SpherePX
Patients at the Heart of Decision-Making
Real-World Evidence, Grounded in Real Patient Lives
Learn how one of the world’s top cancer research institutes, Gustave Roussy, has integrated Alira Health’s SpherePX technology into Project Interception to advance cancer prevention.
Introducing SpherePX™: The Patient-Enabled Platform for Real-World Evidence
A flexible, modular solution, SpherePX streamlines the design, launch, and execution of post-market studies — delivering meaningful, real-time evidence grounded in patient experience.
Key Differentiators
- Designed around patient experience
- Regulatory-grade data
- Fully interoperable
Platform Benefits
- Reduced operational complexity
- Accelerated deployment
- Higher-quality insights
Key Differentiators
- Designed around patient experience
- Regulatory-grade data
- Fully interoperable
Platform Benefits
- Reduced operational complexity
- Accelerated deployment
- Higher-quality insights
Today’s Studies Need to Be Faster, Smarter — and Human
Payers, regulators, and providers want compliance — and context.
What defines high-impact post-market studies:
- Patient engagement that improves retention and data quality
- Evidence grounded in real-world clinical practice
- Insights that span care settings and diverse populations
- Flexibility to support PASS, LTFU, CER, registries, and hybrid designs
Bridging the Real-World Evidence Gap
Even with better platforms and regulatory openness, most post-market studies still fall short.
- Fragmented data across settings and systems
- Low patient engagement and retention
- Evidence that lacks regulatory and payer-grade rigor
The opportunity isn’t more data — it’s the right data: connected, contextual, and patient-centered.
One Platform. Flexible Across Study Models.
Ready in weeks, not months.
SpherePX adapts to your evidence strategy — supporting standalone, hybrid, or longitudinal designs across all phases of the product lifecycle.
Study Types Supported
- Regulatory-grade registries
- Post-Authorization Safety Studies (PASS)
- Long-Term Follow-Up (LTFU)
- Comparative Effectiveness Research (CER)
- Hybrid studies for feasibility, value, and access
- Label expansion and reimbursement support
SpherePX Captures Evidence Where it Matters
In environments where patients live and care happens.
| Approachable Design | Flexible and Multi-Setting | Scalable and Submission-Ready |
|---|---|---|
| Mobile-first, multilingual, literacy-aware | Modular design fits study needs and geographies | Designed for rapid localization and high-volume enrollment |
| Seamless and intuitive onboarding | Works across clinic, home, long-term care, and virtual care | Aligned with global regulatory submission standards |
| Patient- and provider-facing tools | Dynamic workflow and content builder (CMS) | Supports access, medical affairs, and regulatory use |
Most platforms ask patients to adapt. SpherePX adapts to them.
Management Capabilities
Configure Studies Quickly, With Customization
Reduce complexity
Use intuitive tools that let teams focus on what matters most
Accelerate set-up and deployment
Launch quickly with a flexible, no-code platform — even mid-study
Scale with confidence
Grow across studies, sites, and geographies without disruption
Core Features
- Workflow Builder
Automate study steps and logic-based actions - Content Builder
Configure eCRFs, ePROs, educational modules, and more - Site and User Management
Assign roles, set permissions, and manage configurations - Consent and Legal Management
Customize study-specific consent workflows - Localization
Deliver translated content across all modules - Safety Alerts for Adverse Events
Monitor safety through built-in pharmacovigilance tools
Monitoring Capabilities
Real-Time Oversight to Keep Studies on Track
Reduce administrative burden
Automate documentation and workflows so teams can focus on care
Streamline patient management
Automate documentation and workflows so teams can focus on care
Access real-time data
Monitor study performance and patient input as it’s captured
Core Features
- Patient lists
View patient status at-a-glance - Eligibility scoring and pathway assignments
Assign patients to tailored pathways using automated logic - Data entry and modification
Edit, manage, and review eClinROs, eCRFs, and ePROs - Patient Profile and Visit Management
Access complete patient records and visit history in one place - Personalized Disease Management Plan
Create and update custom management plans directly in the app - Monitoring Tools
Build dashboards, set alerts, and generate custom reports
Patient Experience Capabilities
Built for Engagement and Retention
Personalized for every patient
Tailored to the needs of each study and population
Intuitive for all users
Designed for any level of digital experience or literacy
Empowering patients through insight
Supports informed decisions with built-in education modules
Core Features
- Custom Onboarding Flows
Guide patients through setup with AI-driven support to reduce drop-off - Adaptive Questionnaires
Capture study-specific input through tailored ePROs and eDiaries - eConsent/ eSignature
Enable secure, remote document signing through digital workflows - Behavior-Based Notifications
Deliver personalized reminders based on individual activity - Integrated Support and Education Hub
Provide AI-guided help, condition-specific content, and legal info - Patient Compensation
Offer incentives to increase study participation and engagement - EMR Integration
Allow patients to link and share medical records securely - Dynamic Home Page
Prioritize next steps to reduce cognitive burden
An AI Assistant Feature Suite for All Users
Transform how you capture, manage, and act on study data using AI you build to fit your workflows with our integrated AI Assistant Creator
For Study Administrators
- Build Custom AI Assistants
Quickly create AI assistants using tailored prompts and uploaded study documents. - Targeted AI deployment
Decide exactly where and how each assistant functions.- Attach a specific assistant to an individual question, entire questionnaire, or place an informational chatbot on the study landing page.
- Smart Access to Study Insights
Enable real-time answers to queries about your study or participants pulled from pre-defined fields in your study database or connected systems.
For Patients and Clinicians
- Conversational Study Support
Give users instant answers about the study through a conversational chat interface with an AI assistant trained on your protocol. - AI-enhanced questionnaires
Attach an AI assistant that listens to dictation, transcribes the output, interprets the meaning using your AI model, and maps the output directly to structured eCRF fields. - Automated data extraction
Pre-populate forms with data extracted from
medical records .
Proven Market Expertise
Trusted across studies, geographies, and populations.
Built on real-world needs and real results.
Case Study
Prospective, Multi-Center Colorectal Study
Description and Objectives
Design and deploy a Virtual Site to compare a stool DNA test for colorectal cancer (CRC) to colonoscopy. This study was a prospective, cross-sectional, multi-center study and expected to enroll approximately 12,500 patients to ensure at least 60 pathologically confirmed CRC cases with a valid stool DNA test.
With the following objectives to:
- Provide a Virtual Site that supported all stages of the trial
- EDC data integration
- Improve patient-centricity by offering a more flexible and convenient option to patients through our digital solution – making retention, data collection and study-related communication much easier
Key Activities
Solution Scoping, Design and Development
Launch virtual arm of clinical trial
- Patient app: study enrollment/onboarding, eConsent, data collection, patient engagement and retention, study closeout
- Real-time study management platform: patient monitoring dashboards, alerts, AE monitoring, IP delivery setup, data transfer
Key Facts and Results
- Sole virtual site deployed
- 5000+ app downloads (pre-screening leads)
- 1200+ successfully enrolled patients
- 2nd highest contributing site to the discovery of confirmed CRC cases
Case Study
Migraine Pregnancy Registry
Description and Objectives
The primary objective of this registry is to compare the frequency of major congenital malformations (MCMs) among prospectively enrolled women with migraine exposed to the Sponsor’s drugs during pregnancy with 2 unexposed comparator groups: prospectively enrolled women with migraine (treated or untreated), and women without migraine.
A secondary objective of the study is to assess the treatment decision-making process of physicians, and their understanding of the patient experience.
Key Activities
Solution Scoping, Design and Development
- Protocol development
- Recruitment, digital screening, enrollment, engagement
- Structured data collection through ePROs
- Data management, data reporting
Key Facts and Results
- This study will provide critical data to satisfy FDA post-marketing requirements and guide safe usage recommendations
- The registry will collect and analyze data on the effects of the sponsor’s drugs during pregnancy, contributing to a deeper understanding of its safety profile
- Insights from the study will support healthcare providers in making informed decisions about migraine treatment during pregnancy, potentially improving maternal and infant
health outcomes
The factors driving success include building on the success of past registries to rapidly implement study template, allowing for faster start-up and launch; patient compensation to drive engagement as we steadily recruit and onboard new patients; and with strong communication and sponsor support, driving mid study updates managed in due time and planned budget, following FDA regulations.
Case Study
Real-World Impact: A Global Study on Lupus Treatment Effectiveness
Description and Objectives
Evaluate the real-world effectiveness of adding the sponsor’s drug to standard SLE* care, focusing on clinical outcomes and skin manifestations. The project captures unique data on medication use through standardized assessments and patient diaries, enabling valuable insights for stakeholders.
Key Activities
Use a conversational app to make data collection more engaging and approachable, with an adaptive language tree that changes based on the user’s motivation and persona.
Key Facts and Results
The factors driving success include a user-friendly application—reducing decision fatigue, promoting adherence, and delivered in multiple languages across nine countries; and strong partner support, dedicated to monitoring by leveraging our real-time dashboards.
Case Study
Disease Management in Cancer
Description and Objectives
Partnering with a hospital in France to develop personalized prevention in people at high risk of cancer. Cancer interception relies on a combination of early detection and prevention/ treatment to eradicate cancers before their clinical phase.
The objective of the program is to reduce the risk of stage 2 or higher (or equivalent) malignant tumors by 30% over 5 years in participants, by identifying people at increased risk of cancer as early as possible, and offering them a personalized course of screening and prevention of the disease.
Key Activities
Solution Scoping, Design and Development
- Co-design the solution with the Hospital experts (app and
web-based) - Patient Pathways: Personalized risk-based pathways, care-plans, appointment booking, follow-up, etc.
- Algorithms (scores) and interoperability with EMR/EHR (upcoming)
Key Facts and Results
The 2 main factors contributing to success are: 1) focusing on what was previously unable to be done effectively, i.e. follow up with the participant after the visit by providing them with a prevention plan and personalized follow-up and 2) dramatically reducing administrative burden on HCPs by providing a single unified platform, where previously multiple systems and paper documentation was being utilized.
Enterprise-Ready and Globally Compliant
SpherePX meets the highest standards for data protection, interoperability, and multi-market execution.
- Multi-country and multi-language support
- Role-based access controls and audit trail tracking
- HL7 FHIR-compatible for EMR integration
- ISO 27001-aligned hosting infrastructure
- 21 CFR 11 and GDPR compliant
- Built-in localization for patients, investigators, and sponsors
- IEC 62304: framework for medical device software life cycle processes
- Cyber-security and Pen-Testing
- Alira Health‘s global internal QMS
More Than a Platform. A Strategic Partner.
SpherePX is embedded within Alira Health’s evidence ecosystem — where strategy, science, and software work together.
- Evidence generation strategy
- Regulatory and payer engagement
- End-to-end data management
and reporting
Beyond the platform — you’re gaining a partner who understands the science, the strategy, and the people behind every study.
- A patient-driven digital ecosystem supporting decentralized trials, RWE generation, and patient support programs.
- 150,000+ enrolled patients worldwide, fostering inclusivity and diversity in life sciences.