The EmpiraMed Framework
Our Products
Our Decentralized Study Applications
- Clinical Trials for Regulatory Approvals
- New Drugs, New Indications, or Label Expansion
- Reduce Costs, Expand Patient Access, and Shorten Time to Market
- Post Market Observational Studies to Measure RW Patient Experience
- Treatment Satisfaction, Symptoms, QoL, ADL, Mobility, HCU, and Work Productivity
- Comparative Effectiveness for Prescribers & Payors; Feedback Loop to Manufacturer R&D
- Post Market Required Phase IV Studies
- Reduce Clinic Burden by Leveraging Patient Self Reporting, EHR Integration, Uploaded Patient Medical Records, Clinic Forms, Claims, and Specialty Pharmacy Refill Data
- Real Time AE Management, Safety Studies, and REMS
- 24X7 On-Demand Data Reporting and Analysis
- Drug and Disease Registries including Rare Disease Registries
- Natural History of Disease; Longitudinal Treatment Effectiveness and Symptom Impact
- Partnerships with Patient Advocacy Groups
- Outcomes Based Contracting Programs
- Feedback Loop to Manufacturers and Payors for OBC Implementation beyond Claims Data
- Quality Improvement Intervention Projects
- Medication Adherence Measurement to Train Intervention Algorithms
- Adherence Improvement by Reminders, Education, and Call Center Interventions
Your Results
Learn More about our Remarkable Engagement Statistics
Localization & Internationalization
A more detailed look at our Globalization efforts according to the I18N and L10N Standards.
- Full “Left-to-Right” (LTR) Language Internationalization
- Complete Localization
- Regional Language Formats and Dialects
- Local Numbers, Dates, Special Characters, and Currencies
- Regionalized Rewards Program Rules, eGifts, and Currencies
- General Data Protection Regulation 2016/679 (GDPR) Compliance
- International Compliance Practices Overseen by Goodwin Procter LLP
- Language Translation Configuration
- Certified Translation - Library of Validated, Fully Accurate Languages
- Automated Translation - Generate Any LTR Language in Minutes!
- Language Translation Execution
- Dynamic and Fully Automated
- Personalized to Patients by User’s Browser Defaults, User Selection, or PRS Assignment
- Multiple Languages and Rewards Supported Simultaneously in Same Study or Geography
- For Example: Some Users Residing in Country “A” See Language from Country “B” and Redeem eGifts in Currency from Country “A,” Euros, USDs, et al
Security & Compliance
We understand that in the healthcare industry there's no room for error when it comes to security, the privacy of patients, and the integrity of your data. That's why we partner with the best healthcare technology service providers, and maintain full compliance with the regulations and best practices required to protect patient data.
EmpiraMed complies with the following:
- IT Infrastructure
- Server-Side Software-as-a-Service Environment for Centralized Control
- All PHI Encrypted In and Never Leaves PRO Portal Application
- Secure User Access and PHI Authorized Access Lists
- Separated Development, Test, and Production Server Clusters
- Isolated Patient Application, Site Operations, and Database Production Servers by Client Study
- SSL Encryption and Configurable Two Factor Authentication (TFA)
- IQ/OQ/PQ Procedures
- High Security ISO/SSAE-16 Data Center
- Full HIPAA and GDPR Compliance
- Qualified Rewards Program with eCommerce and Auto-Fulfillment System for HIPAA and Corporate Integrity Compliance
- Clinic BAAs for Management of HIPAA-Compliant PHI and Electronic Health Records
- GCP Compliant SOPs for EmpiraMed Prime Contractor Services
- Quality System Statutory Compliance:
- 45 CFR Part 160/162/164 for Protection of PHI
- General Data Protection Regulation (EU) 2016/679
- ICH E6 R2 Good Clinical Practices (GCP)
- 21 CFR Part 11 for FDA Systems Validation
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Secure Responsive Web Design for Full Device Independence
