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.
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.
The first integrated infrastructure for full-service clinical trial
Faster Workflow Efficiency
Improved Trial Outcomes
Data Access & Analytics
Stack unifies a compliant clinical operating system with real‑time clinical intelligence, giving biotechs full control of trial execution and data‑driven decision‑making.
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.
Stack provides immediate, direct access to your clinical data and insights, anywhere and anytime, without turnaround time or cost. Directly query your data.
Biotech innovators shouldn’t lose control of their own science. Stack re-centers control with a fully transparent, unified operating system.
Enterprise systems of records with SOPs and process maps for compliant data collection and trial execution
Medical science performance analysis and quality assurance
Removing the CRO middleman while improving quality, compliance, and transparency
Bespoke A team dedicated to your study across therapeutic areas, physically next to you
Analyze any increments of your clinical data anytime – no more rigid SAP plan.
Reduce protocol deviations and site enrollment imbalances via independent quality checks across sites and vendors.
Incorporate any relevant asset data to discover insights for in-licensing or transaction due diligence
Better execution and real-time optimization lead to better trial outcomes and faster patient impact.
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.
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 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.
Clinical research leader with 17+ years of experience managing Phase I–II clinical trials in metabolic diseases (NASH/NAFLD, diabetes, obesity). Proven track record of leading cross-functional teams, managing vendors and CRAs, and delivering studies on time, within budget, and in compliance with FDA and ICH-GCP regulations.
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 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 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.
Former Amgen and Abbott quality and audit leader with over 20 years experience in clinical operations and compliance. Deep knowledge and experience with major Pharmaceutical, Biotechnology, Medical Devices and CRO organizations.
Molestie odio inceptos adipiscing dui dictum. Sodales aptent hac tristique integer nullam in vestibulum. Hac feugiat placerat laoreet fames pharetra pede imperdiet sodales in.
Ready to transform your development program? Share your details below and our clinical operations team will reach out.
(555) 987-6543
hello@stackclinical.com
