A smart and skillful Team, available in Europe and the USA
Since its creation in 2011, ExperTrials conducts international trials from phase I to phase IV, driven by a diligent market access analysis. Our goal is to provide agility, stability, and cost efficiency to all our customers from Lyon, France and Pittsburgh, PA.
OUR VISION
3 simple steps, for better trials
1.
Provide an agile and efficient structure, allowing us to become an extension of your team
2.
Keep a transparent and regular basis communication in all your project steps, to ensure everyone is up to date
3.
Tailor the best solution and mobilize experts to deliver clinical trials to the highest quality.
OUR LEADERSHIP TEAM
Aurélie WEISS-GUIMET
CEO & Founder
Clinical Research Professional with +17 years of experience acquired in pharmaceutical company (Sanofi) and CROs in a wide range of therapeutic areas such as oncology, infectious diseases, gastroenterology, vaccine, cardiology, CNS, and rare diseases for drugs, medical devices and ATMPs. Aurélie founded ExperTrials in 2011 and as a consultant in Clinical Research, providing expertise to support biotech including conduct of clinical gap analysis, preparation of RFP, CRO selection and oversight, set-up and strategic clinical input.
In 2019, ExperTrials became a full-service clinical CRO providing support to startup and midsize Biotech and Medtech in the clinical development of their drug, medical device or ATMP in Europe and in the USA.
Dr Christoph WACHTER, PhD
Chief Scientific Officer
Christoph holds a PhD in Biochemistry and has 30+ years of experience in clinical development management and Regulatory Affairs in global pharma companies (Roche Austria, Torrex-Chiesi Pharma, Merck/Arcana Arzneimittel). He then became the R&D Director and part of the executive board at AOP Orphan Pharmaceuticals. He headed the departments of Clinical and Scientific Affairs (including PV),âš Regulatory Affairs, Quality Assurance, and Pharmaceutical Development and worked on various R&D projects in (haemato-)oncology, pulmonology, neurology, and cardiovascular diseases, ranging from preclinical to clinical phase III.
Before joining ExperTrials in 2019, Christoph was VP of Clinical Operations at an international CRO.
Dr. Elzbieta LECH, MD
Head of Clinical Operations EU
Professional with 20+ years of experience in the pharmaceutical industry in clinical operations and regulatory affairs in various therapeutic areas complementing 7+ years of medical experience as a specialist physician in pediatric anesthesiology and intensive care. Strong leadership experience in clinical research and health care as well as a broad knowledge of drug development process. Enthusiastic leader focused on excellence and quality, with good strategic thinking, planning and organization skills. Elzbieta has a strong experience in various therapeutic areas including immune-oncology & rare diseases.
Ghazala KABANI, BSN, MHS
Head of Clinical Operations US
With 30+ years of industry experience, Ghazala Kabani is a leader in clinical operations within the pharmaceutical industry. She has held leadership roles at global biotech companies including Scynexis, Axovant, Pulmocide, and Novocure, as well as various clinical operations project/study management at Johnson and Johnson, Marshfield Clinic, PPD, RPS (now ICON), and Ockham (now COVANCE). Ghazala's expertise spans therapeutic areas such as GBM, brain metastasis, infectious diseases, oncology in general including hematologic malignancies, immunology, lung transplants, women's health, sleep disorders, dementia, Idiopathic Pulmonary Fibrosis, and pediatrics, and vaccine trials.
With a post-doctorate fellowship from Harvard University, an MHS in Health and Public Policy from Johns Hopkins University, and nursing degrees from the Aga Khan University and Holy Family Hospital, Ghazala possesses a comprehensive skill set for end-to-end clinical development.
Pierre-Marie GOURMOUD, MSc
Global Clinical Project Manager
Graduated with a MSc in life sciences, Pierre-Marie has 12 yearsâ experience in Clinical Research within multiples structures: Academics, CRO or Hospital with a focus on hematologic malignancies including infections in immunocompromised patients (with experience on CAR-T cell) and oncology in general.
Pierre-Marie joined ExperTrials in 2019 and assumed different roles as Clinical Research Associate and Regulatory officer; then Clinical Project Specialist by assisting the CPM. Mid 2022, Pierre-Marie was assigned as Clinical Project Manager for complex clinical trials (phase II and III) in infectious disease and rare disease.
Dr. Andrzej PIOTROWSKI
Head of Pharmacovigilance and Medical Monitoring
Andrzej holds a medical degree from Medical University of Warsaw and a PhD in neuroimaging. He has 22+ yearsâ experience as Medical Monitor and Medical Advisor for pharmaceutical companies such as MSD, Boehringer-Ingelheim and Abbvie. He has a wide-ranging clinical trial experience in adult and pediatric environments in major universities, national health centers, and CROs. Vast expertise in a broad scope of therapeutic areas, particularly pulmonology, oncology, rheumatology, and neuropsychiatry, including various neuropsychiatric scales. Significant research-analytical skills ensuring high-quality services in the execution of medical lead responsibilities.
Sandrine KAHI
Clinical Auditor
Sandrine is a clinical research professional with 21+years of experience. After a 10-year tenure at the Inserm (French Medical Research Institute) in international clinical project management (Phases II and III), Sandrine continued to expand her experience in the field with Paris- and Miami-based company Neovacs for another 8 years.
In the past 5 years, she has been specifically responsible for initiating and overseeing an ongoing international clinical trial in the USA. She is currently a Freelance Certified GCP Auditor and Founder of San.K.Bio Consulting.
Dr. Nathalie VALLE
Head of Quality Assurance, Risk and Compliance
Holding an MSc in Quality Assurance in the pharmaceutical industry and trained Pharmacist, Nathalie has over 20 yearsâ experience in Quality Assurance. She has worked for many years in the mainstream pharmaceutical industry as an auditor/QA Manager and has conducted a variety of Good Clinical Practice, Good Laboratory Practice, Good Manufacturing Practice and ISO audits (around 300 audits) for pharmaceutical and cosmetics companies.
She conducted audits in Europe and worldwide and she is experienced in the development and maintenance of quality management systems and in training.
Anthony BERTHON, PharmD
Head of Market Access/HEOR
Pharmacist specialized in Health Economics & Outcomes Research (HEOR) & Market Access with 11+ yearsâ experience in various therapeutic areas such as Oncology (GIST, RCC, Car-T cells like), Endocrinology / Pharmaceuticals, Diagnostics, Theranostics, Nuclear Medicine, Immunology, Fertility & Contraception, Respiratory / Pharmaceuticals, Biosimilars, Haematology, Cardiology (HBP), Endocrinology (Diabetes), Ophtalmology (AMD), Painkiller, Infectious disease, Respiratory (Cystic fibrosis), Allergen immunotherapy.
Rajhans SHARMA, PhD
Business Developer Officer
Rajhans is a Business Development Officer at ExperTrials, specializing in building strategic partnerships with Biotech and Medtech SMEs, guiding them through their clinical development needs. He holds a Masterâs in Nanotechnology, PhD in Drug Discovery and brings several years of senior research experience with high-impact publications in Virology, Oncology, and Neurodegenerative disease. With over 10 years of expertise, Rajhans evaluates complex life science innovations to extract their commercial relevance for business development.
Being an extension of your team is a great responsibility. So we provide.
In the light of our extensive experience with startups in Biotech and Medtech, we understand more than any other your needs for flexibility and ability to adapt with an optimal budget management.
We know that your timelines are extremely tight in order to get the data needed to support the next round of funding and take the next step in the advancement of your clinical development programme.
That is why our expert team works closely with you to tailor the best solution for each project and to deliver clinical trials of the highest quality.
At ExperTrials, you will find complete solutions for clinical trials of any size, location and type, phase I-IV, drug or medical device and we have significant experience in both pre-approval and post-approval trials.
MEET OUR EXPERTS
OUR OPERATIONAL TEAM(s)
In addition to our strong leadership team, our operational team is comprised of 80+ qualified Senior Clinical Research Associates in Europe and the USA. This extensive partnership ensures top-level expertise for all your clinical trial needs, encompassing Clinical Operations, Regulatory affairs, Quality Assurance, Market Access, and Medical Monitoring.
Senior Experts available
Pennsylvania
Supervised by Ghazala Kabani, Head of Clinical Operations in the US
Lyon, France
Supervised by Christoph Wachter, Head of Clinical Operations EU
Worldwide presence
To cover the main regions of the world, and meet the needs of our clients for global clinical studies, ExperTrials also has 4 long-term partners in Australia, Pakistan, South Africa and Japan.
A WORD FROM OUR CEO, AURĂLIE
Aurélie WEISS-GUIMET, CEO
When I launched ExperTrials in 2011, I hoped to create a company carrying out the highest quality of Clinical Research services, Project Management and reporting. Quality resides essentially in the people doing the work, as well as the processes themselves.
Therefore I had two goals in mind :
1) Create an agile and cost-effective, human-sized, CRO that can adapt to the specific needs of our MedTech and BioTech customers
2) Build a team of highly qualified Clinical Research experts in Europe and the USA, who are fully dedicated to our clientsâ clinical trials
We set up a flexible and cost-efficient structure adapted to small biotech organizations, and we will give your project the focus it may struggle to obtain from a big CRO.
Strong of now 17-year experience in Clinical Operations, and a proficient expertise in regulatory affairs, I have built a strong business over the years.
From clinical development to marketing authorization to post launch activities, we deliver every step of the way. We facilitate your interactions with European Health authorities. We also find innovative pathways which streamline your time-to-market and reduce your time-to-revenue.
