Gouya Insights Clinical Development Logo
Book a Free Expert Hour

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.

Phone-alt Envelope Linkedin
Download CV

Team

Divider
Kateryna Uspenska leads clinical trial management and clinical project management, guiding sponsors through study protocol design, regulatory compliance, and clinical study execution from concept to final study report.

Kateryna Uspenska

Senior Clinical Project Manager

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

More About Kateryna
Alfred Gugerell leads project management for cell-based therapies, regenerative medicine, and drug development, bringing CMC, quality management, and clinical trial expertise to guide sponsors through complex biotech and pharma projects.

Alfred Gugerell

Senior Clinical Project Manager

PhD in Biology from the University of Vienna

More About Alfred
Joana Enes brings 15+ years of research and drug development experience across neurology, cardiology, and oncology to deliver expert medical writing that supports clinical research and regulatory submissions

Joana Enes

Medical Writer

PhD in Neuroscience
from the Max-Planck Institute

More About Joana
Pavol Csiba supports clinical trial execution and clinical operations, bringing eTMF/CTMS systems management and process expertise from both sponsor and CRO sides to keep trials running efficiently from feasibility through close-out.

Pavol Csiba

Clinical Project Manager

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

More About Pavol
Katharina Zanitzer supports clinical trial execution and pharmacovigilance, bringing analytical chemistry expertise and CMC management support to help sponsors run safe, streamlined clinical trials.

Katharina Beer

Clinical Project Manager

MSc in Analytical Chemistry
from the University of Vienna

More About Katharina
Diala Assaf delivers office management and administrative support that includes budgeting, correspondence, and records management for the team.

Diala Assaf

Office Management

BSc in Economics
from the University of Damascus, Syria

More About Diala
Martin Völkl delivers clinical data management, using eCRF software and custom data pipelines to ensure accurate, complete, and safe capture of clinical trial data.

Martin Völkl

Clinical data manager

MSc in Chemistry
from the University of Vienna

More About Martin
Liudmyla Glazunova delivers strategic and operational planning of research activities, project and innovation management

Liudmyla Glazunova

Clinical Project Coordinator/ eTMF Administrator

PhD in Social Communication from
State Academy of Culture, Kharkiv, Ukraine

More About Liudmyla
frederique lacomte serves as a Clinical Research Associate and Clinical Project Manager.

Frédérique Lecomte

Clinical Research Associate / Clinical Project Manager

Master of Arts in University of Vienna

More About Frédérique

Barbara Grohmann-Izay

Quality Expert and Vigilance Officer

MD from Medical University of Vienna,
MSc in Psychology from University of Vienna

More About Barbara

Mariceles Mendoza

Medical Device Regulatory Affairs and Regulatory Compliance

JD, Universidad de Carabobo, Valencia, Venezuela

More About Mariceles

Nora Gedeon

Data Protection Officer (DPO) and Vendor Manager

MSc in Chemistry
from the University of Vienna

More About Nora

Biostatistics

Divider
Peter Lechner, Biostatistics, Senior Consultant

Peter Lechner

Biostatistics

PhD in Technical Mathematics from the Technical University of Graz

More About Peter
Logo LGS-Insights

RADKA ŠTĚPÁNOVÁ

Biostatistics

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

More About Radka

Non-Clinical Expert Network

Divider

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
PHOX Consulting partner logo
gouya-insights-NETWORK-Anika-Schröter-Dr.-rer.-Nat.

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
Dr. Anika Schroeter partner logo
Kateryna Uspenska leads clinical trial management and clinical project management, guiding sponsors through study protocol design, regulatory compliance, and clinical study execution from concept to final study report.
Envelope Phone-square-alt Linkedin

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 wet laboratory.

At Gouya Insights, Kateryna holds a senior leadership role in clinical project management, providing strategic oversight of complex clinical research studies. She serves as a trusted partner to study sponsors and oversees cross-functional clinical teams, ensuring the successful planning, execution, and delivery of clinical trials throughout the entire study lifecycle.

Kateryna also acts as a Strategic Clinical Development Consultant, contributing to clinical development strategies, operational feasibility, regulatory considerations, optimize study design and execution strategies, mitigate operational risks, and support informed decision-making throughout the product development.

Kateryna serves as Chair of the Young Professionals Working Group (YPWG) of the International Federation of Associations of Pharmaceutical Physicians and Pharmaceutical Medicine (IFAPP).

Alfred Gugerell leads project management for cell-based therapies, regenerative medicine, and drug development, bringing CMC, quality management, and clinical trial expertise to guide sponsors through complex biotech and pharma projects.
Envelope Linkedin

Alfred Gugerell, MSc PhD Priv.-Doz.

Senior Project Manager

Alfred is a biologist by training, specializing in anthropology and human biology, with extensive experience in both academic and private research. He holds a PhD in Biology and completed his habilitation at the Medical University of Vienna. His expertise spans cell and molecular biology, wound healing, tissue regeneration, tissue engineering, cell-based therapies, drug development, and clinical trials. Over the course of his career, he has expanded his focus from research into clinical development, regulatory affairs, and project leadership.
As a Senior Project Manager at Gouya Insights, Alfred provides project management, clinical and regulatory consulting, medical writing, and pharmacovigilance support for biotech and medtech companies, helping to translate scientific innovations into successful clinical development programs.

Joana Enes brings 15+ years of research and drug development experience across neurology, cardiology, and oncology to deliver expert medical writing that supports clinical research and regulatory submissions
Envelope Linkedin

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.

Pavol Csiba supports clinical trial execution and clinical operations, bringing eTMF/CTMS systems management and process expertise from both sponsor and CRO sides to keep trials running efficiently from feasibility through close-out.
Envelope Linkedin

Pavol Csiba

Clinical Project Coordinator

Pavol holds a master’s degree in organic chemistry from the Slovak University of Technology. During his academic research, he focused on synthesizing heterocyclic molecules for potential applications in human medicine. With comprehensive experience from both the Sponsor and CRO sides, he has gained expertise in clinical operations, quality management, and the improvement of clinical systems and processes.

At Gouya Insights, Pavol drives the strategic planning and execution of clinical trials, leading operational activities across cross-functional teams. He is dedicated to operational excellence and on-time delivery, ensuring that client objectives are consistently met. Additionally, Pavol supports quality management and business development activities.

Katharina Zanitzer supports clinical trial execution and pharmacovigilance, bringing analytical chemistry expertise and CMC management support to help sponsors run safe, streamlined clinical trials.
Envelope Linkedin

Katharina Beer, Msc

Clinical Project Coordinator

Katharina holds a master’s degree in Analytical Chemistry from the University of Vienna in 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.

At Gouya Insights, Katharina works closely with the Clinical Project Management and Pharmacovigilance teams to ensure the effective, compliant, and safe execution of clinical trials. Additionally, Katharina supports CMC projects and laboratory coordination.

Diala Assaf delivers office management and administrative support that includes budgeting, correspondence, and records management for the team.
Phone-square-alt Envelope Linkedin

Diala Assaf, BSc

Office Management

Diala holds a bachelor’s degree in economics from the University of Damascus, Syria, and has been working as Office Manager at Gouya Insights since June 2020. Prior to joining Gouya Insights, she gained experience in administration, finance, and customer service through her role as a bank employee at Arab Bank Syria.

At Gouya Insights, Diala oversees the day-to-day office operations and provides comprehensive administrative support. Her responsibilities include handling invoices and office budgets, maintaining company records, coordinating administrative activities, managing HR processes, and ensuring the smooth and efficient functioning of the office

Martin Völkl delivers clinical data management, using eCRF software and custom data pipelines to ensure accurate, complete, and safe capture of clinical trial data.
Envelope Linkedin

Martin Völkl, Msc

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.

Liudmyla Glazunova delivers strategic and operational planning of research activities, project and innovation management
Envelope Linkedin

Liudmyla Glazunova, PhD

Clinical Project Coordinator/ eTMF Administrator

Liudmyla holds a PhD in Social Communication from State Academy of Culture, Kharkiv, Ukraine and served as Deputy Director for Research at the Korolenko State Scientific Library in Kharkiv, Ukraine. In this role, she gained extensive experience in strategic and operational planning of research activities, project and innovation management, and the organization and moderation of international conferences. In academic and scientific libraries of Ukraine, she was engaged in archiving and cataloging documents/artifacts, metadata Management, bibliometric and scientometric research.

Following her relocation to Vienna, she worked as an eTMF Administrator at ProFem GmbH from 2022 to 2024.

At Gouya Insights, Liudmyla serves as an eTMF Administrator, where she is responsible for the maintenance and continuous quality assurance of the electronic Trial Master File (eTMF) in accordance with the TMF Reference Model. Her responsibilities include ensuring the completeness, consistency, and GCP compliance of all study documentation; reviewing documents for accuracy, version control, and archiving requirements; and supporting study teams with document uploads, indexing, and overall eTMF management.

Envelope Linkedin

Frédérique Lecomte, MA

Clinical Research Associate / Clinical Project Manager

With 15 years of experience in clinical research, Frédérique offers a wide-ranging skill set covering regulation submissions, site oversight, and the development of essential study documents. Having recently joined the company and the team at Gouya Insights, she serves as a Clinical Research Associate and Clinical Project Manager. Her responsibilities at Gouya Insights are to maintain strong, steady relationships with study sites and to communicate easily with staff members. Supporting study sites as much as possible so they can conduct studies smoothly, confidently and successfully is an important matter to her; and supporting the Operational team with study start-up activities.

Envelope Linkedin

Barbara Grohmann-Izay, MD, MSc

Quality Expert and Vigilance Officer

Barbara brings more than 25 years of experience in clinical research, in the area of Pharmacovigilance, Medical Affairs, Quality Management, Clinical Operations & Development, Medical Writing, and Biostatistics. Her extensive background across diverse therapeutic areas and company structures enables her to adapt quickly and add strategic value in complex environments. She holds a medical degree (Medical University of Vienna), an MSc (Psychology, University of Vienna), and has completed a postgraduate program in Clinical Research.

Envelope Linkedin

Mariceles Mendoza

Medical Device Regulatory Affairs and Regulatory Compliance

Mariceles Mendoza brings over 30 years of experience in the life sciences industry, specializing in regulatory compliance, quality assurance, and quality management systems. She has supported medical device, IVD, and pharmaceutical manufacturers in meeting global regulatory requirements and navigating complex transitions such as EU MDR/IVDR and ISO 13485:2016. Mariceles is passionate about building robust quality systems and ensuring compliance across international markets.

Envelope Linkedin

Dr. Nora Gedeon

Data Protection Officer (DPO) and Vendor Manager

Nora holds degrees in law from Janus Pannonius University and in pharmacy from Semmelweis University, combining legal and scientific expertise. She is a certified Data Protection Officer with hands-on experience supporting GDPR compliance and contractual safeguards for biotech and pharma clients. With over 20 years in clinical research, she brings a pragmatic, risk-aware approach to data protection in global trials

Peter Lechner, Biostatistics, Senior Consultant
Envelope

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.

Envelope Linkedin

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.

gouya-insights-NETWORK-Volker-Blust-Dr.-rer.-Nat.
Envelope Linkedin
PHOX Consulting partner logo

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. 

gouya-insights-NETWORK-Anika-Schröter-Dr.-rer.-Nat.
Linkedin
Dr. Anika Schroeter partner logo

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.  

Envelope Linkedin

Dr. Nora Gedeon

Data Protection Officer (DPO) and Vendor Manager

Nora holds degrees in law from Janus Pannonius University and in pharmacy from Semmelweis University, combining legal and scientific expertise. She is a certified Data Protection Officer with hands-on experience supporting GDPR compliance and contractual safeguards for biotech and pharma clients. With over 20 years in clinical research, she brings a pragmatic, risk-aware approach to data protection in global trials