Decentralized Trials

Mushroom Solutions' Decentralized Trials platform is an end-to-end solution designed to bring clinical research directly to participants, eliminating the geographic and logistical barriers that prevent up to 70% of potential participants from accessing traditional research sites. By integrating eCOA, ePRO, Virtual Visits, Device Integration, and EHR connectivity into a single unified platform, it enables sponsors, CROs, and research sites to accelerate enrollment timelines, enrich data quality, and maintain full regulatory compliance across both fully decentralized and hybrid trial models.

The platform is built around a single source of truth for all remote and site activities, ensuring operational agility, participant-centric design, and audit-ready data integrity from Day 1. It is purpose-built for life sciences organizations seeking to modernize clinical operations, reduce site burden, and reach more representative patient populations globally.

Electronic Clinical Outcome Assessments (eCOAs)

• Global Assessment Form to evaluate overall health status, symptoms, and treatment response.
• Behavioral Observation Questionnaire Form to track and rate specific behavioral indicators.
• Medication Compliance Form to monitor participant adherence to dosing schedules.
• Clinician-Administered Quality of Life (QoL) Questionnaire assessing physical health, psychological well-being, and social functioning.
• Adverse Event Observation Form to track the relationship between the study drug or procedure and any reported adverse events.

eClinRo Assessments

• 6-Minute Walk Test (6MWT) Questionnaire to assess walking ability and gather pre- and post-walk feedback.
• Cognitive Performance Form testing concentration, memory, and executive functioning.
• Functional Mobility Assessment Form tracking basic mobility activity performance.
• Physical Activity Tracking Questionnaire monitoring activity frequency and comfort levels.
• Timed Up and Go (TUG) Test Assessment Form for qualitative evaluation of gait, turning, and sitting under timed constraints.
• Hand Grip Strength Assessment Form for qualitative grip strength measurement and inspection of underlying conditions.

ePerfO and ePRO Capabilities

• Quality of Life Form tracking physical, emotional, and social well-being over a week.
• Daily Health Status Form assessing overall health on a 1–10 scale.
• Adverse Event Self-Reporting Form enabling patients to report adverse events and prompt site action.
• Medication Adherence Form assessing adherence, side effect experience, and support received from the study team.
• Mental Health and Mood Assessment Questionnaire tracking cognitive and social functions, depression, and anxiety symptoms.
• Activity Level Form tracking general activity levels pre- and post-study.
• Daily Routine Observation Form assessing engagement with eating, sleeping, and work-related tasks.
• Symptom Observation Form gathering information about participant-experienced symptoms.

eObsROs and eCRFs

• eObsROs enable site staff and clinicians to confidentially gather information related to participants, adverse events, and suspected product or medical equipment conditions.
• eCRFs support AI-powered classification of supplier documents including questionnaires, certificates, and test reports.
• Workflow optimization automates the R&D → QA → Audit progression, reducing back-and-forth between teams.
• Advanced search and retrieval capabilities allow querying across all supplier documentation by questionnaire questions and document categories.

Device Integration and EHR Connectivity

• Vendor-agnostic connectivity supports secure integration with a wide range of patient wearables and home medical devices such as blood pressure cuffs and continuous glucose monitors.
• Passive data capture automatically streams continuous, high-fidelity digital biomarker data.
• FHIR-standard compliant API architecture ensures future-proof device connectivity.
• Secure EHR/EMR data extraction pulls relevant clinical data directly from the patient's existing records, forming the foundation for eSource.
• Automated mapping aligns EHR data fields directly to eCRF/EDC fields, reducing manual transcription and data cleaning effort.

Prebuilt Source Documents and Supplier Qualification

• Modular document library provides access to pre-validated templates including eConsent forms, site-ready documentation, and Informed Consent Forms (ICFs).
• Internal automation capabilities (including DocuGenX) enable rapid customization and document generation.
• Supplier Qualification Automation System automates extraction and validation of supplier data, freeing procurement experts to focus on risk assessment rather than data entry.

Key Platform Features

• Compliant framework providing a single, secure, audit-ready source for all outcome data including ePROs and eObsROs.
• Real-time data capture making data immediately available for review and analysis.
• Intuitive, patient-centric user interfaces optimized for smartphones and tablets.
• Automated reminders and smart notifications to boost participant adherence and compliance with dosing and reporting schedules.
• Multi-lingual support facilitating broader global inclusivity and access.

Key Benefits: Access, Quality, and Efficiency

• Wider reach accessing up to 70% of potential participants who live too far from traditional research centers.
• Reduced patient burden by eliminating unnecessary travel, making participation feasible for individuals with job, family, or health mobility limitations.
• More representative trial data by reaching diverse geographical and demographic groups, supporting regulatory approval and market adoption.
• Real-time data streams that are time-stamped and immediately captured from remote tools, eliminating data lag and transcription errors.
• Proactive monitoring enabling CRAs and sponsors to identify trends, safety issues, and protocol deviations as they occur.
• Built-in 21 CFR Part 11 compliance with automated audit trails across all electronic forms.
• Accelerated trial start-up through prebuilt source documents that reduce protocol review and IRB/EC submission timelines.
• Reduced site burden via EHR integration and automated scheduling, freeing staff from repetitive administrative tasks such as manual SDV and scheduling calls.
• Flexible hybrid design supporting both fully decentralized and hybrid trial models without requiring a platform change.
• Potential for 50% faster trial enrollment, retention rates of 80–85%, up to 50% reduction in on-site monitoring visits, and overall clinical trial cost reductions of 10–25%.

The Decentralized Trials platform supports global studies with multi-lingual capabilities, FHIR-compliant integrations, and 21 CFR Part 11-aligned compliance frameworks, making it suitable for sponsors and CROs operating across diverse regulatory environments. Its hybrid-ready architecture ensures organizations can adapt to evolving protocol needs and regulatory requirements without switching technology platforms.