Sheila brings 30+ years of global QA leadership, auditing sponsors, CROs, systems, and investigator sites against FDA, ICH-GCP, and GxP standards. Having served across CRO, sponsor, and FDA perspectives, she brings a 360-degree view of quality to trial delivery. Sheila has led inspections, CAPAs, and remediation efforts across hundreds of trials and vendors, anchoring Stack’s operating system through rigorous regulatory, validation, and systems-integration oversight.
The Clinical Research
Operating System
The infrastructure that improves study outcomes and control. We unify trial management and patient recruitment into one intelligent OS, giving sponsors total oversight and faster timelines.
- 21 CFR Part 11
- ICH/GCP
- HIPAA
- GDPR Compliant
Tired of CRO holding your data and the inability to do real-time analytics?
Is outsourcing clinical research to a CRO really the only possible solution?
Imagine a world where every promising therapy can reach patients faster – not slowed by fragmented systems, manual workflows, or service models built to bill hours.
Stack is building that future:
The first integrated infrastructure for full-service clinical trial
10x
Faster Workflow Efficiency
20%
Lower Cost Vs. Traditional CROs
Real Time
Data Access & Analytics
SOLUTIONS
A New Paradigm
Stack unifies a compliant clinical operating system with real‑time clinical intelligence, giving biotechs full control of trial execution and data‑driven decision‑making.
Operating System
Stack is an embedded, end-to-end, and regulatory-compliant clinical trial operating system that improves trial outcomes and efficiency by putting biotechs in the driver’s seat – without reliance on an outsourced CRO or the risk of added workflow burden.
Clinical Intelligence
Stack provides immediate, direct access to your clinical data and insights, anywhere and anytime, without turnaround time or cost. Directly query your data.
proven experience across global brands
OPERATING SYSTEM
Restoring Control to Innovators
Biotech innovators shouldn’t lose control of their own science. Stack re-centers control with a fully transparent, unified operating system.
Unified Full-Service Operating System
Enterprise systems of records with SOPs and process maps for compliant data collection and trial execution
Quality and Clinical Analytics Tools
Medical science performance analysis and quality assurance
Significantly Lower Cost
Removing the CRO middleman while improving quality, compliance, and transparency
Experienced Therapeutic Team
Bespoke A team dedicated to your study across therapeutic areas, physically next to you
“Stack provides compliant infrastructure that we need to run global trials, allowing us to regain control of our asset. We no longer need to hire a CRO”
–Chief Development Officer of Public Biotech
CLINICAL INTELLIGENCE
Enabling True Adaptive Design and Bringing Forward Data-Driven Decisions
No more rudimentary analytics, hiring SAS programmers, or spending unnecessary resources and time on data reports to answer individual questions. Stack’s AI co-pilot enables data interrogation in a step-wise manner to make better toxicity and efficacy assessments in real-time.
Immediate Detection of Tox and Efficacy Signals
Analyze any increments of your clinical data anytime – no more rigid SAP plan.
Enhanced Data Quality and Trial Compliance
Reduce protocol deviations and site enrollment imbalances via independent quality checks across sites and vendors.
Informed Decisions from Robust Insights
Incorporate any relevant asset data to discover insights for in-licensing or transaction due diligence
Higher Probability of Success
Better execution and real-time optimization lead to better trial outcomes and faster patient impact.
“Stack fulfills a void in the industry that enables one to do a better job of interrogating data to make safety and efficacy decisions real time”
– COO of a mid-sized Biotech
TEAM
Meet our Leadership Team
Stack leadership brings 80+ years of combined experience from top-tier pharma and CROs, managing over 100 clinical trials across multiple indications – we are building what we would have loved to have as trial operators and sponsors.
Stack embeds the operational discipline, regulatory expectations, and data rigor from our experience of multiple new treatment approvals.
Brian Mooney
PRESIDENT
Brian has built and scaled global CROs and clinical organizations delivering Phase I–IV trials across multiple therapeutic areas, including oncology and metabolic disease. He has led the development and operationalization of enterprise-grade clinical infrastructures including systems of record and processes. With more than four decades in clinical research focused almost exclusively on biotech sponsors, Brian’s focus is to deliver a more reliable, efficient, and data-centric operating model purpose-built for biotech drug development.
Heidi Guthrie
CLINICAL OPERATIONS LEAD
Heidi brings 25 years of industry experience and has led cross-functional teams executing more than 100 trials at the national and global level, from study start-up through CSR delivery. She has overseen systems of record, cross-functional execution, and complex trial logistics. Heidi delivers deep, real-world trial operations expertise to address the execution challenges faced by biotech sponsors.
Earlita Rattei
DATA SYSTEMS LEAD
Earlita is a clinical data management expert with 20+ years of experience designing and managing Phase I–III clinical databases, ensuring data integrity, CDISC compliance, and audit-ready database lock. She has directly supported interim data reviews for DSMBs, endpoint committees, dose escalation decisions, and IND submissions. Her expertise ensures delivery of a data environment trusted by both sponsors and regulators, not just data that passes QC.
Sheila Johnson
Regulatory Compliance and Quality Lead
proven experience across global brands
CONTACT US
Clinical Research Partnering
Ready to transform your development program? Share your details below and our clinical operations team will reach out.
Copyright © 2026 Stack Clinical Research