70% of potential clinical trial participants live more than two hours away from a research site.
Mushroom Solutions’ Decentralized Clinical Trial (DCT) platform revolutionizes how you conduct research. By bringing the trial to the participant—leveraging integrated eCOA, ePRO, Virtual Visits, and Device Integration—we eliminate geographic constraints, dramatically accelerating your timeline and enriching your data.
Our Solutions
Our DCT platform is an end-to-end solution designed to maximize data quality, compliance, and operational agility. It ensures a single source of truth across all remote and site activities.
- Compliant Framework: Provides a single, secure, audit-ready source for all outcome data (including ePROs and eObsROs).
- Real-Time Data Capture: Allows data to be captured and immediately available for review and analysis.
- Intuitive Design: User interfaces are optimized for patient-centricity on any device (smartphone, tablet).
- Automated Reminders: Smart notifications boost participant adherence and compliance with the dosing/reporting schedule.
- Multi-Lingual Support: Facilitates broader global inclusivity and access.
- Global Assessment Form: Assess the overall health status, symptoms, and functionalities of a participant to gauze overall treatment response and wellbeing.
- Behavioral Observation Questionnaire Form: Track and rate specific behavioral indicators of participants.
- Medication Compliance Form: Track and assess participant compliance towards dosing schedule.
- Clinician-Administered Quality of Life (QoL) Questionnaire: Assess physical health, psychological well-being, social functioning to rate the overall QoL of a participant.
- Adverse Event Observation Form: Track relationship of study drug or procedure to any reported adverse event.
- 6-minute Walk Test (6MWT) Questionnaire: Assess walking ability of a participant and gather feedback on pre and post walk conditions
- Cognitive Performance Form: Test cognitive performance of patients related to concentration, memory, and executive functioning.
- Functional Mobility Assessment Form: Track performance of a participant in regard to basic mobility activities.
- Physical Activity Tracking Questionnaire: Track physical activities undertaken by a participant and frequency and level of comfort while undertaking them.
- Timed Up and Go (TUG) Test Assessment Form: Qualitative assessment of participant performance like gait, turn, sitting down under timed constraints.
- Hand Grip Strength Assessment Form: Qualitative assessment of participant grip strength and inspection of underlying conditions.
- Quality of Life Form (ePRO): Track physical, emotional, social well-being of participants over a week.
- Daily Health Status Form: Assess overall health rating of a person over a scale of 1-10.
- Adverse Event Self-Reporting Form: Enable patients to report adverse event and initiate prompt action from Site.
- Medication Adherence Form: Assess participants’ adherence to medication, side effect experience, and support and resources received from the study team.
- Mental Health and Mood Assessment Questionnaire: Assess mood and track cognitive and social functions, symptoms of depression, anxiety.
- Activity Level Form: Track pre and post study general activity level of participants.
- Daily Routine Observation Form: Assess engagement level of a participant with regards to daily routine like eating, sleeping, work-related tasks.
- Symptom Observation Form: Gather information about the symptoms experienced by the participant.
Gather information for Site staff and clinicians related to participant, adverse events, and suspected product and medical equipment condition confidentially.
- Supplier Document Management: AI-powered classification of supplier documents (questionnaires, certificates, test reports).
- Workflow Optimization: Automate R&D → QA → Audit progression.
- Search & Retrieval: Advanced search by questionnaire questions and document categories across all supplier documentation.
- Vendor-Agnostic Connectivity: Supports secure connections to a wide range of patient wearables and home medical devices (e.g., blood pressure cuffs, continuous glucose monitors).
- Passive Data Capture: Automatically streams continuous, high-fidelity data (Digital Biomarkers).
- FHIR Standard Compliant: Utilizes a robust API architecture for future-proof connectivity.
- Secure Data Extraction: Facilitates the secure pull of relevant clinical data directly from the patient’s existing EHR/EMR (the foundation for eSource).
- Automated Mapping: Maps EHR data fields directly to your eCRF/EDC fields.
- Modular Document Library: Access a repository of pre-validated templates (e.g., eConsent forms, site-ready documentation, ICFs).
- Automation-Enabled: Leverages internal automation capabilities (like DocuGenX) for rapid customization and generation.
Key Benefits
Our Decentralized Clinical Trial solution delivers more than just digital tools—it provides a strategic advantage by transforming three core pillars of research: Access, Quality, and Efficiency.
DCT technology removes the rigid geographic and logistical barriers of traditional sites, opening the trial to previously underserved populations.
- Wider Reach: Access up to 70% of potential participants who live too far from research centers.
- Reduced Patient Burden: Eliminating unnecessary travel and appointments increases convenience, making participation feasible for individuals with job, family, or health mobility limitations.
- Representative Data: By reaching diverse geographical and demographic groups, your trial data becomes more representative of the real-world patient population, crucial for regulatory approval and market adoption.
By capturing data directly from the source (devices and participants), we minimize manual steps and human errors, leading to higher data fidelity.
- Real-Time Data Streams: Data is time-stamped and streamed immediately from remote tools (ePROs, devices), eliminating data lag and transcription errors associated with paper.
- Proactive Monitoring: Real-time data access allows CRAs and Sponsors to identify trends, safety issues, and protocol deviations as they happen, enabling proactive interventions.
- Regulatory Confidence: Automated audit trails and built-in 21 CFR Part 11 compliance across all electronic forms ensure the integrity and reliability of your final submission data.
- Consistency and Auditability: Real-time data capture and screening with automated alerts for safety events ensures freshness and purity of data across global studies.
- Data Integrity and Accuracy: Digital forms ensure data integrity and accuracy in specialized trials (e.g., pediatric or cognitively impaired studies) where self-reporting is not possible.
- Dramatically reduces transcription errors and simplifies data cleaning by creating a direct data path from the source.
- Collects rich, continuous data without adding burden to the participant or site staff.
The platform is designed to streamline processes, shifting the workload from administrative tasks to high-value clinical activities.
- Accelerated Start-Up: Leveraging our Prebuilt Source Documents drastically reduces the time needed for protocol review and IRB/EC submission.
- Reduced Site Burden: Features like EHR Integration and automated scheduling free up site staff from repetitive administrative duties (like manual SDV and scheduling calls), allowing them to focus on patient care and clinical judgment.
- Future-Proof Hybrid Design: Seamlessly supports both fully decentralized and hybrid models, offering the flexibility to pivot based on protocol needs or global regulatory changes without switching technology platforms.
- Simplifies daily reporting from home, minimizing burden and improving engagement.
- Drastically reduces the workload for Source Data Verification (SDV) by automating data transfer, allowing CRAs to focus on quality review.
- Accelerates IRB/EC submissions and trial start-up by providing "ready-to-deploy" regulatory-aligned content from Day 1.
DCT offers 50% faster trial enrollment than traditional studies.
Trials utilizing decentralized components report retention rates as high as 80-85%.
Use of remote monitoring and eSource (via EHR %. Integration) can reduce the number of on-site monitoring visits by up to 50
Fully decentralized trials show the potential for overall clinical trial cost reduction between 10% and 25%
End Enrollment Crisis. Start Your Decentralized Trial Today.