Bringing Life-SavingTherapies to Market
Unified Intelligence - Partner with industry-leading clinical trial experts to navigate critical pathways and accelerate your biotech and medical device innovations from Phase I to Commercialization, Registries and publications.
Trials Executed
Across Therapeutic Areas
Safety Reporting Timeliness
On-Time Submissions
Enrollment Performance
Meeting Target Timelines
Average Time to Database Lock
30 Days
TopLine Results
within 10 Days of Lock
UNIFIED INTELLIGENCE
Where planning meets precision—delivering compliant,high-impact clinical outcomesevery single time.
Our approach integrates Strategy and Planning with operational excellence to ensure every trial is built for success from the start.
STARTING WITH THEEND IN MIND.
Every successful trial begins with a clear understanding of your goals. We align our strategy to deliver on your vision—from regulatory approval to commercial success.
Client-Centric Approach
Your vision drives our strategy and execution
Proactive Risk Management
Identifying and mitigating challenges before they impact timelines
Clear Accountability
Defined milestones and deliverables at every stage
Optimized Resource Allocation
The right expertise deployed at the right time
Every Subject Counts.
Every single Subject needs to be Analysis Viable.
Retention is a Strategy
We view subject retention as a core strategic pillar, not just a performance metric.
Beyond Checklists
Our oversight goes deeper than protocol checklists and static data listings to ensure full context.
Proactive Support
We provide early and proactive support to ensure subject retention and compliance from day one.
Every Detail Matters
We understand that even small deviations can affect outcomes, so we manage every detail with precision.
How We Think About Data.
Ultimately, data must help us make critical decisions across the entire study landscape.
End-to-End ClinicalTrial Solutions
From preclinical strategy to post-market surveillance, we provide the expertise and infrastructure to accelerate your therapeutic development journey.
Phase I-IV & Post-Market
Comprehensive trial design, execution, and management across all phases of clinical development.
- First-in-Human Studies
- Efficacy Trials
- Phase IV Studies
- Registries
- Retrospective Studies
Regulatory Affairs
Expert guidance through FDA, EMA, and global regulatory pathways for faster approvals.
- IND/IMPD Submissions
- Protocol Review
- Regulatory Strategy
- Inspection Readiness
Biostatistics
Advanced statistical analysis and design ensuring robust scientific evidence for regulatory submissions.
- Statistical Planning
- Sample Size Calculation
- Interim Analysis
- Statistical Programming
Data Management
Robust data management systems ensuring data integrity and regulatory compliance.
- Clinical Data Management
- CDISC Standards
- Database Design
- Data Quality Control
Data Analytics
Derive actionable insights from complex datasets with our advanced analytics engine.
- Real-Time Dashboards
- Predictive Analytics
- Enrollment Forecasting
- Data Visualization
Global Site Management
Worldwide network of research sites with experienced investigators, patient recruitment, and seamless multinational trial execution.
- Site Selection & Activation
- Patient Recruitment
- Site Monitoring
- Multi-Regional Trials
- Local Partnerships
RTSM Strategy & Management
Comprehensive randomization and trial supply management ensuring optimal drug supply and study integrity.
- Randomization Strategy
- Randomization Execution
- Supply Chain Strategy/Management
- Inventory Surveillance
- Central Depot Oversight
- Global Supply Management
- Platform Configuration
PV Management
Comprehensive pharmacovigilance solutions ensuring safety compliance and risk management.
- AE/SAE Processing & MedDRA Coding
- Safety Management Planning
- SUSAR Reporting
- Aggregate Safety Reporting
- 24x7 Medical Monitoring
Quality Assurance
Rigorous quality systems ensuring GCP compliance and regulatory standards.
- GCP Compliance
- Quality Audits
- Risk Management
- CAPA Systems
Ready to Accelerate Your Clinical Trial Program?
Schedule a consultation with our experts to discuss your specific needs and timeline.
Unify PlatformIntegrated Excellence
Our comprehensive technology platform unifies every aspect of clinical trial management in a single, integrated ecosystem designed for efficiency and compliance.
Unified Intelligence
Experience the power of complete integration where every module communicates seamlessly, providing real-time insights and eliminating data silos.
Electronic Data Capture
Streamlined data collection with real-time validation and monitoring capabilities.
Randomization & Trial Supply Management
Automated randomization and supply chain management for optimal trial efficiency.
Laboratory Management
Integrated lab data management with automated result processing.
Advanced Reporting
Real-time analytics and customizable reports for stakeholder visibility.
Safety Management
Automated adverse event reporting and safety signal detection.
Data Analytics
Derive actionable insights from complex datasets with our advanced analytics engine.
Experience the Unify Platform
See how our integrated technology platform can streamline your clinical trials and accelerate your path to market.
TherapeuticConsiderations
Deep expertise across complex therapeutic areas means we understand the nuances, clinical trial strategy, and operational challenges unique to your indication.
Various Areas of Therapeutic Experience
Oncology
Precision Medicine for Cancer Breakthroughs
Cancer trials demand unprecedented precision and patient-centric approaches. We understand the complexities of tumor heterogeneity, biomarker-driven patient selection, and adaptive trial designs that accelerate your path from discovery to approval. The oncology landscape is evolving rapidly with immunotherapy, CAR-T therapies, and targeted treatments requiring sophisticated trial methodologies. Our team has navigated a huge number of oncology trials across solid tumors, hematological malignancies, and rare cancers—from first-in-human dose escalation studies to pivotal Phase III registrational trials. We specialize in basket and umbrella trial designs that maximize efficiency while maintaining scientific rigor, and our deep relationships with leading cancer centers ensure access to the patient populations critical for your success.
Key Therapeutic Considerations
ARDS & Respiratory
Critical Care Innovation
Acute Respiratory Distress Syndrome trials require rapid deployment, specialized ICU site networks, and real-time safety monitoring. Our experience in critical care ensures your trial navigates the unique challenges of severely ill patient populations and emergency protocols. ARDS patients are among the most critically ill, requiring immediate intervention and intensive monitoring. We've built a network of tertiary care centers with dedicated ICU research teams capable of enrolling patients in crisis situations while maintaining ethical standards and protocol compliance. Our 24/7 medical monitoring services ensure immediate response to adverse events, and our expertise in ventilator management protocols, ECMO considerations, and multi-organ failure scenarios means your safety data will withstand the most rigorous regulatory scrutiny. We understand the urgency of bringing life-saving respiratory therapies to market and have the operational excellence to match that urgency.
Key Therapeutic Considerations
CNS & Neuroscience
Navigating the Most Complex Trials
Central Nervous System disorders present unique regulatory and operational challenges—from placebo response variability to long-term cognitive assessments. We bring specialized expertise in neuroscience trial design, validated assessment tools, and patient retention strategies critical for CNS success. Neuroscience trials consistently face the highest failure rates in drug development, often due to inadequate trial design, poor patient selection, or inability to demonstrate clinically meaningful endpoints. We've successfully navigated trials in Alzheimer's disease, Parkinson's, depression, schizophrenia, and rare neurological disorders. Our proprietary patient retention programs achieve industry-leading completion rates, and our expertise in FDA's recent guidance on CNS trial design ensures your program aligns with current regulatory thinking from day one.
Key Therapeutic Considerations
Don't See Your Therapeutic Area?
With experience across 50+ therapeutic areas, we bring the expertise needed to navigate your unique regulatory and operational challenges.
UNIFIEDDELIVERY
Strategic Planning
Clinical Management
Safety Management
PV/Safety Management
Biometrics
SERVICES DETAILED BREAKDOWN
Deep dives into our comprehensive service offerings and strategic approach
STARTING WITH THE END IN MIND.
Every successful trial begins with a clear understanding of your goals. We align our strategy to deliver on your vision—from regulatory approval to commercial success.
Client-Centric Approach
Your vision drives our strategy and execution
Proactive Risk Management
Identifying and mitigating challenges before they impact timelines
Clear Accountability
Defined milestones and deliverables at every stage
Optimized Resource Allocation
The right expertise deployed at the right time
STRATEGY AND PLANNING
Delivering on the needs of Starting with the end in Mind.
Goal Alignment
Understand sponsor vision, endpoints, timelines.
Deep dive into your objectives to ensure every aspect of the trial aligns with your ultimate goals and regulatory pathway.
Developing the Strategy
Creating the strategy that will deliver on the client vision.
Crafting comprehensive trial strategies that balance scientific rigor, regulatory requirements, and operational efficiency.
Feasibility & Risk Planning
Identify potential challenges early.
Proactive risk identification and mitigation strategies to ensure trial success from the start.
Operational Roadmap
Clear milestones, deliverables, and accountability.
Detailed project plans with defined timelines, responsibilities, and success metrics.
Resource Optimization
The right expertise at the right time.
Strategic allocation of specialized resources to maximize efficiency and trial outcomes.
"Fuel delivers seamless RTSM and global supply management—covering randomization, drug assignment, inventory tracking, expiry management, and global depot coordination.
From forecasting and resupply triggers to temperature excursion handling and shipment oversight, we ensure every site has the right product, at the right time, in full compliance with regulatory and protocol requirements."
RTSM /SUPPLY CHAINMANAGEMENT
OVERVIEW
RTSM /SUPPLY CHAINMANAGEMENT
Randomization Strategy
Randomization Execution
Supply Chain Strategy / Management
Inventory Surveillance
Central Depot Oversight
Global Supply Management
RTSM Planning & Strategy
Randomization / Cohort Management
Supply Chain Management
RTSM /SUPPLY CHAINMANAGEMENT
Program-Wide Inventory
- Investigational Product and Ancillary Supplies Management
- Inventory pooling and forecasting
Study / Depot Inventory
- Depot Contracting, Management & Shipping
- Depot Threshold Monitoring
- Lot / Batch Release & Expiry Management
- Final Disposition / Inventory Returns
Site Inventory
- Automated Requests (Site-specific Thresholds / Upcoming Visits) with manual overrides
- Shipment Reminders to reduce stale data
- Quarantine Management
- Site-to-Site Transfers
Accountability
- Dispensing Activities (Site and Subject-Level)
- Kit / vial-level vs. tablet / volume-level accountability
- Single and multi-use devices
"Fuel's biostatistics team delivers end-to-end statistical expertise—from early-phase planning, protocol development, and sample size derivation to SAP design, statistical programming, and comprehensive TLF development.
We provide randomization schedules, CDISC-compliant outputs, and integrated support for medical writing—ensuring every analysis is accurate, submission-ready, and regulatory-compliant."
BIOSTATS
OVERVIEW
BIOSTATSSERVICES
Statistical Consulting
Planning from all phases of development; SAP and TLF design and development
Protocol development
Sample size derivation
Statistical programming
TLF, SDTM Programming, Safety Tables, DSMB Tables
Ongoing Study Support
PK/PD modeling and simulation; Randomization Schedule
Review of Data Management Documents
Regulatory data standards (CDISC) compliance
Support Medical Writing
TFLDEVELOPMENTPROCESS
BIOSTATS
Study Goes Live
Finalized Protocol
Statistical Analysis Plan
Mock Shells (TFLs)
Annotated CRF
Finalized eCRF
Real-Time Data Listings
Database Lock
Raw Data Transfers
Ongoing SDTM configuration
Ongoing ADaM configuration
Derived TFL configuration
Real-Time Clinical Operations
Real-Time DM Operations (during Study)
Final
Final Raw Data Transfer
Complete SDTM
Complete ADaM
TFL Output
Pinnacle 21
Finalization of supporting documentation
------------------- Study Operational Period -------------------
"At Fuel, we treat data as the backbone of every trial—managing it with precision, and uncompromising quality.
We work as an extension of our Clients to deliver clean, accurate, and compliant results—ready for analysis and submission."
DATAMANAGEMENT /ANALYTICS
OVERVIEW
DATAMANAGEMENT
Personalized Leadership and Support
Outcome-Focused Study Planning
Collaborative, Hand's-On Approach
Optimized Design and Ongoing Oversight
End-to-End Data Integrity
Data Management Structure / Operations
360° Critical Data Review / Analytics
Integrated Monitoring Collaboration
eCRF Design & Build
Data Cleaning and Review
External data handling and Reconciliation
Link into Safety Reconciliation
STARTING WITH THE END IN MIND.
Successful studies begin with submission-ready data in mind; designed to meet regulatory needs.
Data is structured from the start to ensure usability, traceability, and alignment with final deliverables
CDASH standards guide our design, enabling seamless mapping
Built-in consistency reduces rework and accelerates delivery timelines
Early alignment around final outputs avoids late-stage surprises
Your data iseverything.
We manage it with the urgency, discipline, and care it demands
Strategic planning to maximize data value
Proactive monitoring to protect retention and compliance
Engaging Collaboration with CRAs and Teams
End-to-end focus to accuracy and timelines
RETENTIONIN PRACTICE
1. Early Detection
- Monitor for critical data issues, missed visits, gaps in communication, or delayed entry
- Recognize site-level patterns that may signal subject risk
2. Actionable Recommendations
- Propose solutions like follow-up calls, unscheduled visits, retraining, or site reminders
3. Site/CRA Collaboration
- Work with CRAs to address issues before they escalate
- Ensure teams are aligned on next steps to support continuity
4. Preventing Subject Loss
- Anticipate risks before they impact retention
360° DATA/ MONITORINGREVIEW
Visit Timing and Scheduling
- Monitor both completed and upcoming visits
- Identify risks before deviations occur
Lab Results & Follow-Up
- Detect out-of-range or unusual values
- Recommend follow-up when clinically appropriate
Subject Retention
- Track subtle indicators of disengagement
- Coordinate with CRAs to support site outreach
Data Patterns
- Evaluate data timing, completeness and consistency
- Flag trends early to prevent downstream issues
UNIFIEDMONITORING /DATA REVIEW
Aligned with CRA schedules to clean data in real time
Aligned with CRA schedules to clean data in real time
Queries clarified during IMVs to reduce rework
Data cleaned in sync with monitoring visits
Site frustration minimized with timely support
Issues escalated collaboratively, not in silos
Monitoring becomes efficient, not just reactive
"Fuel's data analytics turns trial data into strategic intelligence—combining reporting design, dashboards, interactive patient profiles, and trend analysis with 360° data review strategies.
From clean patient tracking to risk-based monitoring triggers, KPI oversight, and safety trend evaluation, we deliver the insights that drive decisions and strengthen submissions."
DATAANALYTICS
OVERVIEW
DATAANALYTICSUNIFIED
Data Analytics Specialists
Data Warehouse
Data Analytics Platform
Data Analytics Specialists
Talented group of Analytics professionals who can execute your analytical needs
Data Warehouse
Warehouse all of your historical and current studies in a normalized and analyzable fashion
Data Analytics Platform
Dynamic data reporting of various types / Unlimited Possibilities
Strategy
- Reporting Design
- Dashboards
- Interactive Patient Profile
Data Trends
- Risk-Based Monitoring Triggers
- Clean Patient Tracking
- 360° Data Review Strategy
- 360° Data Review Execution
- Quality / KPI Monitoring
Safety Trends
- Primary End-Point Analysis
- CEC / DSMB Reporting
- Trends Analysis across Portfolio
"Patient safety is paramount. Our pharmacovigilance team provides 24/7 medical monitoring, rapid adverse event processing, and proactive risk management to protect trial participants and ensure regulatory compliance."
SAFETY &PV MANAGEMENT
OVERVIEW
ComprehensiveSafety Management
Proactive Safety Oversight, Not Reactive Processing
Our pharmacovigilance philosophy goes beyond checkbox compliance. We deliver proactive, data-driven oversight—continuously monitoring for potential risks, implementing early mitigation strategies, and maintaining transparent communication with investigators and regulatory authorities to ensure participant protection remains the highest priority throughout every phase of your trial.
With a multidisciplinary team of qualified physicians, Safety specialists, and MedDRA-certified medical coders, we provide comprehensive safety surveillance from first dose through post-marketing surveillance. Our experience spans diverse therapeutic areas, from complex oncology's cardiovascular, neurological, and rare disease trials, ensuring every study benefits from vigilant, intelligent, and ethical safety leadership.
Rapid Response Commitment
Our 24/7 medical monitoring team ensures that serious adverse events receive immediate physician review, with expedited reporting to regulatory authorities within required timelines—typically within 24 hours for fatal/life-threatening events.
Our Safety Commitment
Immediate Medical Review
All SAEs reviewed by qualified physicians within 24 hours
Proactive Signal Detection
Continuous monitoring for emerging safety patterns
Regulatory Excellence
Zero regulatory findings in safety inspections
Global Compliance
Adherence to FDA, EMA, and local authority requirements
Comprehensive Pharmacovigilance Services
Safety Management Planning
Proactive safety strategy development and risk management tailored to your therapeutic area—supporting both drug and device programs from planning through ongoing monitoring and lifecycle management.
Comprehensive Adverse Event Management and Medical Coding
We provide end-to-end adverse event management—from case capture and processing to medical coding using the latest standardized terminologies—ensuring precise safety signal detection and full regulatory compliance. Our integrated approach delivers accurate, transparent, and efficient safety monitoring across all clinical trial phases and throughout the product lifecycle for both drugs and medical devices.
Expedited Safety Reporting
We ensure timely and compliant reporting of serious adverse events and other reportable safety incidents to regulatory authorities, ethics committees, and investigators in accordance with global pharmacovigilance and medical device vigilance regulations. Our streamlined processes support accurate case assessment, documentation, and submission, enabling efficient communication, full regulatory compliance, and transparent safety oversight across all clinical trial and post-market phases.
Aggregate Safety Reporting
We prepare comprehensive periodic safety reports (e.g., DSURs, Annual Progress Reports) featuring thorough benefit–risk evaluations and trend analyses. Our proactive approach ensures regulatory compliance, data accuracy, and meaningful safety insights across all phases of product development and post-market monitoring for both drugs and medical devices.
24/7 Medical Monitoring
Round-the-clock medical review and safety oversight by qualified physicians, ensuring immediate response to safety signals and critical events across all time zones.
Safety Database Management
Validated safety database systems with real-time case processing, duplicate detection, and integrated regulatory reporting capabilities.
Safety Performance Metrics
Regulatory Compliance & Standards
Our pharmacovigilance systems and processes are designed to meet or exceed all global regulatory requirements. We maintain current knowledge of evolving safety regulations and implement best practices across all therapeutic areas and geographies.
"We don't just run a trial—we are a direct partner in its success.
Backed by decades of experience, proven strategies, and rigorous oversight, Fuel Clinical Operations works as an extension of your team—ensuring every detail is managed, every milestone is met, and every trial is inspection-ready."
CLINICALOPERATIONS
OVERVIEW
CLINICALOPERATIONS
Service Highlights
Site Management & Monitoring
- Site Selection: Identify high-performing sites with proven enrollment success
- Relationship Building: Continuous engagement for site motivation and retention
- Performance Oversight: Track KPIs and resolve issues proactively
- Risk-Based Monitoring: Focus resources where they matter most
- Data Integrity: Ensure accurate, complete, and verifiable data
Regulatory and Site Submissions
- Regulatory Support: Timely and compliant packages for ethics committees and health authorities
- Inspection Readiness: Ensure documents, processes, and teams meet audit standards
- Site Submissions: Centralized coordination to reduce delays
- Documentation Control: Accurate, consistent, and audit-ready
Vendor Management
- Alignment with Trial Goals: Ensure vendors share operational objectives
- Quality Management: Continuous performance monitoring and corrective actions
- Cost Control: Prevent scope creep with clear deliverables and budgets
- Problem Resolution: Rapid intervention to avoid delays or quality issues
Enrollment Management & Site Engagement
- Enrollment Management: Forecasting, tracking, and rapid intervention plans
- Barrier Identification: Address site-specific challenges early
- Subject Recruitment: Targeted outreach and pre-screening tools
- Patient-Centric Approach: Understand motivations and reduce barriers
- Retention Strategies: Minimize dropouts through clear communication
TMF Management
- Comprehensive TMF Oversight: Ensure all essential documents are present, complete, and inspection-ready
- Version Control: Maintain accurate, current versions of all trial documents
- Structured Filing: Logical, standardized indexing for rapid retrieval
- ICH-GCP Alignment: Full compliance with global regulatory standards
- Inspection Preparedness: TMF always maintained in an audit-ready state
Expertise That DrivesMedical Breakthroughs
Our team of regulatory veterans, clinical experts, and biostatisticians combines decades of experience with cutting-edge methodologies to deliver exceptional results.
A Team Built from Decades of Experience
FUEL CLINICAL is built from professionals with 80 years of senior Leadership experience and over 25 years of combined expertise running clinical trials. Our team includes industry veterans who bring unparalleled depth to every clinical program.
Today, we're trusted by leading biotech companies, academic institutions, and medical device companies to navigate the complex landscape to execute world-class clinical trials.
Our Mission
To accelerate your biotech and medical device innovations through world-class clinical trial management and biometrics expertise.
WHY WORK WITH FUEL?
We care deeplyabout your clinical research.
You can contract with someone.You can pay someone.But you cannot make someone care about your study.
Passion Over Process
At FUEL, we don't just execute trials—we invest ourselves in your success. Every data point, every patient enrolled, every milestone achieved matters to us because we understand what's at stake: bringing life-changing therapies to patients who desperately need them.
Your Vision, Our Mission
When you share your vision with us, it becomes our mission. We don't see ourselves as vendors—we're partners committed to your success. Your regulatory approval is our victory. Your setbacks keep us up at night. Your breakthrough moments are why we do this work.
Relentless Attention to Detail
Care manifests in the details. It's the 11 PM email checking on a concerning safety signal. It's the proactive call before a problem becomes critical. It's the sleepless nights before your FDA submission because we're triple-checking every calculation, every narrative, every document.
Invested in Your Success
We celebrate your wins as our own and take responsibility for challenges. This isn't just business— it's personal. Every trial represents hope for patients, dreams of innovators, and the potential to change lives. That's why we care, and why it makes all the difference.
"The difference between good and extraordinary isn't just about expertise—it's caring deeply about the outcome too."
Meet Our Leadership Team
Andrew Schachter
Founder & CEO
Clinical Development & Corporate Strategy
Visionary leader focused on strategic planning, executional excellence, and delivering outcomes for clinical research organizations.
View Full Bio
Erika Passi
Global Head, Biometrics
Biostatistics & Data Management
Expert in biometrics, leading data-driven strategies to ensure trial integrity and success.
Samia Malik
Director, RTSM
Randomization & Trial Supply Management
Expert in RTSM strategy and global supply chain management, ensuring seamless trial execution across all phases.
Praveen Panga
Director, Pharmacovigilance
Drug Safety & Pharmacovigilance Operations
Over 14 years of experience in drug safety, pharmacovigilance operations, and medical coding across global clinical research. Leads the pharmacovigilance team, ensuring excellence in safety data management, regulatory compliance, and operational performance.
Kevin Mestanza
Senior Director, IT/Infrastructure
Technology & Infrastructure Leadership
Leading technology infrastructure and innovation to power seamless clinical trial operations.
Lovjeet Bola
Head of Finance
Financial Strategy & Operations
Leading financial planning and analysis to support strategic growth and operational excellence.
From emerging biotech/medicaldevice companies to established giants,our clients consistently achieveregulatory success with accelerated timelines.
Trusted by IndustryLeaders Worldwide
From emerging biotech companies to established pharmaceutical giants, our clients consistently achieve regulatory success with accelerated timelines.
Results That Speak for Themselves
Let's Accelerate YourClinical Success
Ready to bring your therapy to market faster? Schedule a consultation with our experts to discuss your specific needs and timeline.
Schedule Your Consultation
Interested in joining our team?
Explore Career OpportunitiesGeneral Inquiries
general@fuelclinical.com
General inquiries
Get in Touch for Partnerships
relationships@fuelclinical.com
Get in touch for help on your next study or program to learn how Fuel can help you achieve your goals.
Headquarters
Toronto
Global operations center
Our Partnership Process
Initial Consultation
Schedule a 30-minute strategy call with our Fuel experts
Proposal Development
Receive a customized proposal within 48 hours
Partnership Launch
Begin your accelerated path to market
Visit Our Headquarters
Toronto, Canada - Global Operations Center
