Deep Therapeutic & Geographic Experience
With over 13 years of hands-on operational leadership across diverse therapeutic areas and international markets, Mariliam brings battle-tested expertise to your clinical program. Our experience spans early-phase to late-stage development across four continents.
Therapeutic Areas
🎗️ Oncology
Extensive experience in cancer clinical trials with focus on solid tumors and operational excellence in competitive enrollment environments.
- Ovarian Cancer: Phase II trials with comprehensive CRO oversight and study team management
- Study Phases: Phase II operational leadership
- Key Activities: Timeline management, budget accountability, CRO oversight, site management
🧠 Neurology
Strategic operational planning for neurodegenerative and movement disorder programs with complex patient populations.
- Parkinson's Disease: Phase II program operational and country-selection strategy
- Study Phases: Phase I-II development programs
- Key Activities: IND preparation support, protocol design input, enrollment feasibility assessment
🦠 Infectious Diseases
Rapid deployment expertise in emerging infectious diseases and vaccine development across global settings.
- COVID-19: Phase I severe COVID-19 trial planning, implementation, and execution
- RSV (Respiratory Syncytial Virus): Phase II-III maternal immunization studies across multiple continents; global lead CRA role
- Ebola: Phase II study project leadership
- Sepsis: Observational studies in Cambodia, Ghana, and Liberia with program management responsibilities
🔬 Autoimmune & Endocrine Disorders
Alliance partnership management and operational oversight for rare autoimmune conditions requiring specialized expertise.
- Myasthenia Gravis: Alliance partner relationship management for clinical-stage programs in Japan
- Thyroid Eye Disease: International partnership oversight and operational execution
- Graves' Disease: Multi-country program management and strategic alliance coordination
👁️ Ophthalmology
Late-stage trial management for ophthalmologic conditions with CRO and external consultant oversight.
- Dry Eye Disease: Phase III US-based clinical trial CRO management
- Study Phases: Phase III pivotal trials
- Key Activities: External consultant management, budget ownership, quality compliance
💉 Vaccine Development
Large-scale global vaccine trials with maternal immunization specialization and multi-site coordination.
- RSV Maternal Immunization: Global lead CRA for Phase III study with 90+ sites across North America, South America, Asia-Pacific, and Europe
- RSV in Older Adults: Lead unblinded CRA for Phase II studies
- Key Activities: Global site selection, investigator meeting leadership, CRO oversight, data management
Global Footprint
International Trial Management Experience
Extensive history of managing trial sites and strategic alliances globally with direct operational experience across four continents. Proven ability to navigate diverse regulatory environments, cultural considerations, and logistical challenges in international clinical research.
🌎 North America
- United States: Extensive site management across multiple therapeutic areas
- Key Activities: FDA regulatory interactions, site identification, CRO oversight
- Specialization: Lean biotech operational execution
🌏 Asia-Pacific
- Japan: Alliance partner relationship management across multiple clinical-stage programs (Myasthenia gravis, Thyroid eye disease, Graves' disease)
- Cambodia: Program management for observational Sepsis study
- Regional Expertise: Phase III RSV vaccine trial site selection and management
🌍 Europe
- European Union: Multi-country Phase III RSV maternal immunization study execution
- Key Activities: Global investigator meetings, site selection, regulatory coordination
- Specialization: Cross-border trial logistics and compliance
🌍 Africa
- Ghana: Sr. Regulatory Affairs Specialist/Lead CRA for observational Sepsis study
- Liberia: Observational study operational management
- Key Activities: In-country project management, inventory/supply chain, site training
🌎 South America
- Regional Coverage: Phase III RSV maternal immunization trial site management
- Key Activities: Site identification, feasibility assessment, enrollment strategy
- Specialization: Multi-country coordination and oversight
📊 By the Numbers
Global Sites Managed
Continents
Countries
Phase & Study Type Experience
Phase I
- SAD, MAD, and Food Effect studies in healthy volunteers
- Severe COVID-19 patient trials
- IND preparation and submission support
Phase II
- Oncology (ovarian cancer)
- Neurology (Parkinson's disease)
- Infectious diseases (RSV, Ebola)
- Operational and country-selection strategy
Phase III
- Global RSV maternal immunization (90+ sites)
- Dry eye disease US-based trials
- Alliance partnership management
- Large-scale CRO oversight
Leverage Our Global Experience
Whether you're planning a single-country study or a complex multi-regional trial, Mariliam's proven international expertise ensures seamless execution across diverse regulatory and cultural landscapes.
Discuss Your Program