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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 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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Priv. Doz. Dr. med. Ghazaleh Gouya Lechner

Sponsor Oversight & Project Management

Kateryna Uspenska - Team

Kateryna Uspenska

Senior Clinical Project Manager

PhD - Palladin Institute of Biochemistry, Kyiv, Ukraine

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Kerstin Zoidl - Team

Kerstin Peschl-Credner

Director Clinical Operations

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

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Vanessa Pühringer - Team

Vanessa Pühringer

Clinical Project Manager

Doctorate - Applied Medical Science from the Medical University of Vienna

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MAX RöSSLER

Senior clinical project manager

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

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Chloe Ellis

Clinical Project Coordinator

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

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CODY WICKSTROM

Project Manager

MSc. in Medical Biology from the University of Salzburg

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Sven Wagner

Clinical Project Coordinator

PhD in Molecular Neurobiology from the Max Planck Institute for Experimental Medicine

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Katharina Zanitzer

Clinical Project Coordinator

MSc. in Analytical Chemistry from the University of Vienna

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João Grilo

Clinical Project Coordinator

MSc. in Bioengineering from the University of Porto

More About João

Safety Management

Sabine Anderlik Mussbacher - Team

Sabine Anderlik-Mussbacher

Head of Safety

MSc. in Microbiology & Botany from the University of Vienna

More About Sabine
Berta Moritz - Team

Berta Moritz

Vigilance Officer

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

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Medical Writing

Gabriele Berghammer

Medical Writer

Ph.M in Translation from the University of Vienna

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Joana Enes - Team

Joana Enes

Medical Writer

PhD in Neuroscience from the Max-Planck Institute

More About Joana

Catarina Carrao

Science Writer

Expert in Biochemistry and Natural Sciences

More About Catarina

Bhavna Ylera

Medical Writer

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

More About Bhavna

Eric Arn

Medical Writer

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

More About Eric

Caroline Bäumler Klestil

Medical Advisor

Doctor of Medicine (MD) from Heidelberg University

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Data Management

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Peter Lechner

Biostatistics

PhD in Technical Mathematics from the Technical University of Graz

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Alexander KÖtzl

Associate Datamanager

Cand.BSc. in Biomedical Engineering at the Technical University of Vienna

More About Alexander

Quality Management

Diala Assaf - Team

Diala Assaf

Office Management

BSc. in Economics from the University of Damascus, Syria

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Mona Frey

Quality management

PhD. in Molecular Biology from the University of Vienna

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Kateryna Uspenska, PhD

Senior 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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Dr. Kerstin Peschl-Credner

Director Clinical Operations (on maternal leave)

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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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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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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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.

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Cody Wickstrom, MSc

Project Manager

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.

Sven Wagner, PhD.

Clinical Trial Assistant

After completing his training as a chemical and biological technical assistant, Sven gained 2 years of work experience at the Institute of Pharmacology and Toxicology at Saarland University. Subsequently, he obtained both a Bachelor’s and a Master’s degree in Human and Molecular Biology at Saarland University.

During his studies, he was able to gain valuable experience in different research groups, such as the Institute of Pharmacology at Heidelberg University and the Center for Integrative Physiology and Molecular Medicine at Saarland University. Thus, he has 14 years of practical experience, as well as a broad spectrum of methods in basic science research. Sven’s focus is on molecular biology and neurosciences. Furthermore, he obtained a PhD in molecular neurobiology at the Max Planck Institute for Experimental Medicine.

At Gouya Insights KG, Sven works as a Clinical Trial Assistant. Here he supports the project managers in start up execution and close out of clinical trials. Due to his experience helps us to successfully complete our projects.

Katharina Zanitzer, Msc

Clinical Trial Assistant

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 Trial Assistant at Gouya Insights, Katharina works with the project management and pharmacovigilance team to support the effective and safe execution of clinical trials.

João Grilo, MSc.

Clinical Trial Assistant

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 CTA at Gouya Insights KG, João coordinates clinical study documentation, data tracking, and clinical supply management. Furthermore, João supports the scientific data mining for bridging the gap between new investigational medical products and pathologies of potential target.

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Mag. Sabine Anderlik-Mussbacher

Head Of Safety

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

Vigilance Officer

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. 

 

Dr. Caroline Bäumler Klestil

Medical Advisor

Caroline 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, where she focused on defects in apoptotic pathways that lead to autoimmune disease and familial lymphoma. She received professional training in internal medicine at the University Hospital in Cologne, Germany and Kaiser Franz Josef Spital in Vienna, Austria.

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 I to market approval in different oncological indications including pediatric and orphan indications.

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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.

Alexander Knötzl

Associate Datamanager

Alex is currently studying in the master’s degree programme in Biomedical Engineering with a specialisation in Mathematical & Computational Biology at the Technical University Vienna. Currently he is working on his Bachelor’s thesis in Statistics & Economical mathematics. Working in the office management of a top tier law firm he acquired many different skills including HTML Programming.

As an associate in Datamanagement, Alex works alongside the Project- and Datamanagement to ensure successful execution in capture, review and analysis of clinical trial data. With his objective orientated programming and strong logical problem solving mindset he designs the database, the user interface to enable capturing the expected outcome of the clinical projects

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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.