Clinical Trials Management Framework
Shift from reactive trial management to proactive program control.
Unlock up to 30% faster trial cycles and $1M+ in budget accuracy.
The Mushroom Solutions Clinical Trials Management Framework is a unified, AI-driven command center. By automating operational workflows and converting data into predictive, de-risked decisions, it grants you total, real-time control over global portfolios. These slashes monitor overhead and ensure Day 1 submission readiness, simultaneously eliminating site administrative burden to accelerate payment cycles.
Our Solutions
The Mushroom Solutions’ Clinical Trials Management Framework is a unified operational platform built for the complexities of modern clinical research. By centralizing every essential function like study design, budget & coverage analysis, to adverse event tracking via Agentic AI and Intelligent Automation, we empower your team to focus on science and patients, not spreadsheets.
Manage the entire lifecycle of your trial via a centralized Operating System ensuring unified data, workflow governance, and immediate audit readiness.
- Trial & Site Portfolio Overview: A high-level dashboard providing real-time status, performance metrics, and compliance risk scoring across all active trials and global sites.
- Audit Trail & Validation: Complete, time-stamped, and 21 CFR Part 11 compliant record-keeping for all actions, documents, and data changes within the system.
- Contact and Resource Management: Maintain a single source of truth for all study personnel (sponsor, CRO, site), vendors, and essential contact details.
- Secure Document Exchange: Facilitate the secure, compliant exchange and storage of regulatory and operational documents between the sponsor, CRO, and clinical sites.
- Real-Time Data Capture & Validation: Capture patient data digitally during the visit with automated edit checks and real-time validation. This eliminates transcription errors and reduces queries by up to 80%.
- Automated Participant Recruitment: Leverage digital outreach and automated pre-screening tools to identify and enroll the right participants faster, ensuring diverse cohorts and meeting recruitment milestones ahead of schedule.
- Unified Investigator Portal: Provide site staff with a centralized “Mission Control” for protocols, task automation, and collaboration tools. This reduces site administrative burden and allows coordinators to focus more on patient care.
- Audit-Ready Source Documentation: Automatically generate secure, timestamped, and compliant source documents. This ensures your data is “born digital” and immediately ready for remote monitoring or regulatory inspection without the need for manual scanning.
- Pre-built & Customizable Templates: Utilize a library of standardized source document templates to launch studies faster, or customize them to fit specific therapeutic needs, ensuring seamless data capture from Day 1.
Leverage predictive AI and historical data to optimize your protocol and trial setup, ensuring feasibility, maximizing patient retention, and accelerating the path to launch.
- Protocol Simulation & Optimization: Utilize predictive models to test protocol complexity, forecast site performance, and suggest optimized visit schedules for maximum efficiency before
- Feasibility Assessment Tool: Data-driven evaluation of potential sites based on criteria like patient population, prior performance, and staffing capacity.
- Recruitment Forecasting: Model expected patient enrollment curves and identify potential recruitment shortfalls early in the planning phase.
Streamline coordination between the clinical team and sites, automating workflows and ensuring every milestone is tracked, reported, and achieved on time.
- Automated Site Activation Workflow: Manage and track all steps (e.g., contract execution, IRB/Ethics approval, training) required to bring a site from selection to First Patient In (FPI).
- Clinical Monitoring & Oversight: Centralized management of all monitoring activities (on-site, remote, centralized), including automated trip report generation, review, and sign-off.
- Risk-Based Quality Monitoring (RBQM): AI-driven algorithms automatically prioritize sites and data points based on risk indicators, directing monitors to critical areas and reducing unnecessary travel.
- Task & Action Item Management: Configurable, role-based workflows for assigning, tracking, and completing all corrective and preventative actions (CAPAs) and study-related tasks.
Gain full visibility and control over all financial activities related to the clinical trial, from initial budgeting through final reconciliation and payments.
- Financial Tracking & Reporting: Comprehensive dashboards detailing committed spending, actual expenditures, and remaining budget across the entire trial portfolio.
- Invoice and Payment Tracking: Manage vendor and site invoices, tracking payment status against budget commitments, and ensuring timely financial closure.
- Integration with ERP/Accounting Systems: Seamless data exchange with enterprise financial systems to ensure general ledger accuracy and simplified audit trails.
Ensure budget accuracy and billing compliance with an automated system that correctly prices procedures and differentiates research costs from standard-of-care.
- Protocol-Based Budget Creation: Generate accurate, detailed site budgets automatically from the approved study protocol, ensuring consistency and fair compensation across all sites.
- Coverage Determination Engine: Automatically calculate standard-of-care vs. research-related costs based on local policy and national coverage analysis guidelines (a critical component for compliant billing).
- Sponsor-Site Budget Negotiation Portal: A collaborative, version-controlled environment to manage the budget negotiation process, accelerating contract execution.
- Automated Site Payments: Trigger automated payments to sites and participants based on verified patient visits and completed milestones, drastically reducing payment lag and site burden.
Shift from manual reporting to proactive risk and safety management with automated tracking, alerting, and categorization of all compliance and safety events.
- Adverse Events (AE) Tracking & Reporting: Log, classify, and track all adverse events in real-time. Automated alerts ensure timely reporting to relevant parties (e.g., IRB/EC, Regulatory, Safety Teams).
- Protocol Deviation Management: Standardized workflow for documenting, assessing, and resolving protocol deviations, with automated categorization to identify root causes and recurring risks.
- Compliance Checklists & Reminders: Automated reminders and checklists tied to regional and study-specific regulatory requirements, ensuring nothing is missed.
Move Beyond Reporting. Our AI-Led Intelligence Platform transforms siloed data into predictive foresight, enabling proactive interventions that optimize performance and minimize program risk across your entire portfolio.
- Generative AI-Powered Insights: Utilize Large Language Models (LLMs) to analyze unstructured data (e.g., trip report text, site correspondence) and automatically generate summaries of site risks, performance narratives, and proposed corrective action plans (CAPAs).
- Predictive Risk Modeling: Every site and activity is assigned a dynamic risk score based on Machine Learning algorithms that analyze real-time inputs (e.g., protocol deviations, data query volume, overdue tasks), enabling targeted and efficient resource deployment.
- Real-Time Operational Intelligence (ROA): Intuitive, customizable dashboards deliver a holistic and immediate view of trial health, tracking key operational metrics and identifying bottlenecks before they impact timelines.
- Multi-Source Data Fusion for 360° Health: Seamlessly integrate operational data (CTMS) with clinical data (EDC/eSource) and safety data into a unified data lake, providing a comprehensive, single-pane-of-glass view of trial performance.
- Enrollment and Budget Forecasting: AI models predict future enrollment curves and budget burn rates with high accuracy, allowing sponsors to make timely, data-backed decisions on resource allocation and budget adjustments.
Key Benefits
Our Clinical Trials Management Framework is not just a solution—it’s an investment in predictable trial execution and operational excellence.
- Accelerate trial start-up
- Eliminate manual data entry and fragmentation
- 21 CFR Part 11 compliant audit readiness
- Simplify collaboration
- Reduce monitoring costs by up to 50%
- Accelerate database lock by 3-4 weeks
- Guarantee 100% data integrity (ALCOA+)
- Maximize site capacity and performance
- Drive targeted recruitment and diversity
- Immediate safety signal detection
- Reduce costly amendments
- Optimize recruitment strategy
- Maximize retention
- Achieve billing compliance
- Accelerate site payments
- Improve budget forecasting
- Elevate data integrity
- Proactive intervention to safety signals
- Streamline reporting of Serious Adverse Events (SAEs)
- Predictive risk identification
- Accelerated decision-making
- Strategic foresight
20% reduction in study startup time
5-7 studies per coordinator
99.9% traceability for audit readiness (21 CFR Part 11 compliant)
100% compliant invoicing
Harness the power of the Clinical Trials Management Framework unifying the critical pillars of trial execution—Study Management, Financial Intelligence, and Predictive Oversight