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Over 20 Years of Medical and Scientific Expertise

With serendipity, enthusiasm and openness for innovation in healthcare, the Gouya Insights team retains passion for innovation and the trust of our customer as its core values.

Priv. Doz. Dr. med. Ghazaleh Gouya Lechner

Founder, Strategic Specialist

As founder of the Gouya-Insights, Ghazaleh Gouya Lechner takes leadership in clinical development for biotechnology, pharma and medical device companies across Europe. She aims to address clinical product development and regulatory compliance challenges. Her expert team of scientists and medical experts in life science research are the foundation of the company’s success. The team’s multidisciplinary skillsets grant Gouya Insights the ability to efficiently navigate their clients from discovery through to testing, clinical trials, regulatory approvals, and market launch.

Ghazaleh Gouya Lechner, MD, is board certified in internal medicine, cardiology and clinical pharmacology, with more than 20 years of clinical research experience. She was awarded the title Associate Professor for Internal Medicine from the Medical University Vienna, and has worked at a global CRO as Medical Director. Ghazaleh has been involved in numerous product development processes. She substantially contributes to any product strategy and protocol development by identifying and documenting the best ways to help patients, and ultimately receiving market approval for the products she works with.

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Team

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Sandra Scheidl, Director Clinical Program, Management Department

Sandra Scheidl

Director clinical program

MSc in IT in Healthcare and Life Science
from the Danube University Krems

More About Sandra

Alfred Gugerell

Senior Project Manager

PhD in Biology from the University of Vienna

More About Alfred

Caroline Bäumler Klestil

Head of Medical & Scientific Writing

MD in Human Medicine
from Heidelberg University

More About Caroline
Mona Frey, Quality Manager, Management Department

Mona Frey

Quality manager

PhD in Molecular Biology
from the University of Vienna

More About Mona
Kateryna Uspenska, Senior Clinical Project Manager, Clinical Operations

Kateryna Uspenska

Senior Clinical Project Manager

PhD in Biochemistry from Palladin Institute of Biochemistry, Kyiv, Ukraine

More About Kateryna
João Grilo, Clinical Project Coordinator, Clinical Operations

João Grilo

Clinical Project Coordinator

MSc in Bioengineering
from the University of Porto

More About João
Katharina Zanitzer, Clinical Project Coordinator, Clinical Operations

Katharina Zanitzer

Clinical Project Coordinator

MSc in Analytical Chemistry
from the University of Vienna

More About Katharina
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Pavol Csiba

Clinical Project Coordinator

MSc in Chemistry and Chemical Technology
from the Slovak University of Technology

More About Pavol
Chloe Ellis, Clinical Project Coordinator, Clinical Operations

Chloe Ellis

Clinical Project Coordinator

BSc in Molecular Biology, Microbial Ecology & Immunobiology from the University of Vienna

More About Chloe
gouya-insights-CLINICAL-OPERATIONS-Martin-Völkl-MSc

Martin Völkl

Associate clinical data manager

MSc in Chemistry
from the University of Vienna

More About Martin
Isabelle Le Dren, Vigilance Officer, Clinical Operations

Isabelle le Dren

Vigilance Officer

PhD in Biotechnology
from Imperial College, University of London

More About Isabelle
Diala Assaf, Office Management, Management Department

Diala Assaf

Office Management

BSc in Economics
from the University of Damascus, Syria

More About Diala
Joana Enes, Medical Writer, Scientific & Medical Writing

Joana Enes

Medical Writer

PhD in Neuroscience
from the Max-Planck Institute

More About Joana
Catarina Carrão, Medical Writer, Scientific & Medical Writing

Catarina Carrão

Medical Writer

Expert in Biochemistry
and Natural Sciences

More About Catarina
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Eric Arn

Medical Writer

PhD in Molecular Biology and Biochemistry from the California Institute of Technology

More About Eric
Gabriele Berghammer

Gabriele Berghammer

Medical Writer

Msc in Translation & Interpretation from the University of Vienna

More About Gabriele
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Biostatistics

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Peter Lechner, Biostatistics, Senior Consultant

Peter Lechner

Biostatistics

PhD in Technical Mathematics from the Technical University of Graz

More About Peter
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RADKA ŠTĚPÁNOVÁ

Biostatistics

MSc in Computational Biology at the Masaryk University in Brno, Czech Republic

More About Radka

Non-Clinical Expert Network

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Volker Blust

Nonclinical-toxicology consultant
Owner of phox consulting e.u.

Dr. rer. Nat. in Food Chemistry & Toxicology
from the University of Vienna

More About Volker
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Anika Schröter

nonclinical-toxicology consultant
Owner of dr. Anika schroeter e.u

Dr. rer. Nat. in Chemistry & Toxicology
from the University of Vienna

More About Anika
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Gouya Insights, 2024©

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Sandra Scheidl, Director Clinical Program, Management Department
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Sandra Scheidl, Msc

Director Clinical Program

Sandra joined Gouya Insights as Director Clinical Programs in January 2023. With more than two decades of clinical experience not only with large pharmaceutical companies, but also academia and smaller MedTech companies specializing in clinical research and development, Sandra brings a wealth of experience to expand Gouya Insights’ clinical development consulting and services.

Her primary focus is on providing medical device development and launch services in Europe, the United States and the APAC region. At her previous employers, Sandra was also a driving force in obtaining ISO and CE certifications.

Sandra holds a Master of Science in IT in Healthcare and Life Science, which she obtained at Danube University Krems.

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Alfred Gugerell, MSc PhD Priv.-Doz.

Senior Project Manager

Alfred is a biologist by training, specializing in anthropology and human biology. During his career as a scientist, he has gained experience in cell biology and molecular biology in both academic and private research. His research covers topics such as wound healing, tissue regeneration, tissue engineering, cell-based therapies, secretome-based therapeutic approaches, drug development, and clinical trials. He also has experience in CMC (chemistry, manufacturing, and controls), quality management, and data protection. Alfred joined Gouya Insights KG in 2024 as a senior project manager. 

Caroline Bäumler Klestil, Head of Medical & Scientific Writing, Senior Consultant
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Caroline Bäumler-Klestil, MD

Head of Medical and Scientific Writing, Medical Advisor

Caroline joined Gouya Insights as a medical adviser and is leading the medical writing team.

She has a strong background in immunology and cancer research. She earned her MD degree from Heidelberg University and the German Cancer Research Center in Germany followed by postdoctoral studies at Cornell University in New York. Her work was focused on defects in apoptotic pathways that lead to autoimmune disease and familial lymphoma.

Prior to Gouya Insights, Caroline worked for several years as medical affairs and drug safety officer for Apeiron Biologics in Vienna where she gained extensive experience in various phases of clinical trials from phase 1 to market approval in different oncological indications including pediatric and orphan indications.

Mona FreyMona Frey, Quality Manager, Management Department
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Mona Frey, PhD

Quality Manager

As Quality Manager, Mona is responsible for process and quality management at Gouya Insights. She ensures clear structures and process descriptions that allow the necessary flexibility and leads internal and external audits for quality assurance. She is trained in ISO 9001 and as a GCP auditor and is therefore the contact person for all quality related questions for all projects of Gouya Insights and the guide through the regulatory framework.

Mona has a PhD in molecular biology and has many years of research experience. She has also gained experience in product development (in vitro diagnostics), at the interface between hands-on development and regulatory affairs. Her training in innovation management has made her sensitive to the business perspective and she has a fundamental understanding of business development, innovation and marketing management.

Kateryna Uspenska, Senior Clinical Project Manager, Clinical Operations
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Kateryna Uspenska, PhD

Senior Clinical Project Manager

Kateryna has a background in biochemistry, immunology, and neuroscience with a PhD. from the Palladin Institute of Biochemistry, Kyiv, and 8 years hands-on experience in a laboratory, including in the neurobiology laboratory at the Institut Pasteur, Paris, and at the Institute of Physiology, Tübingen. Kateryna’s scientific interests focused on neurodegenerative diseases and nicotinic addiction. Kateryna is a member of rthe Society of Clinical Research Associates.

In Gouya Insights GmbH & CoKG Kateryna acts as a liaison between the study sponsor and the clinical study team. As a clinical project manager, she is involved in planning and managing all aspects of clinical projects: from concept through study report completion. Her major priority is to ensure studies are carried out according to the study protocol and authority regulations and to offer strategic solutions to execute clinical trials successfully.

João Grilo, Clinical Project Coordinator, Clinical Operations
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João Grilo, MSc

Clinical Project Coordinator

João moved to Vienna in the end of 2017 to start his PhD in immunology at the Medical University of Vienna. He earned experience in both humoral and cellular responses in allergy. Moreover, he holds a Master in Biological Engineering from the University of Porto, Portugal, which focused on research and manufacturing within the Pharma and Food industries.

As a CPC at Gouya Insights GmbH & CoKG, João coordinates clinical study operations (project management, site management, monitoring).  Furthermore, João supports intra-Sponsor and Sponsor-Vendor cross-functional interactions through meeting coordination, therapy program management and scientific data mining, paving the way to first interventional studies.

Katharina Zanitzer, Clinical Project Coordinator, Clinical Operations
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Katharina Zanitzer, Msc

Clinical Project Coordinator

Katharina earned her master’s degree from the University of Vienna in Chemistry, focusing on Analytical Chemistry. In her thesis she focused on mass spectrometric analysis of phase II metabolites of testosterone in terms of anti-doping analysis. Working as a technical assistant in a WADA accredited anti-doping laboratory, she gained a lot of experience concerning analysis of small molecules in human urine samples.

As a Clinical Project Coordinator at Gouya Insights, Katharina works with the project management and pharmacovigilance team to support the effective and safe execution of clinical trials. Furthermore, Katharina supports streamlined development of emerging projects with Chemistry, Manufacturing, and Controls (CMC) Management.

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Pavol Csiba

Clinical Project Coordinator

Pavol earned his master’s degree from the Slovak University of Technology in chemistry and chemical technology, majoring in organic chemistry. He has most experience in clinical operations (feasibility to close-out) and clinical process and systems management (KPI and metrics setup, eTMF/CTMS planning and development), from both Sponsor and CRO.

At Gouya Insights, Pavol works as Clinical Project Coordinator supporting execution of clinical trials.

Chloe Ellis, Clinical Project Coordinator, Clinical Operations
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Chloe Ellis, BSc

Clinical Project Coordinator
Chloe successfully earned her Bachelor’s degree in Biomedical Science from Coventry University, enriching her academic journey with an Erasmus year at University of Jaén. Currently, she is diligently pursuing her Master’s degree in Molecular Biology, Microbial Ecology and Immunobiology at the University of Vienna.

Commencing her professional journey in 2021, Chloe, in her role as a Clinical Project Coordinator, oversees the execution of studies, ensuring they maintain the highest standards of quality. She adeptly utilises project tracking tools to streamline the process. With a keen focus on Trial Master File Administration, Chloe meticulously documents each facet of the projects.

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Martin Völkl, Msc

Associate Clinical Data Manager

Martin completed his MSc in chemistry at the University of Vienna, where he focused on Bioinformatics, Data Science and Data Analysis. For his master’s thesis he benchmarked several linear optimization algorithms intended for metabolic modeling applications, such as the elucidation of important metabolic pathways or optimization of product synthesis in complex biological systems.

His education and personal interest enabled him to acquire a solid foundation in programming as well as the analytical mindset and diligence needed for clinical Data Management. In his current position he manages various eCRF software to ensure accurate and reliable capture of clinical trial data and designs data processing and visualization pipelines to continuously monitor the completeness, safety, and plausibility of the entered data.

Isabelle Le Dren, Vigilance Officer, Clinical Operations
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Isabelle Le Dren, PhD

Vigilance Officer

Isabelle Le Dren holds a PhD in Biotechnology from Imperial College (University of London) and has more than 15 years of pharmacovigilance expertise throughout the product life cycle within the pharmaceutical industry.

She worked in all areas of pharmacovigilance including as auditor, and she held the position of QPPV. She joined Gouya Insights KG in 2020 focusing on pharmacovigilance in clinical trials.

Diala Assaf, Office Management, Management Department
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Diala Assaf, BSc

Office Management

Diala holds a bachelor’s degree in economics from the University of Damascus in Syria and joined Gouya Insights in June 2020.  She worked previously as bank employee at Arab Bank Syria in the field of customer service and relationships, where she gained deep knowledge in accounting and administration. 

Diala ensures the smooth running of the office on a day-to-day basis and provides administrative support by organizing meetings and managing databases, dealing with correspondence, complaints and queries, managing office budgets, and keeping personnel records up to date.

Joana Enes, Medical Writer, Scientific & Medical Writing
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Joana Enes, PhD

Medical Writer

Joana earned her PhD in Neuroscience from Max-Planck Institute (Germany) in 2010 and conducted postdoctoral studies at Brandeis University in Boston (U.S.A).

Altogether, she brings more than 15 years of research experience in key therapeutic areas, such as neurology, cardiology and oncology.

Following her interest in Drug Discovery & Development, she later worked at a clinical research consulting firm in Boston. She moved to Austria in 2017 and joined Gouya Insights in June 2018.

Catarina Carrão, Medical Writer, Scientific & Medical Writing
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Catarina Carrão, Msc

Science Writer

Catarina is a Biochemist with extensive biomedical research experience from different international academies (e.g., Yale University, Charité Medical University).

In 2016, she founded BioSciPons, a life science communication agency focused on bridgeing the gap between science and the people, academia and business. 

She is an expert in conveying complex scientific messages in a simple way; and, was awarded European Science Slam of the year in 2012, and nominated Young Science Journalist of the Year (2021) by the ABSW.

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Eric Arn, PhD

Medical Writer

Eric Arn holds a PhD in Molecular Biology and Biochemistry form the California Institute of Technology. His academic research career brought him to positions at various universities across the United States, to the Max Planck Institute in Germany, and finally to the Medical University of Vienna.

Since 2007, he has shifted his focus to providing freelance science and medicine-related English language services including writing, editing, translating, and communication training.

At Gouya Insights, Eric will be responsible for medical writing. 

Gabriele Berghammer
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Gabriele Berghammer, Msc

Medical writer

Gabriele holds degrees in translating & interpreting from both the University of Vienna, Austria, and the Monterey Institute of International Studies (MIIS), California, USA, focusing on medical communication from the very outset of her professional career.

Before founding the text clinic, a boutique medical writing & translation consultancy, in 2006, she held various positions as healthcare communicator, most recently as regulatory writer in the international clinical development department that brought forth the world’s first biosimilar.

A stint into the software industry as technical writer and positions as multilingual translation manager and lead translator have rounded off her IT and documentation expertise.

Looking back on 30 years of experience as a medical communicator, Gabriele delights in using her skills to produce documents in accordance with what she has termed the ‘seven Cs of medical writing,’ i.e., texts that are carefully researched, correct and accurate, consistent, clear and concise, compellingly structured, compliant with relevant guidelines, and cut and tailored to their respective target audiences.

Peter Lechner, Biostatistics, Senior Consultant
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Peter Lechner, PhD

Biostatistics

Peter Lechner holds a PhD in Technical Mathematics. After his academic career he worked for leading international companies in various managing positions. He gathered profound expertise in trial designs and statistical analysis including regulatory requirements as well as data management and related IT services.

In 2014 Peter Lechner founded LGS-Insights e.U. The company offers services in all phases of research and development from phase I clinical analysis to post-marketing services for a wide range of therapeutic areas. The key expertise covers the spectrum from trial design to statistical analysis and data management.

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RADKA ŠTĚPÁNOVÁ

Biostatistics

Radka Štěpánová is a biostatistician who currently holds the position of Head of statistics and SAS programming at ANOVA CRO. She completed her MSc in Computational Biology at the Masaryk University in Brno, Czech Republic.

As a biostatistician who has been working in the field of clinical trials for more than 10 years, she has a lot of experience in handling various statistical activities from the preparational phase of clinical trials to reporting and interpretation of study results (Phase I-IV interventional studies, NIS, research projects & grants). This experience also covers successful submissions of the study results to the regulatory authorities (FDA, EMA, PMDA) for product approval.

Her practice includes studies from several clinical scenarios in international and local clinical trials. As a statistician of the Sleep Apnea in Post-Acute Myocardial Infarction Patients study she underwent a stay at Mayo Clinic in Rochester, USA. During her studies, she underwent an internship at the Institute of Social and Preventive Medicine at the University of Zurich, Switzerland, where she became a member of a team of biostatisticians with a specialization in disease mapping of oncological diagnoses and she improved her knowledge, especially in this field of study.

She is the author or co-author of tens of scientific publications in the field of clinical research.

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Volker Blust, PhD

Senior non-clinical & toxicology expert

Volker is a senior non-clinical and toxicology expert with 10+ years of experience in the pharmaceutical and medical device industry. He started his career in 2013 as a consultant for non-clinical development and biocompatibility at MC Toxicology Consulting GmbH, where he worked on a range of drug products (small molecules, biologics, vaccines) and medical devices (substance-based devices, biodegradable implants). 

In 2021 Volker founded PHOX Consulting e.U. (Vienna, Austria), where he supports his clients in all phases of non-clinical development. This includes the strategic conception of product-tailored development programs and approval-strategies, design and monitoring of non-clinical studies, coordination of scientific advice meetings and acting as a key-representative for customers during interactions with authorities. He has extensive experience in the writing and compilation of regulatory documents (Briefing Documentation, IB, IND/CTD) and provides ad-hoc toxicology advice (risk assessments, deficiency letters, impurity qualification). 

Volker studied food chemistry at the Karlsruhe Institute of Technology in Germany and completed his doctoral studies (Dr. rer. nat.) in the field of toxicology at the University of Vienna, Austria. In 2018 he received his certificate as a European Registered Toxicologist. Since 2018, Volker has been a lecturer at “Forum Institute for Management” in the field of non-clinical drug development. 

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Anika Schröter, PhD

Non-clinical & toxicology consultant

Anika Schröter is a non-clinical and toxicology consultant with 10 years of experience in the field of drug development. She started her career in the consultancy company MC Toxicology GmbH (Vienna), where she gained profound expertise in the development and conduct of product-tailored non-clinical plans, regulatory interactions, risk assessments and regulatory writing. In 2021, she founded her own company in Vienna (Dr. Anika Schroeter e.U.) offering consultancy services around the non-clinical development of biologicals and small molecules with specific focus on regulatory-compliant toxicology testing.  

Anika is certified as European Registered Toxicologist (ERT) and holds a Diploma degree in the field of biology from the University in Dresden (Germany) and a PhD (Dr. rer. nat.) in the field of biology / toxicology from the University of Vienna (Austria). In addition, Anika is working as a lecturer in advanced education courses providing insights into specifics of non-clinical drug development.