One-stop shop
Our integrated approach to your product development programme ensures efficient translation from the in-vitro and preclinical stages through to Proof of Concept.
Our integrated approach to your product development programme ensures efficient translation from the in-vitro and preclinical stages through to Proof of Concept.
By virtue of Eurofins’ worldwide network of laboratories and dedicated GxP Pharma sites, underpinned by its robust QA programme, we are in an unrivalled position to undertake internally the entire spectrum of activities required to direct and support clinical trials. This allows us to optimize the time and cost of your clinical development projects.
The Eurofins Optimed team of clinical trial experts is also your point of access to Eurofins’ Biopharma division, a first-class biopharmaceutical outsourcing services organization (Contract Research Organization – CRO and Contract Development & Manufacturing Organization - CDMO), offering a holistic approach to cover the entire chain of compound development in order to maximize your chances to succeed in the clinical stages.
Identifying a customizable model that matches the specific needs and strategy of your trial is a long and complex process.
Our flexible and adaptive approach allows you to work simultaneously with any other service provider of your choice, while ensuring optimal cross-company synergy and full control of your project.
Whether you are the Head of Clinical Operations of a big Pharmaceutical or Medical Device multinational company, or the founder of a small biotechnology start-up, your needs for external support may vary significantly.
Because your project is unique and requires an individual approach, we provide a comprehensive range of bespoke and adaptable solutions on a stand-alone or full-service package basis.
Over the past thirty years, we have gained extensive experience in Early Clinical Development across all therapeutic areas, from conventional FIH (First-into-Human) and phase I trials at our clinical trials unit, through to highly complex, specialized international multi-centre studies in the most challenging indications.
Our Quality Management System (QMS) has been designed to support the specific challenges of Phase I and Phase II trials.
It is built upon:
This model allows us to combine the discipline of a global organization with the agility of a specialized early-phase clinical center.
Our Quality Assurance team coordinates and executes:
Each audit is approached as a value-creation opportunity: we identify risks, anticipate issues, guide continuous improvement, and secure the long-term integrity of your project.
We apply a rigorous methodology to ensure full traceability and efficient resolution of quality events:
Our goal: a controlled and stable environment that continuously strengthens data integrity and participant safety.
We operate with a fully structured, audit-ready electronic Trial Master File (eTMF) compliant with EMA and DIA standards.
Our team ensures:
This ensures a clean, compliant and inspection-ready TMF at any point in time.
Our operations rely on a validated digital ecosystem covering EDC, IWRS, pharmacovigilance, bioanalysis, temperature monitoring, eTMF and internal tools.
Based on GAMP5 and GCP principles, our validation framework guarantees:
We ensure that your data remain accurate, traceable, secured and protected at every stage.
A strong quality system starts with trained and empowered teams.
We have implemented:
Every team member becomes an active contributor to quality.
Because we deliver:
Our strength lies in protecting your volunteers, your data and your study outcomes.
Reliability is our Signature.
We place quality at the center of every process, every decision, and every study we support.
Our goal is to deliver undeniable operational excellence, irreproachable compliance, and a partnership built on trust, expertise and long-term performance.
1 rue des Essarts
38610 Gières - France
+33 (0)4 38 37 27 40