Site Capabilities Overview
Pan American Center for Oncology Trials, LLC (PanOncology) is a dedicated oncology research site with extensive experience supporting early- and late-phase clinical trials. Our infrastructure, processes, and multidisciplinary team are designed to accelerate study start-up, ensure high-quality execution, and consistently meet enrollment commitments.
Regulatory & Start-Up Excellence
- Extensive experience working with central IRBs (e.g., WCG, Advarra)
- Ability to negotiate budgets and CTAs in parallel with IRB submission
- Ability to execute contracts prior to IRB approval, when permitted
- Efficient management of protocol, ICF, and budget amendments
- Fully inspection-ready regulatory processes
- Ability to perform Accelerated Site Initiation/Study Start-Up processes
Clinical Trial Management System (CTMS) & Digital Infrastructure
- PanOncology utilizes RealTime CTMS
(Copyright © 2005–2026 RealTime — CTMS, eDOCS, eSOURCE, ENGAGE v4.35.4) - Integrated RealTime modules used across all studies:
- CTMS for study, subject, visit, and milestone tracking
- eDOCS / eISF for electronic regulatory binders and essential documents
- eSource for electronic source documentation and study workflows
- ENGAGE for subject engagement, scheduling, and communication
- Embedded EMR/EHR functionality within RealTime to support clinical documentation aligned with research workflows
- System supports:
- Real-time document version control and audit trails
- Remote monitoring readiness and secure document access
- Centralized regulatory, operational, and clinical oversight
- Efficient query resolution and data traceability
Contracting & Budget Experience
- Proven track record negotiating:
- Per-patient and per-procedure budgets
- Start-up, pharmacy, laboratory, imaging, administrative/site fees, etc.
- Collaborative, solution-oriented approach to timely execution
Clinical Operations & Staffing
- Centralized Start-Up, Regulatory, Quality/Compliance, Data Management, Accounting/Finance, Pharmacy and Laboratory Departments/Teams within our organization
- 8 clinical research sites that operate under the PanOncology umbrella
- Dedicated oncology research team including:
- Study / Site Managers
- Senior and Lead Clinical Research Coordinators
- Regulatory Specialists
- Oncology Research Pharmacy and Laboratory Leadership
- Built-in back-up coverage to ensure continuity
- PI selection guided by disease expertise, workload, and investigator interest, led by the Chief Medical Officer (Marcia Cruz-Correa, MD, PhD)
- 14 Investigators (including Medical Hematologists-Oncologists, Gastroenterologists, Dermatologists and Urologists-Oncologists, etc.) that are part of our investigator network
Visit & Study Execution Flexibility
- Experienced in remote, on-site, and hybrid PSVs, PSSVs, PTAs, and SIVs
- Virtual site tours, SOPs, and electronic documentation available
- Rapid readiness for monitoring visits, audits, and inspections
Patient Access & Enrollment Strength
- Access to a diverse oncology patient population
- Strong experience in biomarker-driven trials
- Targeted therapy
- Close collaboration with pathology and molecular diagnostics teams
- Focus on meeting or exceeding PI-confirmed enrollment commitments
Data Quality, Compliance & Inspection Readiness
- Timely data entry and proactive query resolution
- Continuous oversight of source documentation and protocol compliance
- Always audit- and inspection-ready, including support for remote audits
Pharmacy, Laboratory & Logistics
- Oncology research pharmacy expertise:
- IP accountability and reconciliation
- Cold-chain and specialty handling
- Central and specialty laboratory processing and shipment
- Lab kit and supply inventory management
- SensoScientific used to monitor min/max temperatures to avoide excursions
- Ability to perform genetic lab testing
Pan American Center for Oncology Trials, LLC is a proactive, digitally enabled oncology research partner committed to regulatory excellence, operational efficiency, and high-quality clinical trial execution across all phases of development.