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 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.

Priv. Doz. Dr. med. Ghazaleh Gouya Lechner

Sponsor Oversight & Project Management

Kateryna Uspenska - Team

Kateryna Uspenska

Clinical Project Manager

PhD - Palladin Institute of Biochemistry, Kyiv, Ukraine

Corina Eger-Contawe - Team

Corina Eger-Contawe

Clinical Project Manager

Masters - Biomedical Engineering from the Technical University of Vienna

Vanessa Pühringer - Team

Vanessa Pühringer

Clinical Project Manager

Doctorate - Applied Medical Science from the Medical University of Vienna

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Chloe Ellis

Clinical Trial Assistant

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

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MAX RöSSLER

Senior clinical project manager

PhD in Biology, Genetics from the University of Innsbruck and Vienna

Kerstin Zoidl - Team

Kerstin Zoidl

Senior Clinical Project Manager

MSc. Genetics, University of Salzburg. PhD in Molecular Genetics, University of Queensland

Safety Management

Sabine Anderlik Mussbacher - Team

Sabine Anderlik-Mussbacher

Vigilance Officer

MSc. in Microbiology & Botany from the University of Vienna

Berta Moritz - Team

Berta Moritz

Head of VIgilance

PhD in Zoology & Biochemistry from the University of Graz

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Isabelle le Dren

Vigilance Officer

PhD in Biotechnology from Imperial College, University of London

Medical Writing

Gabriele Berghammer

Medical Writer

Ph.M in Translation from the University of Vienna

Joana Enes - Team

Joana Enes

Medical Writer

PhD in Neuroscience from the Max-Planck Institute

Catarina Carrao

Science Writer

Expert in Biochemistry and Natural Sciences

Bhavna Ylera

Medical Writer

PhD in Life Sciences, Molecular Biology, from CCMB, Jawaharlal Nehru University

Eric Arn

Medical Writer

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

Gertrud Schuster

Medical / Regulatory Writer

PhD in Neuropharmacology from the University of Tübingen, Germany

Data Management

Vadym Slavov - Team

Vadym Slavov

Clinical Data Management

Diplom-Ingenieur (MSc.) from the Technical University of Vienna

Peter Lechner - Team

Peter Lechner

Biostatistics

PhD in Technical Mathematics from the Technical University of Graz

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CODY WICKSTROM

Clinical T. Assistant/ Data Management

MSc. in Medical Biology from the University of Salzburg

Quality Management

Elisabeth Smyczko

Quality management

Mag.rer.nat. in Biology from the University of Vienna - Special field anthropology

Diala Assaf - Team

Diala Assaf

Office Management

BSc. in Economics from the University of Damascus, Syria

Mona Frey

Quality management

PhD. in Molecular Biology from the University of Vienna

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Kateryna Uspenska, PhD

Clinical Project Manager

Kateryna has a background in biochemistry, immunology, and neuroscience with a Ph.D. 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 KG 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.

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Corina Eger-Contawe, MSc

Clinical Project Manager

After earning her degree from the University of California at Santa Cruz in Biochemistry and Molecular Biology, Corina furthered her education in Europe at the Technical University of Vienna with a master’s degree in Biomedical Engineering. Her thesis, completed with the Austrian Institute of Technology‘s Cardiovascular Diagnostics department, focused on the development of algorithms for the analysis of electrocardiography signals.

Prior to working with Gouya Insights, Corina worked as a software engineer in various sectors including Data Analytics and Cybersecurity. Her focus now lies in the fostering of innovative solutions in the clinical drug and medical device sector as a clinical project manager.

Dr. Vanessa Pühringer

Clinical Project Management / Medical Writing

Vanessa has obtained her ‘Doctor scientiae medicae’ in Applied Medical Science in the field of Cardiovascular and Pulmonary Disease at the Department of Clinical Pharmacology after completing her bachelor’s in Medical and Pharmaceutical Biotechnology and master’s in Molecular Biotechnology. She gained extensive experience at pharmaceutical companies as medical advisor and as medical writer in a Corporate Pharmacovigilance Department.

Vanessa joined the team of Gouya Insights in September 2020 in the role of Clinical Project Manager where she ensures accuracy in same in coordination with both internal and external teams and maintains knowledge on all technical areas.

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Chloe Ellis, MSc

Clinical Trial Assistant
Chloe, one of our Clinical Trial Assistants, comes from an international background. After earning a Bachelor´s degree in Biomedical Science at Coventry University, with an Erasmus year at the University of Jaen, she is now completing her Master´s degree in Molecular Biology, Microbial Ecology and Immunobiology at the University of Vienna.
 
As as Clinical Trial Assistant, Chloe works alongside the project management team. She ensures the most effective and efficient conduct of our studies by providing administration and project tracking support, in conjunction with the eTMF filing. Chloe´s knowledge, skills and commitment undoubtedly help us to improve and successfuly complete our projects.

Max Rössler, PhD

Senior Clinical Project Manager

Max is a trained molecular geneticist with a focus on cancer research and DNA metabolism. He has a strong background in clinical research with more thant 12 years of experience. Max´s role at Gouya Insights as a senior Clinical Project Manager, is, the cost and time efficient conduct of high quality clinical trials, in order to ensure a successful implemnentation of the clinical development plan.

Prior to Gouya Insights, Max managed the Cesar Cenntral Office in Vienna. He holds a PhD in BIology/Genetzics from the University of INnsbruck/Vienna as well as a MBA from the University of Krems.

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Dr. Kerstin Zoidl

Clinical Project Manager

Kerstin is an experienced molecular geneticist with expertise in cancer research and epidermal biology. Kerstin joined Gouya Insights as Clinical Project Manager with a view to improve the efficiency of clinical development programs driving scientific innovations into medical solutions. Acting as the sponsors representative, Kerstin directs and coordinates clinical research projects and ensures compliance with protocols and all relevant clinical and regulatory requirements.

In the Cancer and Cell Signalling Laboratory at the Institute for Molecular Bioscience in Brisbane, Kerstin studied the cellular origin of basal cell carcinomas focusing on multipotent stem cells and wound-induced cancer development. Kerstin holds an MSc in Genetics from the University of Salzburg and a PhD in Molecular Genetics from the University of Queensland and completed advanced training courses in business management and clinical monitoring.

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Mag. Sabine Anderlik-Mussbacher

Vigilance Officer

Sabine joined Gouya-Insights in October 2020 to strengthen the Safety Desk including Pharmacovigilance and Medical Device Vigilance. She worked with different pharmaceutical companies in the fields of urology, neurology, ophthalmology and infectious diseases. Sabine gained deep insight into Pharmacovigilance/Medical Device Vigilance during the last five years of conducting clinical trials in oncology.

Sabine who completed her studies in microbiology and botany, is not only interested in scientific research but also in empowering adults in their health literacy by holding lectures about health-related topics.

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Dr. Berta Moritz

Head of Vigilance

Berta Moritz has more than 25 years of experience in the different stages of the Drug Discovery & Development process, in particular process development, clinical research/development and regulatory affairs.

Berta worked in congenital haemostatic disorders, intensive care, pulmonology and oncology. She joins Gouya Insights KG focusing on pharmacovigilance in clinical trials. She holds a PhD in Zoology/Biochemistry from the University of Graz.

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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.

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Mag. phil. Gabriele Berghammer, MA

Medical writing & translation consultancy

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.

 

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Dr. Joana Enes

Medical Writing

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.

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Catarina Carrao

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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Bhavna Ylera

Medical Writer

Bhavna brings over 20 years of experience in the area of clinical trial management in CRO, Pharma industry and R&D in academia.  

She obtained her PhD in India and augmented it with postdoctoral research at the Harvard Medical School in Boston, USA and at the Max Plank Institute of Neurobiology in Germany.  

After switching to clinical research, she gained extensive expertise in coordinating global clinical trials (Phase I to Phase III) for the development of new drugs and therapies for a wide spectrum of indications including oncology, infectious diseases, cardiovascular, immunology, organ transplantation and neurology. She has collaborated effectively with pharma and biotech clients and interfaced with global, multi-disciplinary teams to contribute to clinical development programs which culminated in the approval of multiple novel drugs.

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Dr. Eric Arn

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. 

 

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Dr. rer. nat. Gertrud Schuster

Medical / Regulatory Writer

Gertrud is a biologist by training with specialisation in Neuropharmacology. In 1994, she earned a PhD in Neurophramacology from the University of Tübingen (Germany) where she performed her thesis work.

Gertrud holds about 24 years of experience in different positions within clinical research phase 1 to 4 settings, with more than 18 years as a medical writer in CRO and industry.

She gained extensive experience in the writing and preparation of all clinical documents for the submission to international regulatory authorities according to eCTD requirements and other guidelines.

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Vadym Slavov, MSc

Clinical Data Management

Vadym graduated from the Technical University Vienna in financial and actuarial mathematics which has set the ground to solve not only the technical issues but also logical and statistical processes contributing an essential part for every clinical trial.

He gained his broad approach in programming through different business areas in a banking sector and as lecturer at the University of Vienna. Vadym joined the team of Gouya Insights in July 2020 expanding the focus of the company to the core value of delivering high quality clinical trial data.

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DI Dr. Peter Lechner

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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Cody Wickstrom, MSc

Clinical Trial Assisstant / Data Management

After earning his degree in Biology from Finlandia University in the United States, Cody furthered his education in Austria at the University of Salzburg where her earned a master´s degree in Medical Biology. 

In Salzburg, he performed his master thesis work within the Department of Biosciences – Stem Cell Aging and Longevity Research Group and in cooperation with SPOC labs where his focus was on developing on developing an immune-cytochemical protocol for scaffold-free 3D cell cultures and a standardized method for 3D immunofluorescence imaging. 

At Gouya Insights Kg, Cody works collectively with the project management and data management teams to suport the execution of succesfuls clinical trials.

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Mag.rer.nat Elisabeth Smyczko

Quality Management

Elisabeth has obtained her ‘Doctor scientiae medicae’ in Applied Science in anthropology and Preclinical and Clinical research in drug development at the University of Vienna. 

She gained extensive experience as as Clinical Trial Manager, Project & Quality Manager, Inspector for Clinical Trials and as Managing Director, Consultant. 

Elisabeth joined Gouya Insights in the role of Quality Manager. 

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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.

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Mona Frey, PhD

Quality Management

Mona holds a PhD in molecular biology and has several years of research experience in meiosis/DNA repair. She also has experience in product development (in vitro diagnostics) at the interface between hands-on development and regulatory affairs. Her advanced training in innovation management has also sensitized her to the business perspective and provided her with a basic understanding of business development and innovation and marketing management. 

At Gouya Insights, Mona is the Associate Quality Manager responsible for internal process and quality management. She ensures clear structures and process descriptions that allow the necessary flexibility and leads internal and external audits for quality assurance.