OCREA™ · Oncology Clinical Research Excellence Academy™
Standardizing clinical decision-making across oncology development.
Most pharma training is built for site investigators. OCREA was designed for the professionals who drive drug development decisions — Medical Monitors, Clinical Scientists, and CSLs at sponsor organizations, CROs, and biotech companies who need to operate at the highest level from day one.
Designed to reduce variability in clinical decisions and strengthen regulatory-grade consistency across programs.
A sponsor-level training system designed to develop decision-makers in oncology clinical development
"No structured training existed for the decisions sponsor-side professionals face every day — so I built it."
— Alejandra E. Nieto, M.D., MBA · Founder
Medical Monitor of Record, Lancet Oncol 2009
Most pharma training prepares you to comply. OCREA prepares you to decide — and to defend those decisions in front of your CMO, an IDMC, or an FDA reviewer. Every module is scoped to the judgments that define your role.
Deep technical mastery of safety operations, benefit-risk assessment, and full-cycle phase development — the core competencies of the MM role in oncology trials.
End-to-end clinical trial methodology: from endpoint selection and efficacy reading to cross-functional integration and data interpretation in complex oncology programs.
Site management excellence and field protocol implementation. The sponsor-side skills that define high-performance CSLs in competitive oncology environments.
From cancer biology fundamentals to expert-level decision-making under uncertainty — a logical progression designed to build genuine clinical development competence.
Every module combines conceptual instruction with realistic practice scenarios. Designed to accelerate high-quality clinical decision-making and ensure regulatory-grade consistency across studies. Aligned with ICH E6(R3), FDA/EMA regulatory standards, and Kirkpatrick Levels 1 and 2.
Filter the entire program by role — MM, CS, or CSL. Only the content relevant to your responsibilities is surfaced.
Structured decision frameworks for complex judgment calls — from 6-step SAE assessment to benefit-risk narratives for health authority submissions.
Applied scenario-based questions at each module. Realistic clinical development situations — not abstract trivia. Feedback is immediate and educational.
Real-time dashboard across all 51 modules. The program saves your position automatically — resume from exactly where you left off.
Aligned with ICH E6(R3), FDA Oncology guidance, EMA guidelines, ICH E2A/E2B safety reporting, and EU HTA Regulation (JCA).
Standard 12-week schedule extends to 20 weeks without compromising learning integrity. Fully supported for teams, self-directed learners, and LMS integration.
Certifications are earned by demonstrating applied competence — not just completion. Each level has a defined mastery threshold reflecting the real standards of clinical development practice.
Mastery of oncology science fundamentals and clinical trial methodology. Signals readiness to operate independently in sponsor-side clinical development — SAE review, endpoint interpretation, trial design principles. Awarded on completion of Tracks 1–2 with passing scores across all knowledge checks.
75% threshold · Concept-recall assessmentsApplied clinical judgment across role-specific tracks. Signals demonstrated authority to make and defend complex decisions — benefit-risk under incomplete data, dose modification strategy, regulatory positioning, cross-functional conflict resolution. L2 scenarios require integration of multiple concepts under realistic conditions and direct applicability to real program decisions.
65% threshold · Applied-scenario assessmentsThe highest designation. Signals readiness to lead program design and organizational capability — ODAC preparation, portfolio go/no-go, agency interactions, cross-functional influence under uncertainty. The highest designation in oncology clinical development training. Based on structured facilitation of Decision Consequence Tree scenarios; certified by structured assessment of clinical reasoning, not knowledge recall.
Portfolio review · Facilitated assessmentI was the Medical Monitor of record on the global sunitinib expanded-access trial — 51 countries, over 4,000 patients, published in The Lancet Oncology. I held Clinical Lead on Besponsa (inotuzumab ozogamicin) from the pivotal ALL trial through post-marketing IDMC oversight, and on Lorlatinib through approval and into the CNS toxicity monitoring program. Fifteen years at one of the world's top-5 pharmaceutical companies, spanning Phase 1 through NDA/BLA/MAA submission across solid tumors and hematologic malignancies.
Toward the end of that time, I built the oncology medical monitor training curriculum at Pfizer — because nothing adequate existed. I watched talented MMs, CSs, and CSLs struggle not from lack of ability, but because no structured training had ever been designed for the actual decisions they face. Not for IDMC interactions. Not for benefit-risk under regulatory pressure. Not for the FDA meeting where the data is ambiguous and you speak first.
OCREA is that curriculum, rebuilt from scratch and made available outside of one company. Every framework comes from a real decision I had to make. Every scenario reflects a situation where the ICH guideline wasn't enough. This is operational knowledge — not academic theory.
OCREA™ was developed within Clinical Development to standardize oncology decision-making across programs, roles, and regulatory interactions. The platform integrates scientific training, operational execution, and regulatory alignment into a single capability framework supporting consistent clinical development performance. 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 designed to standardize and elevate clinical decision-making across programs — ensuring regulatory-grade consistency and accelerating development outcomes. By aligning scientific reasoning and operational execution, OCREA reduces variability in clinical decisions and strengthens regulatory defensibility across studies, functions, and organizations.
Whether you're stepping into your first MM role, growing into a senior CS position, or building your team's clinical development capability — OCREA gives you the foundation to operate with confidence in any room.
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