Expert Interviews
Executing Clinical Trials Across EMEA: Lessons from the Field
Today, ABRS is pleased to interview Ayşe Sinem Demiralp, a Clinical Trial Leader with over 10 years of experience leading Phase II–III clinical trials across the EMEA region.
Ayşe has managed studies in therapeutic areas including Oncology, Immunology, Cardiology, Psychiatry, and Endocrinology, and is recognized for driving efficient study execution through cross-functional leadership, agile site activation, and innovative patient recruitment strategies.
Originally from Turkey, she brings a valuable perspective on conducting clinical trials in multicultural and regulatory-diverse environments.
ABRS:Why did you decide to start working in clinical research?
Sinem: My entry into clinical research was gradual. During my master’s degree, I worked as a laboratory researcher on preclinical pharmaceutical projects, where I was first exposed to SOPs, protocols, and structured workflows through a collaboration between academia, government, and industry.
After completing my master’s, I began my career as a study coordinator, transitioning from preclinical and animal research into Phase III oncology trials. That step-by-step transition marked the beginning of my journey in clinical research.
ABRS: What do you enjoy most about leading clinical trials? What keeps you motivated?
Sinem: Every role in clinical research matters because our work has the potential to change lives. I’ve seen this firsthand—both at the site level and from the operational side.
Early in my career, I worked on pembrolizumab studies for stage IV lung cancer when it was still experimental. Today, it is globally accessible. Having worked closely with patients over several years, I witnessed real improvements in survival and quality of life. That experience continues to motivate me. Helping people is what drives my work.
ABRS: Can you describe a particularly challenging study and what you learned from it?
Sinem: One of the most challenging studies I worked on was a psoriatic arthritis trial in Turkey. Although feasibility had been conducted years earlier, the competitive landscape had changed, and after six months, we had zero enrolled patients.
Strict local regulations prevented advertising, so we conducted in-depth research on patient pathways across different regions. This resulted in the first detailed patient pathway analysis for this indication in Turkey.
Although the study fell behind schedule, we eventually succeeded. The experience taught me that feasibility represents at least 50% of a study’s success—not only for enrollment, but also for logistics, vendors, and operational planning.
ABRS: What advice would you give to someone starting as a Clinical Trial Manager?
Sinem: My key advice is to listen before making decisions. A CTM works with many stakeholders—sponsors, CRAs, investigators, and operational teams—and every situation has context.
Asking “why” repeatedly helps uncover root causes and often leads to simpler, more effective solutions. Being a CTM is not only about KPIs or timelines; it’s about supporting people and enabling teams to succeed.
ABRS: Why is Turkey a strong location for conducting clinical trials?
Sinem: Turkey offers several advantages for clinical research: a large and diverse patient population, efficient regulatory processes, and highly skilled investigators—many of whom are academic leaders and global contributors.
The country’s strategic location between Europe and Asia supports fast logistics, and its strong Phase I infrastructure positions Turkey well for the growing biosimilar space. With many patents expiring and a new wave of biosimilars emerging, Turkey has significant potential to support future clinical development.
We would like to thank Ayşe Sinem Demiralp for sharing her insights and experiences with ABRS. Her perspective highlights the importance of thoughtful leadership, strong feasibility planning, and patient-centered execution in today’s complex clinical research landscape.
We appreciate the opportunity to learn from her journey and her valuable contributions to advancing clinical trials across the EMEA region.