Catalyst Oncology accelerates innovation by aligning strategic insight, deep expertise, and flawless execution. With global reach, we fast-track development timelines through a seamlessly integrated approach, empowering biotechs to deliver life-changing therapies to patients worldwide—faster, smarter, and with purpose.
Critical considerations for global trial success
Executing a trial across regions requires more than operational readiness—it demands strategic planning across regulatory, cultural, and logistical dimensions. The following considerations help ensure precision and speed throughout trial design and execution.
Smart Trial Designs
Adaptive protocols, PK/PD strategies aligned with Project Optimus and expansion cohorts.
IP & Sample Logistics
Cold chain management, sample integrity, and contingency planning for global supply.
Global Execution Strategy
Multiregional planning with regulatory insight, infrastructure readiness, and cultural fluency.
Risk-Based Monitoring & Safety Oversight
Centralized analytics and proactive reviews to mitigate risk and protect patient safety.
Study Startup & KOL Engagement
Targeted site selection and early KOL input to drive recruitment and visibility.
Communication & Vendor Oversight
Transparent leadership and integrated dashboards for team alignment.
Data Driven Approach
Real-time data to support agile decisions across dynamic study arms.
Data Privacy & Regulatory Compliance
Governance aligned with GDPR, HIPAA, and global standards.
Global Footprint to Support Early- to Late-phase Trials
Catalyst Oncology supports global trials from FIH to registrational Phase III with 1,000+ staff across North America, Europe, and Asia-Pacific. Our global infrastructure enables seamless execution of oncology studies at every stage of development.
Exclusively biotech-focused
Built to work exclusively with biotechs, our flexible processes and approach allow us to listen first, align goals, and execute with an eye toward rapid shifts when a protocol is amended or Breakthrough designation moves a product straight from Phase I to registration.
Seasoned oncology experts
With an average of 9+ years of oncology experience for key roles (PM, CTL, DM, Bios, Clinical Science), our oncology specialty guarantees you a seasoned team across all functions.
A transparent people-first culture with industry-leading retention
We are responsive and attentive to the needs of both our customers and staff. Our industry-leading employee and project team retention guarantees program continuity, increased efficiency, and happy investigative sites.
Additional differentiators
Catalyst Oncology offers a flexible data-driven approach with an experienced network of sites across a global footprint.
Active next-gen oncology experience
Working both locally and globally across Phases I through III in a range of solid tumor and hematologic indications, we understand the nuances of complex study designs, novel endpoints, and cutting-edge technologies.
