DADOS AS
Clinical research has hit a breaking point with traditional data collection methods. Paper forms create delays, errors multiply during transcription, and regulatory compliance becomes a nightmare when dealing with thousands of patient records across multiple sites. That’s exactly why the University Health Network developed DADOS AS (Data Driven Outcome System) to solve these critical challenges.
What makes DADOS AS different isn’t just another electronic data capture platform promise. This system has powered over 700 clinical studies globally, reduced data collection time by 85%, and maintained a 99.7% uptime rate across major healthcare institutions. Real researchers are seeing measurable improvements in study timeline acceleration and data quality enhancement within weeks of implementation.
You’ll discover exactly how DADOS AS transforms clinical research workflows, the specific features that set it apart from expensive commercial alternatives, and step-by-step guidance for implementing this platform in your organization. We’ll also reveal insider strategies that research teams use to maximize ROI and overcome common implementation challenges that could derail your project timeline.
Table of Contents
- What is DADOS AS and Why It Matters
- Core Features and Capabilities
- DADOS AS vs Commercial EDC Platforms
- Implementation Guide and Best Practices
- Pricing and Cost Analysis
- Security and Compliance Framework
- Real-World Case Studies and Results
- Integration with Existing Systems
- Support and Training Resources
- Future Roadmap and Updates
- Frequently Asked Questions
What is DADOS AS and Why It Matters {#what-is-dados-as}
DADOS AS stands for Data Driven Outcome System, an open-source electronic data capture platform specifically designed for clinical research and patient-reported outcomes. Originally developed at the University Health Network in Canada, this web-based platform bridges the gap between research data collection and clinical care delivery.
Here’s what makes DADOS AS particularly compelling for research organizations: it’s built by clinicians for clinicians. The development team understood the real-world challenges that research coordinators face daily. You’re not getting a generic software solution adapted for healthcare – you’re getting a purpose-built clinical research platform.
The Clinical Research Problem DADOS AS Solves
Traditional paper-based data collection creates multiple failure points in clinical research. Research teams spend 40-60% of their time on data entry and verification rather than actual research activities. Patient dropout rates increase when forms are complicated or time-consuming. Data queries from monitors create additional delays that extend study timelines.
DADOS AS addresses these challenges through intelligent design choices. The platform uses computer adaptive testing (CAT) with PROMIS tools that reduce patient burden from 30-minute assessments to 2-3 minute completions. Real-time data validation catches errors immediately rather than during expensive monitoring visits. Mobile-responsive design allows patients to complete forms at home, improving compliance and retention.
Key Market Position
The electronic data capture market is dominated by expensive enterprise solutions like Medidata Rave, Oracle Clinical, and IBM Clinical Development. These platforms can cost $50,000-$500,000+ annually and require extensive technical support teams. DADOS AS provides comparable functionality at a fraction of the cost, making sophisticated EDC capabilities accessible to academic institutions, small biotech companies, and investigator-initiated studies.
What research organizations discover is that DADOS AS often outperforms expensive commercial platforms in usability and patient experience. The platform has been optimized based on feedback from actual research sites rather than corporate development teams who may not understand daily clinical research workflows.
Technology Foundation
DADOS AS runs on a secure, web-based architecture that requires no local software installation. The platform uses modern web standards and responsive design principles, ensuring compatibility across devices and operating systems. Data is stored using advanced encryption standards (AES) with role-based access controls that meet HIPAA and PIPEDA compliance requirements.
The open-source nature means your organization isn’t locked into a single vendor relationship. You can customize the platform for specific research needs, integrate with existing systems, and maintain control over your data architecture. This flexibility becomes particularly valuable for organizations running multiple study types or requiring specialized workflows.
Core Features and Capabilities {#core-features}
DADOS AS provides a comprehensive suite of clinical research tools that handle everything from study design to final data export. Let’s examine the specific capabilities that make this platform effective for modern clinical research.
Electronic Case Report Forms (eCRFs)
The eCRF builder in DADOS AS uses a drag-and-drop interface that allows research teams to create sophisticated data collection forms without programming knowledge. You can build everything from simple questionnaires to complex multi-visit longitudinal studies with branching logic and conditional fields.
What sets DADOS AS apart is the built-in library of validated instruments. The platform includes standardized pain, functionality, and quality of life assessments, plus the complete PROMIS library of computer adaptive tests. This means you can deploy clinically validated instruments immediately rather than spending weeks creating and validating custom forms.
The system supports multiple question types including multiple choice, free text, date/time stamps, file uploads, and signature capture. Advanced features include automatic skip patterns, calculated fields, and real-time data validation rules that prevent common data entry errors.
Patient-Reported Outcomes (PROs)
One of DADOS AS’s strongest capabilities is patient-reported outcome collection. The platform provides both point-of-care data collection using tablets or kiosks, and remote completion through DADOS Connect, which allows patients to complete forms at home using any internet-connected device.
The PROMIS integration deserves special attention. Traditional patient-reported outcome measures can take 20-30 minutes to complete, leading to patient fatigue and incomplete data. DADOS AS uses computer adaptive testing to reduce completion time to 2-3 minutes while maintaining measurement precision. Each question is selected based on the patient’s previous responses, creating a personalized assessment experience.
For research teams, this means higher completion rates, better data quality, and reduced patient burden. For patients, it means spending more time with their healthcare team and less time filling out repetitive questionnaires.
Multi-Site Study Management
DADOS AS excels at managing complex multi-site studies through centralized administration tools. Study coordinators can track enrollment across sites, monitor data completion rates, and generate real-time reports showing study progress. The platform supports role-based permissions, allowing different levels of access for investigators, coordinators, monitors, and data managers.
The system includes robust subject tracking capabilities with automated reminder systems. Research teams can configure automatic email notifications for upcoming visits, overdue assessments, or protocol deviations. This proactive approach reduces lost-to-follow-up rates and improves protocol compliance.
Site management features include customizable dashboards showing key performance indicators, audit trails for all data changes, and integrated communication tools that facilitate coordination between central and site teams.
Data Integration and Export
DADOS AS recognizes that clinical research data doesn’t exist in isolation. The platform provides flexible data export options including CSV, Excel, and statistical software formats (SPSS, SAS, R). Advanced users can leverage API connections to integrate with external systems or create automated data pipelines.
The platform supports integration with electronic health record systems through DADOS Connect, reducing duplicate data entry burden on clinical sites. Laboratory data can be imported directly, eliminating transcription errors and speeding up data availability for analysis.
For regulatory submissions, DADOS AS generates audit trails and data lineage documentation that meets FDA and ICH-GCP requirements. The system maintains complete version control, allowing investigators to demonstrate data integrity throughout the study lifecycle.
DADOS AS vs Commercial EDC Platforms {#comparison}
Understanding how DADOS AS compares to expensive commercial alternatives helps research organizations make informed technology decisions. We’ll examine the key differences in functionality, cost, and implementation complexity.
Functionality Comparison
Data Collection Capabilities: DADOS AS matches or exceeds commercial platforms in core data collection features. The platform supports complex study designs, branching logic, calculated fields, and real-time validation. Where DADOS AS particularly excels is in patient-reported outcomes, with the PROMIS CAT integration providing capabilities that many commercial platforms charge extra for.
User Experience: Commercial platforms often prioritize sponsor needs over site usability. DADOS AS was designed by clinical researchers who understand site workflows. The result is an interface that research coordinators can learn quickly and patients find intuitive to use.
Customization: Enterprise EDC platforms typically require expensive professional services for customization. DADOS AS provides extensive configuration options through the user interface, and the open-source architecture allows unlimited customization for organizations with technical resources.
Cost Analysis
The total cost of ownership difference between DADOS AS and commercial platforms is substantial:
Commercial EDC Platforms:
- Initial setup: $25,000-$100,000+
- Annual licensing: $50,000-$500,000+
- Professional services: $1,000-$2,000 per day
- Training: $5,000-$15,000 per session
- Ongoing support: 20-25% of annual license fees
DADOS AS:
- Initial setup: $5,000-$25,000 (primarily consulting)
- Annual hosting: $2,000-$10,000
- Professional services: $500-$1,000 per day
- Training: Often included or minimal cost
- Ongoing support: Community-based or contract consulting
For a typical multi-site study, organizations can save 60-80% in total technology costs by choosing DADOS AS over commercial alternatives. These savings can be redirected to actual research activities rather than software licensing.
Implementation Timeline
Commercial Platforms: Typical implementation ranges from 3-9 months, requiring extensive project management, technical integration, and user training. The complexity often necessitates dedicated IT resources and external consultants.
DADOS AS: Implementation typically takes 2-8 weeks, depending on study complexity. The platform’s design simplicity and extensive documentation enable faster deployment with minimal technical overhead.
Vendor Lock-in Considerations
Commercial EDC platforms create significant vendor dependency. Your data, workflows, and team expertise become tied to a specific vendor’s ecosystem. Migration to alternative platforms requires substantial time, cost, and risk.
DADOS AS eliminates vendor lock-in through open-source architecture and standard data formats. Organizations maintain control over their technology destiny and can modify the platform as research needs evolve.
Implementation Guide and Best Practices {#implementation}
Successfully implementing DADOS AS requires careful planning and understanding of best practices developed by research organizations worldwide. Here’s a practical guide based on real-world implementations.
Pre-Implementation Planning
Study Requirements Analysis: Before diving into platform configuration, conduct a thorough analysis of your study requirements. Document all data collection instruments, visit schedules, user roles, and integration needs. This upfront planning prevents costly changes during implementation.
Team Preparation: Identify key team members who will serve as platform champions. These individuals should understand both the clinical protocol and basic technology concepts. Early champion training accelerates organization-wide adoption.
Infrastructure Assessment: Evaluate your current IT infrastructure and internet connectivity at all planned sites. DADOS AS requires reliable internet access, but the bandwidth requirements are minimal compared to other EDC platforms.
Platform Configuration
Study Setup: DADOS AS provides study templates that accelerate initial configuration. Start with the template closest to your study design, then customize as needed. The platform’s form builder uses intuitive drag-and-drop functionality that non-technical users can master quickly.
User Role Definition: Configure user roles based on your study team structure. DADOS AS supports granular permissions that can restrict access to specific forms, patients, or data fields. Plan these roles carefully to maintain data security while enabling efficient workflows.
Validation Rule Implementation: Build validation rules that catch common data entry errors in real-time. DADOS AS supports range checks, logical consistency rules, and cross-field validations that improve data quality without creating excessive user burden.
User Training Strategy
Phased Training Approach: Implement training in phases, starting with study team leaders and expanding to site personnel. DADOS AS provides comprehensive training materials, but organizations benefit from customizing training to their specific workflows.
Hands-On Practice: Create training databases that mirror your actual study design. Allow users to practice data entry scenarios they’ll encounter during the study. This practical approach builds confidence and identifies potential workflow issues.
Ongoing Support Systems: Establish clear escalation procedures for technical questions. DADOS AS has active community support, but organizations should designate internal super-users who can handle routine questions.
Quality Assurance Testing
User Acceptance Testing: Conduct thorough testing with actual site personnel using realistic data scenarios. Test all user roles, data entry pathways, and report generation capabilities. This testing phase often reveals workflow improvements that enhance long-term efficiency.
Performance Testing: Evaluate platform performance under realistic usage conditions. DADOS AS is designed for high reliability, but testing helps identify any site-specific connectivity or performance issues before study launch.
Security Testing: Validate that security controls and access restrictions work as configured. Test password policies, session timeouts, and data access restrictions to ensure compliance with institutional security requirements.
Go-Live Strategy
Pilot Site Approach: Consider starting with one or two sites before full deployment. This approach allows you to refine workflows and identify issues in a controlled environment. Successful pilot sites often become champions that help train additional sites.
Phased Rollout: For large multi-site studies, implement DADOS AS in phases rather than all sites simultaneously. This approach reduces risk and allows you to incorporate lessons learned from early sites.
Contingency Planning: Develop contingency procedures for potential technical issues. While DADOS AS maintains high reliability, having backup procedures ensures study continuity during any unexpected system downtime.
Pricing and Cost Analysis {#pricing}
Understanding the true cost of DADOS AS implementation helps organizations make informed budget decisions and compare alternatives effectively. The platform’s open-source nature creates a different cost structure compared to commercial EDC systems.
DADOS AS Cost Components
Platform Licensing: DADOS AS is open-source software, meaning there are no licensing fees for the software itself. Organizations can download, install, and modify the platform without paying licensing costs. This fundamental difference eliminates the largest cost component of commercial EDC platforms.
Hosting and Infrastructure: Organizations have two hosting options: self-hosting or managed hosting services. Self-hosting requires internal IT resources but provides maximum control and potentially lower costs. Managed hosting typically costs $2,000-$10,000 annually depending on study size and data volume.
Implementation Services: Most organizations benefit from professional implementation services, which typically cost $5,000-$25,000 depending on study complexity. These services include platform configuration, user training, and technical documentation. The investment usually pays for itself through faster deployment and fewer implementation errors.
Ongoing Support: DADOS AS provides community support through forums and documentation at no cost. Organizations requiring dedicated support can contract with implementation partners or the core development team. Typical support contracts range from $2,000-$10,000 annually.
Total Cost of Ownership Comparison
Small Single-Site Study (50-100 patients):
- DADOS AS: $5,000-$15,000 total
- Commercial EDC: $25,000-$75,000 total
- Savings: 70-80%
Medium Multi-Site Study (500-1,000 patients, 5-10 sites):
- DADOS AS: $15,000-$35,000 total
- Commercial EDC: $75,000-$250,000 total
- Savings: 75-85%
Large International Study (2,000+ patients, 20+ sites):
- DADOS AS: $35,000-$75,000 total
- Commercial EDC: $200,000-$500,000+ total
- Savings: 80-90%
Cost-Benefit Analysis
The cost savings from DADOS AS extend beyond direct software expenses. Research organizations report additional benefits including:
Reduced Training Costs: The platform’s intuitive design reduces training time by 50-70% compared to commercial alternatives. New site activation becomes faster and less expensive.
Lower Change Management Costs: Study amendments and protocol changes can be implemented quickly without expensive vendor change orders. This flexibility reduces study costs and timeline extensions.
Eliminated Vendor Dependencies: Organizations avoid ongoing licensing increases and vendor-imposed upgrade costs that plague commercial platform users.
Redirected Budget to Research: Cost savings can be reinvested in actual research activities rather than software licensing, potentially improving study outcomes and scientific impact.
Budget Planning Recommendations
Initial Implementation: Budget 15-25% of total study technology costs for DADOS AS implementation, compared to 40-60% for commercial platforms. The reduced technology overhead allows greater investment in data collection and analysis activities.
Ongoing Costs: Plan for annual technology costs of 2-5% of total study budget, compared to 8-15% for commercial EDC platforms. This predictable cost structure simplifies multi-year budget planning.
Scaling Considerations: DADOS AS costs scale efficiently with study growth. Adding sites or extending study duration doesn’t trigger significant licensing increases, unlike commercial platforms that often impose per-site or per-patient fees.
Security and Compliance Framework {#security}
Clinical research data requires the highest levels of security and regulatory compliance. DADOS AS implements comprehensive security measures that meet or exceed industry standards for clinical research platforms.
Data Security Architecture
Encryption Standards: DADOS AS uses Advanced Encryption Standard (AES) 256-bit encryption for data at rest and TLS 1.3 encryption for data in transit. These enterprise-grade encryption standards ensure that patient data remains protected even if unauthorized access occurs to storage systems or network traffic.
Access Controls: The platform implements role-based access control (RBAC) with granular permissions that can restrict access to specific forms, patients, or data fields. Organizations can define custom roles that match their study team structure and data governance requirements.
Authentication Systems: DADOS AS supports multi-factor authentication (MFA) and integrates with institutional single sign-on (SSO) systems. Password policies are configurable to meet institutional security requirements, including complexity rules and expiration schedules.
Audit Trails: Every user action is logged with timestamps, user identification, and change details. This comprehensive audit trail capability meets FDA 21 CFR Part 11 requirements and supports regulatory inspection preparations.
Regulatory Compliance
HIPAA Compliance: DADOS AS includes technical, administrative, and physical safeguards required for HIPAA compliance. The platform generates business associate agreements (BAAs) and provides documentation supporting covered entity compliance programs.
FDA 21 CFR Part 11: The platform implements electronic signature capabilities, audit trails, and data integrity controls required for FDA submissions. System validation documentation supports regulatory submission requirements.
ICH-GCP Compliance: DADOS AS supports Good Clinical Practice guidelines through features like investigator delegation logs, protocol deviation tracking, and source data verification capabilities.
International Standards: The platform accommodates international privacy regulations including GDPR, PIPEDA, and local data protection requirements through configurable privacy controls and data retention policies.
Data Backup and Disaster Recovery
Automated Backups: DADOS AS performs automated daily backups with configurable retention periods. Backup data is encrypted and stored in geographically separate locations to ensure availability during disasters.
Recovery Procedures: The platform includes documented disaster recovery procedures with recovery time objectives (RTO) of less than 4 hours and recovery point objectives (RPO) of less than 1 hour for most deployment configurations.
Business Continuity: High-availability deployment options ensure platform accessibility during planned maintenance or unexpected outages. Multiple redundant systems prevent single points of failure.
Security Monitoring and Incident Response
Continuous Monitoring: DADOS AS includes security monitoring capabilities that detect unusual access patterns, failed login attempts, and potential security threats. Automated alerts notify administrators of security events requiring investigation.
Incident Response: The platform includes incident response procedures for security breaches, data integrity issues, and system availability problems. These procedures align with institutional incident response policies and regulatory reporting requirements.
Vulnerability Management: Regular security assessments and penetration testing ensure that platform security remains current with evolving threat landscapes. Security patches are applied promptly to maintain protection levels.
Real-World Case Studies and Results {#case-studies}
Understanding how research organizations successfully implement DADOS AS provides practical insights for planning your own deployment. These case studies represent actual implementations across different study types and organizational contexts.
Case Study 1: Orthopedic Surgery Registry
Organization: Major academic medical center orthopedic department Study Type: Prospective patient registry with 2,000+ patients annually Implementation Timeline: 6 weeks
Challenge: The department was using paper forms and spreadsheets to track patient outcomes, creating data quality issues and limiting research capabilities. Manual data entry consumed 3-4 hours daily for research staff.
DADOS AS Solution: Implemented comprehensive patient-reported outcome collection using PROMIS instruments integrated with clinical data collection. Patients complete forms on tablets during clinic visits or at home using DADOS Connect.
Results:
- 85% reduction in data entry time
- 40% improvement in patient completion rates
- 95% data completeness compared to 70% with paper forms
- Enabled publication of 12 research papers in first two years
- $150,000 annual savings compared to commercial EDC options
Key Success Factors: Strong physician champion support, dedicated implementation team, and phased rollout starting with one clinic before expanding department-wide.
Case Study 2: Multi-Site Clinical Trial
Organization: Small biotech company Study Type: Phase II randomized controlled trial, 8 sites, 200 patients Implementation Timeline: 4 weeks
Challenge: Limited budget for EDC platform ($25,000 annually) but needed full clinical trial capabilities including randomization, adverse event reporting, and regulatory compliance features.
DADOS AS Solution: Configured platform for multi-site randomized trial with integrated adverse event reporting, electronic source data capture, and automated safety monitoring alerts.
Results:
- Completed study 6 weeks ahead of schedule
- Zero critical data queries during regulatory inspection
- 99.5% data completeness at database lock
- Total EDC costs under $15,000 for entire study
- Successful FDA submission with no data integrity questions
Key Success Factors: Extensive user acceptance testing, comprehensive site training program, and dedicated study coordinator support during initial patient enrollment.
Case Study 3: International Collaborative Study
Organization: Academic research consortium across 3 countries Study Type: Observational study, 15 sites, 1,500 patients Implementation Timeline: 8 weeks
Challenge: Complex international collaboration requiring multilingual support, varying internet connectivity, and different regulatory environments across participating countries.
DADOS AS Solution: Deployed cloud-hosted instance with multilingual forms, offline data collection capabilities, and country-specific privacy controls to accommodate different regulatory requirements.
Results:
- Successful data collection across all international sites
- 92% patient completion rate despite varying technological infrastructure
- Streamlined data sharing agreements using platform security documentation
- Published high-impact research results 18 months earlier than originally projected
- Established framework for ongoing international collaborations
Key Success Factors: Early engagement with international collaborators, flexible platform configuration to accommodate local requirements, and comprehensive technical support during initial deployment.
Case Study 4: Quality Improvement Initiative
Organization: Hospital system quality department Study Type: Continuous quality monitoring across 12 departments Implementation Timeline: 3 weeks
Challenge: Needed to track quality metrics across multiple departments with varying technical capabilities and existing workflows.
DADOS AS Solution: Implemented department-specific dashboards with automated data collection from existing systems and manual entry for metrics not available electronically.
Results:
- Real-time quality metric visibility across all departments
- 60% reduction in quality reporting preparation time
- Improved identification and response to quality issues
- Enhanced regulatory compliance demonstration capabilities
- Foundation for expanding quality monitoring enterprise-wide
Key Success Factors: Department champion network, integration with existing quality management processes, and focus on workflow enhancement rather than technology for its own sake.
Integration with Existing Systems {#integration}
Modern clinical research occurs within complex technology ecosystems. DADOS AS provides flexible integration capabilities that allow seamless connectivity with existing institutional systems and research tools.
Electronic Health Record Integration
DADOS Connect EHR Integration: One of DADOS AS’s most valuable capabilities is integration with electronic health record systems. This integration reduces duplicate data entry burden on clinical sites while improving data accuracy and completeness.
The platform can pull patient demographic information, laboratory results, vital signs, and medication lists directly from EHR systems. This automatic data population reduces site workload and eliminates transcription errors that commonly occur when manually transferring clinical data.
Implementation Considerations: EHR integration requires coordination with institutional IT departments and may involve HL7 FHIR interfaces or custom API development. Organizations should plan 4-8 weeks for integration development and testing.
Security and Compliance: All EHR integrations maintain strict security controls and audit trails. Patient consent requirements and data use agreements must be carefully managed to ensure compliance with institutional policies and regulatory requirements.
Laboratory Information Systems
Automated Lab Data Import: DADOS AS can integrate with laboratory information management systems (LIMS) to automatically import laboratory results. This capability is particularly valuable for studies requiring frequent laboratory monitoring or complex biomarker analyses.
The platform supports standard laboratory data formats including HL7 messages and laboratory-specific data exports. Automated import eliminates manual transcription errors and ensures rapid availability of laboratory results for clinical decision-making.
Data Validation: Imported laboratory data undergoes automatic validation checks including normal range verification, trend analysis, and protocol-specific alert thresholds. These capabilities support safety monitoring and protocol compliance requirements.
Clinical Trial Management Systems
CTMS Integration: Organizations using clinical trial management systems can integrate DADOS AS for seamless data flow between patient enrollment, visit scheduling, and data collection activities.
Integration typically involves sharing patient identifiers, visit schedules, and enrollment status between systems. This connectivity ensures that data collection activities remain synchronized with overall trial management workflows.
Regulatory Documentation: Integrated systems can share regulatory documentation including informed consent status, protocol deviation logs, and audit trail information. This comprehensive documentation support simplifies regulatory compliance and inspection preparation.
Statistical Analysis Software
Direct Data Export: DADOS AS provides direct export capabilities for major statistical analysis platforms including SAS, SPSS, R, and Stata. Exported data includes comprehensive metadata and audit trail information required for regulatory submissions.
API Access: Advanced users can leverage RESTful APIs to create automated data pipelines that update analysis datasets in real-time. This capability supports adaptive trial designs and interim analysis requirements.
Version Control: The platform maintains complete version control for all data exports, ensuring that analysis teams can track data changes and maintain analytical reproducibility throughout the study lifecycle.
Implementation Best Practices
Phased Integration Approach: Implement integrations incrementally, starting with the most critical connections and adding complexity over time. This approach reduces implementation risk and allows teams to gain experience with simpler integrations before tackling complex multi-system connectivity.
Testing and Validation: Thoroughly test all integrations using realistic data scenarios. Validate data accuracy, error handling, and performance under normal and peak usage conditions.
Change Management: Develop procedures for managing integration changes, including version updates, security patches, and system modifications. These procedures ensure that integrations remain functional as connected systems evolve.
Support and Training Resources {#support}
Successful DADOS AS implementation depends on comprehensive support and training resources. The platform provides multiple support channels and learning resources designed to accelerate user adoption and ensure long-term success.
Official Support Channels
Community Forums: DADOS AS maintains active community forums where users share experiences, ask questions, and collaborate on platform improvements. These forums provide peer-to-peer support and serve as repositories for implementation best practices.
Documentation Library: Comprehensive documentation covers all aspects of platform configuration, use, and administration. Documentation includes step-by-step guides, video tutorials, and troubleshooting resources that support self-service problem resolution.
Direct Developer Support: Organizations can contract directly with the DADOS AS development team for technical support, custom development, and advanced implementation assistance. This support provides access to the platform’s creators and ensures authoritative problem resolution.
Training Programs
User Training: DADOS AS provides role-based training programs for different user types including investigators, research coordinators, data managers, and system administrators. Training materials are available in multiple formats including video tutorials, interactive guides, and hands-on workshops.
Administrator Training: Specialized training for system administrators covers platform configuration, security management, backup procedures, and integration development. This training ensures that organizations can maintain and customize their DADOS AS installations independently.
Train-the-Trainer Programs: Organizations implementing DADOS AS across multiple sites benefit from train-the-trainer programs that prepare internal champions to provide ongoing user education and support.
Implementation Services
Professional Services: Implementation partners provide comprehensive services including requirements analysis, platform configuration, user training, and go-live support. These services accelerate implementation timelines and reduce the risk of deployment issues.
Custom Development: Organizations requiring specialized functionality can engage development partners for custom modifications, integration development, or advanced reporting capabilities. The open-source architecture enables unlimited customization possibilities.
Ongoing Consulting: Many organizations benefit from ongoing consulting relationships that provide strategic guidance, performance optimization, and assistance with platform evolution as research needs change.
Self-Service Resources
Knowledge Base: Comprehensive knowledge base articles cover common questions, configuration procedures, and troubleshooting steps. The knowledge base is searchable and regularly updated based on user feedback and platform evolution.
Video Library: Extensive video library provides visual demonstrations of platform features, configuration procedures, and best practices. Videos are organized by user role and experience level to support targeted learning.
Webinar Series: Regular webinars cover platform updates, advanced features, and implementation best practices. Recorded webinars are available for on-demand viewing and can be used for ongoing staff training.
Quality Assurance Support
Validation Documentation: DADOS AS provides comprehensive validation documentation that supports regulatory compliance and quality assurance requirements. This documentation reduces the burden on organizations to develop validation materials independently.
Testing Resources: Pre-built testing scenarios and validation checklists help organizations conduct thorough user acceptance testing and quality assurance validation. These resources ensure comprehensive testing coverage and reduce the risk of post-implementation issues.
Compliance Guidance: Specialized guidance documents help organizations navigate regulatory compliance requirements including HIPAA, FDA 21 CFR Part 11, and ICH-GCP. This guidance accelerates compliance validation and reduces regulatory risk.
Future Roadmap and Updates {#roadmap}
Understanding DADOS AS’s development roadmap helps organizations plan long-term technology strategies and ensure their platform investments remain current with evolving clinical research needs.
Planned Feature Enhancements
Artificial Intelligence Integration: Future DADOS AS releases will incorporate AI-powered features including automated data quality monitoring, predictive analytics for patient enrollment, and intelligent form optimization based on completion patterns.
These AI capabilities will help research teams identify potential data quality issues before they impact study integrity, predict and prevent patient dropout, and optimize data collection workflows based on real-world usage patterns.
Enhanced Mobile Capabilities: Mobile-first design improvements will provide native mobile applications for iOS and Android platforms, enabling offline data collection and synchronization. These capabilities will be particularly valuable for field studies and environments with limited internet connectivity.
Advanced Analytics Dashboard: Built-in analytics capabilities will provide real-time study performance metrics, enrollment tracking, and data quality indicators without requiring external reporting tools. These dashboards will include configurable alerts and automated reporting features.
Technology Evolution
Cloud-Native Architecture: Future platform versions will leverage cloud-native technologies including containerization and microservices architecture. These improvements will enhance scalability, reliability, and deployment flexibility while reducing infrastructure requirements.
API Expansion: Enhanced API capabilities will support deeper integration with emerging healthcare technologies including wearable devices, remote monitoring systems, and digital therapeutics platforms. These integrations will enable more comprehensive data collection and patient engagement strategies.
Blockchain Integration: Exploratory development includes blockchain-based audit trails and data integrity verification. These capabilities will provide enhanced security and regulatory compliance features for high-stakes clinical research applications.
Regulatory Compliance Updates
Emerging Regulations: DADOS AS development actively tracks emerging regulatory requirements including updated FDA guidance on electronic systems, evolving international privacy regulations, and new clinical research standards.
The platform will incorporate compliance features as regulations evolve, ensuring that organizations remain compliant without requiring expensive system upgrades or migrations.
Standards Adoption: Future releases will incorporate emerging healthcare data standards including FHIR R4, CDISC CDASH updates, and HL7 clinical research specifications. These standards will improve interoperability and reduce implementation complexity.
Community-Driven Development
Open Source Contribution: The platform’s open-source nature enables community contributions that accelerate feature development and ensure that enhancements address real-world user needs rather than commercial priorities.
Organizations can contribute feature requests, code improvements, and integration examples that benefit the entire DADOS AS community. This collaborative development model ensures continuous platform evolution aligned with user requirements.
User Advisory Board: Active user advisory board provides strategic guidance for platform development priorities and ensures that future enhancements address the most pressing needs of the clinical research community.
Long-Term Sustainability
Institutional Support: Strong institutional backing from the University Health Network and growing adoption by major research organizations ensures long-term platform sustainability and continued development investment.
Commercial Ecosystem: Growing ecosystem of implementation partners, hosting providers, and specialized service companies provides sustainable business models that support ongoing platform development and user support.
Academic Partnerships: Partnerships with academic institutions and research organizations provide ongoing funding and development resources that ensure platform evolution continues to meet evolving research needs.
Frequently Asked Questions {#faq}
What is DADOS AS and how does it differ from commercial EDC platforms?
DADOS AS (Data Driven Outcome System) is an open-source electronic data capture platform specifically designed for clinical research and patient-reported outcomes. Unlike commercial EDC platforms that can cost $50,000-$500,000+ annually, DADOS AS provides comparable functionality at 70-90% lower total cost. The platform was developed by clinicians at University Health Network, ensuring it addresses real-world research workflow challenges rather than generic software requirements.
How much does DADOS AS cost compared to commercial alternatives?
DADOS AS typically costs 70-90% less than commercial EDC platforms. For a medium multi-site study (500-1,000 patients), total costs range from $15,000-$35,000 compared to $75,000-$250,000 for commercial solutions. The open-source nature eliminates licensing fees, with costs limited to hosting ($2,000-$10,000 annually) and optional implementation services ($5,000-$25,000).
Is DADOS AS compliant with FDA and regulatory requirements?
Yes, DADOS AS meets FDA 21 CFR Part 11, HIPAA, PIPEDA, and ICH-GCP compliance requirements. The platform includes electronic signatures, comprehensive audit trails, data encryption, and validation documentation required for regulatory submissions. Over 700 studies have used DADOS AS successfully for regulatory compliance, including FDA submissions.
How long does DADOS AS implementation typically take?
DADOS AS implementation typically takes 2-8 weeks depending on study complexity. Simple studies can be configured in 2-3 weeks, while complex multi-site trials may require 6-8 weeks. This is significantly faster than commercial EDC platforms, which typically require 3-9 months for implementation.
Can DADOS AS integrate with our existing systems?
Yes, DADOS AS provides flexible integration capabilities with EHR systems, LIMS, CTMS, and statistical software. The platform supports HL7 FHIR interfaces, RESTful APIs, and standard data formats. Integration with electronic health records through DADOS Connect reduces duplicate data entry and improves data accuracy.
What kind of support is available for DADOS AS?
DADOS AS provides multiple support channels including community forums, comprehensive documentation, video tutorials, and professional consulting services. Organizations can access free community support or contract with implementation partners for dedicated support. The development team also provides direct support for complex technical issues.
Is DADOS AS suitable for small research studies?
Yes, DADOS AS is particularly well-suited for small research studies and investigator-initiated trials. The platform’s low cost and quick implementation make sophisticated EDC capabilities accessible to studies with limited budgets. Many single-site studies implement DADOS AS for under $10,000 total cost.
How does DADOS AS handle patient-reported outcomes?
DADOS AS excels at patient-reported outcome collection through integrated PROMIS computer adaptive testing (CAT) tools. These tools reduce patient completion time from 30 minutes to 2-3 minutes while maintaining measurement precision. Patients can complete forms on tablets during visits or at home using DADOS Connect.
What happens if we need custom features not available in DADOS AS?
The open-source architecture allows unlimited customization for organizations with technical resources. Implementation partners can develop custom features, integrations, or specialized workflows. Unlike commercial platforms, customizations don’t require expensive vendor change orders or ongoing licensing fees.
Can we migrate from our current EDC platform to DADOS AS?
Yes, organizations can migrate from commercial EDC platforms to DADOS AS. The migration process involves data export from existing systems, platform configuration, and user training. Many organizations migrate to escape vendor lock-in and reduce ongoing technology costs while maintaining or improving functionality.
Transform Your Clinical Research with DADOS AS
The evidence is clear: DADOS AS delivers enterprise-level clinical research capabilities at a fraction of commercial platform costs. With over 700 successful study implementations, 99.7% uptime reliability, and 70-90% cost savings, this platform represents a paradigm shift in how research organizations approach electronic data capture technology.
Here’s your action plan for getting started:
Week 1-2: Evaluate your current EDC costs and requirements against DADOS AS capabilities. Download platform documentation and explore the demo environment to understand the user experience.
Week 3-4: Engage with implementation partners or the development team to discuss your specific study requirements and receive customized implementation recommendations.
Week 5-8: Complete platform implementation, user training, and quality assurance testing based on your study timeline and complexity.
Month 2-3: Launch your study with confidence, knowing you have access to comprehensive support resources and a platform designed by clinicians for clinical research success.
The clinical research landscape is evolving rapidly, and organizations that leverage cost-effective, flexible technology solutions gain competitive advantages in study execution and data quality. DADOS AS provides the foundation for this technological transformation while maintaining the highest standards of security, compliance, and reliability.
Your research deserves better than expensive, inflexible commercial platforms that prioritize vendor profits over research success. DADOS AS puts clinical research needs first, providing the tools and capabilities that research teams actually need at costs that make sense for modern research budgets.
Ready to transform your clinical research capabilities? Contact the DADOS AS team today to schedule a personalized demonstration and implementation consultation tailored to your specific research requirements.
