ExperTrials
ExperTrials is a European-based, global Contract Research Organization (CRO) dedicated to assisting biotech and medtech companies in launching their innovative drugs or medical devices with agility and high standards. Founded in 2011 by Aurélie Weiss-Guimet, it offers comprehensive clinical trial services across Europe and the USA, including clinical operations, regulatory affairs, medical monitoring, pharmacovigilance, data management, biostatistics, and market access. The company emphasizes a small, agile structure with a strong leadership team and a network of over 80 senior clinical research experts, supporting international trials with local expertise. ExperTrials aims to be a strategic partner for biotech startups, providing tailored solutions, maintaining high quality, and fostering innovation in clinical research.
Industries
Nr. of Employees
small (1-50)
ExperTrials
Villeurbanne, Rhone-Alpes, France, Europe
Services
End-to-end operational delivery for clinical studies (Phase I–IV) including study management, monitoring, site oversight and a dedicated project manager with team continuity.
Regulatory strategy development, dossier preparation and submission support for European and US regulatory frameworks, including CTIS/CTR readiness and local country documentation.
Provision of senior medical monitors and outsourced pharmacovigilance services to manage patient safety, safety reporting and inspection readiness.
Electronic data capture implementation, database management and statistical analysis to support trial integrity, reporting and adaptive trial designs.
QA program development, internal and external GCP audits, and inspection readiness support to address regulatory compliance gaps and follow-up actions.
Health economics and outcomes research, payer evidence planning and reimbursement strategy to support product launch and pricing discussions.
End-to-end operational delivery for clinical studies (Phase I–IV) including study management, monitoring, site oversight and a dedicated project manager with team continuity.
Regulatory strategy development, dossier preparation and submission support for European and US regulatory frameworks, including CTIS/CTR readiness and local country documentation.
Provision of senior medical monitors and outsourced pharmacovigilance services to manage patient safety, safety reporting and inspection readiness.
Electronic data capture implementation, database management and statistical analysis to support trial integrity, reporting and adaptive trial designs.
QA program development, internal and external GCP audits, and inspection readiness support to address regulatory compliance gaps and follow-up actions.
Health economics and outcomes research, payer evidence planning and reimbursement strategy to support product launch and pricing discussions.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions (EU CTR / CTIS and US filings)
- Pharmacovigilance and medical monitoring
- Clinical data management and biostatistics
Key Technologies
- Clinical Trial Information System (CTIS)
- Adaptive trial design methodologies
- Decentralized and hybrid trial platforms (remote monitoring)
- Real-world evidence generation
News & Updates
Interview with Ghazala Kabani, Head of Clinical Operations in the U.S. at ExperTrials. She shares her extensive experience and her role in the company.
Celebrating 12 years of providing high-quality clinical research services since its founding in 2011.
ExperTrials is the chosen CRO for Scynexis, Inc. for their phase II trials and for Vanda Pharmaceuticals, Inc. for a pivotal phase III study.
Aurélie Weiss-Guimet, CEO of ExperTrials, discusses the future of clinical trials, the role of CROs, and the company's international expansion.
An overview of why ExperTrials maintains a small size to stay agile and serve small biotech companies, focusing on innovation and personalized service.
Interview with Ghazala Kabani, Head of Clinical Operations in the U.S. at ExperTrials. She shares her extensive experience and her role in the company.
Celebrating 12 years of providing high-quality clinical research services since its founding in 2011.
ExperTrials is the chosen CRO for Scynexis, Inc. for their phase II trials and for Vanda Pharmaceuticals, Inc. for a pivotal phase III study.
Aurélie Weiss-Guimet, CEO of ExperTrials, discusses the future of clinical trials, the role of CROs, and the company's international expansion.
An overview of why ExperTrials maintains a small size to stay agile and serve small biotech companies, focusing on innovation and personalized service.