The only structured training program built specifically for Medical Monitors, Clinical Scientists, and Clinical Science Liaisons in pharma and biotech oncology development — designed by a physician with 16+ years of industry experience.
OCREA is not a generic GCP refresher. Every module is scoped to the decisions and responsibilities that define your role in clinical development — from individual SAE assessment to regulatory strategy and executive communication.
Deep technical mastery of safety operations, benefit-risk assessment, and Phase 1 dose escalation — the core competencies of the MM role in oncology trials.
Tracks 1–6, 8–9 · ~30 modules
End-to-end clinical trial methodology: from endpoint selection and efficacy reading to cross-functional integration and data interpretation in complex oncology programs.
Tracks 1–6, 8–9 · ~30 modules
Site management excellence, field protocol implementation, and the cross-functional leadership skills that define high-performance CSLs (Clinical Science Liaisons) in competitive oncology environments.
Tracks 1–2, 6–7 · ~15 modules
From cancer biology fundamentals to expert-level decision-making under uncertainty — a logical progression designed to build genuine clinical development competence, not box-checking compliance training.
Every module combines conceptual instruction with realistic practice scenarios. The program is aligned with ICH E6, FDA/EMA regulatory standards, and the Kirkpatrick evaluation model at Levels 1 and 2.
Filter the entire program by your role — Medical Monitor, Clinical Scientist, or CSL. Only the modules and content relevant to your responsibilities are surfaced, so there's no noise.
Structured decision frameworks for the most complex judgment calls in oncology development — from 6-step SAE assessment to benefit-risk narrative construction for health authority submissions.
Applied scenario-based questions at each module. L1 and L2 questions use realistic clinical development situations, not abstract trivia. Feedback is immediate and educational.
Track completion across all 37 modules with a real-time progress dashboard. The program saves your position automatically — resume from exactly where you left off.
Content is aligned with ICH E6(R3), FDA Oncology guidance, EMA oncology guidelines, ICH E2A/E2B safety reporting standards, and the EU HTA Regulation (Joint Clinical Assessment).
The standard 12-week schedule can extend to 20 weeks without compromising learning integrity. Adaptations are fully supported for small teams, self-directed learners, and resource-limited settings.
Certifications are earned by demonstrating applied competence — not just completion. Each level has a defined mastery threshold designed to reflect the real standards of clinical development practice.
Demonstrates mastery of oncology science fundamentals and clinical trial methodology. Awarded on completion of Tracks 1–2 with passing scores across all knowledge checks.
Demonstrates applied clinical judgment across role-specific tracks. L2 scenarios require integration of multiple concepts under realistic conditions — deliberately more complex than L1.
The highest designation. Based on structured facilitation of Decision Consequence Tree scenarios and portfolio review — no single correct answer, certified by structured assessment of clinical reasoning.
OCREA was created out of a direct observation: most oncology clinical development training is either too generic, too basic, or designed for site staff — not for the sponsor-side professionals who drive drug development decisions every day.
The program is built on 16+ years of senior oncology clinical development experience at a top-5 global pharmaceutical company, spanning Phase 1 through registration trials, multi-regional submissions, and IDMC operations across solid tumors and hematologic malignancies.
Dr. Nieto has served as Global Clinical Lead and Senior Clinical Director in oncology, with direct experience in benefit-risk assessment, regulatory interactions with FDA and EMA, safety aggregate review, and cross-functional team leadership across multiple oncology programs.
Every framework, scenario, and module has been validated against real operational challenges — the kind that don't appear in ICH guidelines but define the quality of clinical development practice in the field.
OCREA is operated under AH Investments LLC and is protected under U.S. copyright law (17 U.S.C. § 504). All 16 proprietary frameworks are trade secret protected.
OCREA is available for individual enrollment and organizational licensing. Reach out to discuss program access, team pricing, or LMS integration.
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