results in improved cash flows for sites participating in the trial.
For Patients
- Convenient Participation: The ability to electronically review study information, consent to participate, and complete eligibility questionnaires online makes trial participation much more convenient and accessible for patients compared to only in-person, paper-based methods. This can markedly improve enrollment rates.
- Enhanced Safety: The centralized collection of adverse event reports coupled with structured workflows for causality analysis ensures faster and more consistent assessment of safety signals. This strengthens overall vigilance and patient safety management during clinical trials.
- Access to Data: Secure online patient portals provide study volunteers continued access to view their health data like lab results that are collected during the trial. This improves patient engagement beyond just the study period and provides continuity of health data access.
- Compliant Platform: The validated software platform maintains the highest standards of patient data privacy, confidentiality, and informed consent protocols systematically. This assures patients that their rights and health data security are protected.
By optimizing clinical trial processes for all stakeholders, our software solutions deliver tremendous value through accelerated timelines, enhanced quality, improved compliance, and cost efficiency.
Our Clinical Trial Management Software Development Process
We follow a comprehensive process spanning planning, design, engineering, testing, integration, data migration, and post-production support to deliver high-quality and best clinical trial management software:
Requirement Analysis:We start every project by extensively analyzing the client's specific functional needs, users, pain points in current processes, and desired outcomes. Our team includes domain experts who understand the nuances of clinical trial data software needs.
System Blueprinting:
Next, our architects design the overall system architecture, schema, interfaces, integrations, and data flows based on the requirements analysis. Detailed specifications are drawn up.
Prototype Creation:
Working prototypes with key workflows are created for stakeholders to visually interact with and provide quick feedback before the actual build. This validation ensures alignment.
UI/UX Design:
Our design team focuses on maximizing usability and visual appeal for target user groups like investigators, clinical operators, and patients. Compliance mandates are incorporated.
Customized Development:
Our agile software engineering teams then rapidly build the fully functional platform leveraging optimal tech stack aligned to specifications. Developers would code your entire healthcare as per designs and make it a reality for you.
Testing and QA:
The software undergoes rigorous testing like functional testing, integration testing, performance testing, user acceptance testing, and compliance audits iteratively. Then, the bugs are fixed continuously.
Deployment and Integration:
The thoroughly tested software is then deployed on highly secure cloud infrastructure. It is integrated with ancillary systems like CTMS, IWRS, and Labs via APIs for end-to-end orchestration.
Ongoing Support:
Dedicated technical teams continue providing support for enhancements, issue resolution, upgrades, and periodic validation to deliver maximum ROI for the long term.
Our structured methodology with continuous client collaboration enables our clinical software development teams to deliver systems tailored to your unique needs.
Technology Stack for Clinical Trial Data Management Software
Here are some of the leading technologies we use to engineer innovative real-time clinical trial management systems:
| Category | Technologies |
| Frontend Tech | ReactJS, AngularJS, Vue.js, HTML5, SCSS, JavaScript |
| Mobile Tech | Swift, Java, Kotlin, React Native, Flutter |
| Backend Tech | .Net, Python, Node.js, C#, Ruby on Rails, PHP, Java |
| Database | SQL, MongoDB, PostgreSQL, MySQL |
| Cloud Platform | AWS, Google Cloud, Azure |
| Containerization | Docker, Kubernetes |
| Data Analytics | Tableau, Looker, Power BI |
| Testing Frameworks | Jest, JUnit, PyUnit, Selenium, Appium |
| Version Control | Git, GitHub |
| IDEs/Editors | Visual Studio Code, Eclipse, Android Studio |
We leverage leading-edge technology and Agile frameworks that help us to create high-performance, scalable, and intuitive clinical trial software systems.
Regulations Followed in Our Clinical Trial Software
Our software development methodology intricately incorporates compliance with the following critical regulations governing clinical trials right from the design stage:
21 CFR Part 11:Title 21 CFR Part 11 of the Code of Federal Regulations deals with compliance for electronic records and signatures in FDA-regulated environments like clinical trials. We ensure our solutions are created to meet requirements like audit trails, version control, access controls, and digital signature workflows.
HIPAA:The Health Insurance Portability and Accountability Act (HIPAA) establishes standards for the privacy and security of protected health information (PHI). Our solutions are HIPAA-compliant enabling safe PHI access across the extended clinical trial ecosystem.
GDPR:
The General Data Protection Regulation (GDPR) regulates data protection and privacy for EU residents. We make systems that enable GDPR compliance through anonymization, encryption, data ownership controls, and mechanisms for patient consent management.
ISO 14155:
This ISO standard specifies requirements for safety, performance, risk management, ethics, and regulatory compliance for medical device clinical investigations. Our software adheres to ISO 14155 directives for clinical evaluative studies.
ICHF Good Clinical Practice:
This standard provides guidance on the ethics, safety, efficiency, and scientific validity of clinical trials on human participants. You get systems that enable the execution of trials consistently adhering to the ICH GCP code of conduct.
By incorporating regulatory mandates, our enables healthcare institutes to conduct compliant, valid, and ethical studies.
Our Domain Expertise for Healthcare Software:
As one of the leading clinical trial management system vendors, we have experience developing 500+ healthcare IT projects. Besides that, we have deep knowledge and experience building a range of tech solutions for sub-sectors in healthcare:
Telehealth Applications:
Our telemedicine apps and web platforms enable virtual consultations through video, audio, and chat interfaces. Patients can connect with providers remotely and share health records securely. Providers can screen patients, conduct live consults, prescribe medications, and share visit summaries seamlessly.
Health Applications:
We build multi-platform mHealth apps that enable consumers to track vitals, set medication and appointment reminders, access lab results, manage diseases, and share data with providers. The apps incorporate analytics for providers.
Patient Portals:
We develop patient portals integrated with EHRs that allow consumers to view their health records like diagnoses, medications, immunizations, visit summaries, and lab reports securely online. Patients can also book appointments and complete pre-registration formalities.
Healthcare Interoperability:
We implement robust interfacing of disparate healthcare systems like EHRs, Pharmacies, Labs, and Billing Systems enabling seamless data exchange. This allows a holistic view of patient health across the continuum of care.
Custom EHR / EMR Software:
We engineer customized, scalable EHR/EMR systems for hospitals and large provider networks with role-based workflows, customized form builders, and analytics dashboards that enhance care quality and operational efficiency.
Hospital Information Systems:
We develop enterprise-grade systems covering workflows across hospital departments - admissions, outpatient management, clinical decision support, operating room management, materials management, maintenance, accounting, billing, and more.
Payer Solutions:
For payers, we build solutions to manage functions like provider data management, claim processing, payment integrations, care management, utilization reporting, risk adjustment, and compliance processes.
Connected Health IoT:
We enable remote patient monitoring by integrating medical devices like glucometers, pulse oximeters, and wearables via IoT and Bluetooth to capture real-time vitals. Clinical alerts and analytics are incorporated.
Pharmacy Management:
Our pharmacy solutions cover the management of formulary, inventory, drug procurement, stock replenishment, and dispensing workflows while ensuring compliance with controlling agencies.
Laboratory Information Systems
We develop LIS to automate specimen tracking, test management, equipment interfacing, and result reporting with two-way EHR integration for seamless order placement and result reporting.
Dental Practice Management:
Our dental practice solutions include appointment scheduling, billing and reporting workflows, and integrations with imaging systems, labs, equipment, and insurance platforms to manage operations end-to-end.
With our specialized healthcare technology expertise, we enable health systems, physician groups, hospitals, payers, and life science companies to deliver better care and outcomes through technology transformation.
Let's Build Your Healthcare Solution Together
Share your idea with us. Our talented healthcare experts will convert your idea into a functional healthcare solution.
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Clinical Trial Management System Software FAQs
What are the key features of a good clinical trial management system software?
The most useful features of clinical trial software systems include e-consent and e-signatures, centralized document management, electronic data capture (EDC), drug supply forecasts and distribution, safety and adverse event reporting, analytics dashboards, and integration support.
What are some challenges faced in building Clinical Trial Management Software?
Some key challenges involve incorporating complex edit checks and derivation logic in EDC, ensuring multi-format data integration capabilities, enabling multi-site collaboration workflows, building advanced safety monitoring workflows, and meeting stringent compliance regulations.
How can you make Clinical Trial Management Software user-friendly?
The key is to have an intuitive and consistent user interface with self-guided workflows and visual elements that enhance usability for varied user groups like data managers, clinical research associates, investigators, and patients.
What technologies and frameworks are used for clinical trial management tools you develop?
Some popular technology choices include ReactJS, Angular, and Vue for front-end development, Node.js and Python for back-end, MongoDB or PostgreSQL databases, containerization with Docker and Kubernetes for deployment, and cloud platforms like AWS or Google Cloud.
How does clinical trial management software ensure security compliance?
Security is built into the software through controls like role-based access, granular user permissions, two-factor authentication, end-to-end data encryption, detailed audit trails for all transactions, and validations during data entry and edits.
What support does a customer receive post-clinical trial software systems implementation?
Typical post-implementation support includes continuous product upgrades, fixing software bugs, the addition of new features, compliance upgrades, interface building, data migration services, and revalidation testing. Dedicated tech teams provide support.
What is involved in migrating legacy data to a new electronic clinical trial management system?
The process involves extracting data from previous systems, defining a mapping between old and new database schema, writing customized scripts to transform and load data into the new system, validation, and QA testing to ensure accurate migration.
How much does it cost to develop good clinical trial management software?
The cost of clinical trial management software depends on the complexity of required features, integrations, analytics needs, security controls, extent of migration services, hardware specifications, hosting requirements, availability of product requirements, desired timelines, and developer hourly rates.
How long does it take to develop clinical trial management Software?
The typical timeline can range from 3 to 9 months for developing the software with comprehensive features, extensive integration capabilities, and rigorous testing. However, it varies based on scope. An experienced team is needed to meet expedited timelines.
What are the compliance and validation requirements for clinical trial management systems?
Stringent validation is required under regulations like 21 CFR Part 11, Annex 11, HIPAA, GCP, and ISO standards. Traceability matrix, resource management, risk analysis, requirement traceability matrices, risk-based testing, SOPs for system use & changes, and PQ and OQ validation must be implemented.
