Meet Our Contributors
Excelya Authors and Subject Matter Experts
Meet the specialists behind Excelya’s scientific insights, practical guidance, and perspectives across clinical research and evidence generation.
Explore our contributors’ profiles to discover their professional backgrounds, areas of expertise, and published articles across clinical operations, data management, biostatistics, statistical programming, pharmacovigilance and drug safety, medical affairs, regulatory affairs, Real World Evidence, epidemiology, medical writing, and other disciplines supporting clinical research.
Morgane Ballon, PhD
Real World Evidence Biostatistician
Morgane is a PhD-qualified Real World Evidence (RWE) biostatistician and statistical programmer with more than 10 years of experience supporting observational research, healthcare database studies, epidemiology projects, and evidence generation across the life sciences sector. Her expertise spans study design, statistical methodology, and the analysis of real-world data to generate robust evidence that supports healthcare decision-making.
Featured Publication
How to Assess Real-World Data Quality Before Starting Your RWE Study
Learn how to evaluate whether real-world data are fit for purpose and capable of generating reliable evidence for observational research and healthcare decision-making.
Nikitas Nanidis, MD
Global Medical Affairs Director
Nikitas is Director of Global Medical Affairs and a Safety Physician, bringing 21 years of clinical experience, including 12 years at Excelya. His expertise spans roles in medical monitoring, medical writing, safety physician, and medical advisory in clinical strategy, and regulatory pathways, across various therapeutic areas, such as Oncology, CNS, Cardiology, and Immunology
Featured Publication
Prediction Markets and Clinical Trials: Risk to trial Integrity
Explore how prediction markets tied to clinical trial outcomes could introduce new risks for participants, sponsors, CROs, and study teams, while affecting confidentiality, scientific rigour, and confidence in clinical research.
Andrés Malatesta
Biostatistician
Biostatistician and programmer with over five years of experience contributing to more than a dozen clinical trials and real-world evidence studies across oncology, endocrinology, and psychotherapy. Author of five peer-reviewed publications, including two full research articles and three conference abstracts.
Featured Publication
ISS & ISE: How Integrated Clinical Summaries Drive FDA Approval
How pharmaceutical executives can leverage integrated clinical data to accelerate FDA approval timelines, strengthen benefit-risk narratives, and reduce costly submission delays.
Unlocking Real-World Evidence with the OMOP Data Model
Transform real-world data into regulatory-ready evidence with the OMOP Data Model, enabling scalable analytics, standardized data harmonization, and privacy-preserving insights for better healthcare decisions.
Christina Oikonomou
Senior Medical Writer
Medical doctor and Senior Medical Writer with over five years of clinical research and pharmaceutical experience. Her expertise spans regulatory and clinical writing, medical consultation, medical monitoring and pharmacovigilance across oncology, haematology, cardiovascular medicine, immunology and other therapeutic areas.
Featured Publication
The Value of Medical Writer Doctors in Clinical Trials
As clinical development and regulatory requirements grow more complex, Medical Writer Doctors provide the clinical insight and communication expertise needed to deliver high-quality scientific content.
Alexandra Argyraki
Safety Manager at Excelya
Safety Manager with more than 15 years of experience in pharmacovigilance and regulatory compliance, complemented by expertise in data privacy and quality systems. Her experience spans global and local pharmacovigilance operations, clinical safety, risk management, regulatory audits and inspections, quality management systems and patient safety governance.
Featured Publication
SAE Reconciliation in Clinical Trials: Key Challenges
Explore how clinical and safety database reconciliation improves data consistency, regulatory compliance and inspection readiness throughout clinical trials.
Early Phase Clinical Trials: Why Safety Oversight Matters More Than Ever
Early phase clinical trials are where a drug’s future is decided, often on the basis of limited human data and evolving scientific understanding.
Artemis Toumazi
Senior Biostatistician at Excelya
Senior Biostatistician with over 12 years of experience in clinical research, statistical design, analysis, and reporting. Her expertise spans Phase I to IV trials, SAP development, statistical reporting, SAS/R programming, and methodological support, with contributions to Bayesian modeling research.
Featured Publication
R Programming in Clinical Trials: Benefits & Uses
Explore how R programming supports biostatistics, clinical data analysis and regulatory reporting, with insights from Excelya’s Statistics and Programming team.
Bayesian Methods in Clinical Trials: FDA 2026 Guidance
Bayesian methods in clinical trials are becoming increasingly important for pharmaceutical and biotech teams looking to design smarter, more flexible, and more evidence driven studies.
