Clinical Study Design & Data Management
End-to-end support from protocol development and eCRF design to database lock. I manage clinical data using EDC systems (REDCap, MaganaMed) and contribute to the design of EDC systems themselves, oversee data monitoring and query resolution, and structure datasets to CDISC standards (SDTM/ADaM), fully compliant with ICH E6(R2) GCP and 21 CFR Part 11. I also support trial design optimisation and patient stratification strategies to accelerate safe and effective therapy development.
Statistical Analysis & Biostatistics
Rigorous statistical analysis of clinical datasets, from hypothesis testing and power analysis to longitudinal, survival, and mixed-effects models. I develop machine learning models to identify disease risk, stratify patients, and uncover patterns in complex biomedical datasets that support precision medicine. I produce Tables, Figures, and Listings (TFLs) for regulatory submissions, and translate results into clear, decision-ready outputs through interactive dashboards and data visualisations.
Regulatory Medical Writing
Authoring and reviewing regulatory documents for pharmaceutical, biotech, and medical device companies, including Clinical Investigation Plans (CIP), Clinical Investigation Reports (CIR), interim reports, periodic safety reports, and clinical study synopses. All deliverables are aligned with ICH, FDA, EMA, and MDR requirements.
Clinical Software & EDC System Design
I help teams build clinical data software that stands up to regulatory scrutiny. Drawing on hands-on work designing a multi-tenant EDC platform, I translate clinical and regulatory requirements into clear software specifications, covering eCRF and data models, roles and permissions, audit trails, electronic signatures, and computerised system validation in line with 21 CFR Part 11, GDPR, and the EMA guideline on computerised systems. I use AI-assisted development workflows to turn requirements into working, well-documented software faster.
Scientific Consulting
Independent scientific advice for research teams, CROs, and industry partners. I support study strategy, critical appraisal of biomedical evidence, data anonymization and privacy compliance (GDPR, HIPAA, EMA Policy 0070), support clinical software vendors with requirements and validation, and provide domain expertise across cardiovascular biology, neurophysiology, and oncology.
Scientific Writing & Publications
Expert preparation of peer-reviewed manuscripts, systematic reviews, meta-analyses, scoping reviews, and consensus documents. With 30+ publications across cardiology, neuroscience, and molecular biology, I bring scientific rigour and clarity to every manuscript, from first draft to journal submission.
Multi-omics Data Analysis
I integrate genomics, transcriptomics, proteomics, and metabolomics data to reveal the molecular drivers of disease and identify potential therapeutic targets. By combining multiple layers of biological information, I build a systems-level understanding of complex phenotypes, supporting biomarker discovery, patient stratification, and the translation of molecular findings into actionable clinical insights.
Mathematical Modeling & Network Analysis
Computational modeling of complex biological systems, with deep expertise in cardiac electrophysiology, including action potential propagation, reentry, and arrhythmia substrates using openCARP. I model ion channel dynamics (Hodgkin-Huxley, Markov-state formalism) and synaptic and neuronal network behaviour. I also construct and analyse biological interaction networks to uncover key regulatory pathways and molecular hubs involved in disease progression and drug response.