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Eurofins Optimed is a Contract Research Organization (CRO) specialised in early-phase clinical trials. With over 35 years of experience and their own clinical center, the company supports pharmaceutical, biotech and medtech sponsors from study design to clinical execution. Eurofins Optimed provides high quality, end-to-end clinical research solutions with a strong focus on quality, compliance and patient safety.
For over three decades, Eurofins Optimed has orchestrated and executed Clinical Trials on behalf of sponsors from the Pharma, Biotech, Medtech and Foodtech industries in order to help them develop life-saving and life-improving products.
Email : OptimedSales@ba.eurofinseu.com
Phone : +33(0) 4 38 37 27 40
Phone : +33(0) 6 87 76 77 80
Since we focus on Early Clinical Development, we are cognizant of the distinctive importance and the urgency of First-in-Human (FIH) and Early Phase clinical trials. We understand how to meet your every specific technical and operational requirements so that you can make the best science and data-driven go/no-go decisions in a timely manner.
Do not make concessions when it comes to the integrity of your clinical trial. Rigorous regulatory scrutiny is necessary and benefits everyone: patients, sponsors, regulators and clinical trial service providers. Quality transparency and accountability are the cornerstone of our success, and of yours.
- Clinical trial protocol
- Regulatory affairs
- Global trial and site management
- Clinical project management, monitoring and vigilance
- Subject recruitment
- Biometry (Data management, biostatistics and study report)
- Medical writing
- Clinical biology and laboratory operations
- API manufacturing, development and distribution (CDMO)
- Early QT assessment
- Bioavailability/ bioequivalence
- Biosimilars
- Drug/Drug interaction
- Food effect
- Pharmacodynamics
- Pharmacokinetics
- Dose proportionality
- First-in-Human (SAD, MAD)
- Tobacco products
- Vaccines
- Muscle biopsy
- Micro-dosing
- Glucose clamp
- Sleep evaluation
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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.
An in-house multidisciplinary team of experts alongside a large international network of Key Opinion Leaders and specialized investigators enable us to provide GxP-compliant services in all therapeutic fields, including the most challenging indications, like rare disease, oncology, and neuroscience.
Located in Gières, France, our dedicated Clinical Trials Unit supports Phase I and early-phase clinical trials through advanced facilities, experienced clinical teams and rigorous quality standards.
Clinical strategy and trial design are critical to the success of early clinical development. Our scientific, medical and biostatistical experts help sponsors design efficient, data-driven development programmes, from First-in-Human studies through to proof-of-concept.
Translate your research and data into intelligible literature to ensure regulatory success
Specialised in patient recruitment for Phase I and Phase Ib clinical trials, Eurofins Optimed provides tailored recruitment strategies, rapid access to qualified healthy volunteers and efficient patient recruitment solutions across a wide range of therapeutic areas.
High-quality clinical data are essential to the success of any clinical trial. Our clinical monitoring, medical oversight and pharmacovigilance services are designed to ensure patient safety, data integrity and regulatory compliance throughout every stage of clinical development.
Continuous medical oversight to protect subjects and safeguard data quality. Our experienced physicians provide proactive medical oversight throughout your study, from first-subject-in to database lock. We combine real-time clinical judgement with rigorous data review to keep subject safety at the centre of every decision — a particularly critical requirement in early-phase and first-in-human studies.
Expert clinical trial protocol development, protocol optimisation and regulatory submission services to support successful CTA/IND approvals and accelerate clinical development programmes worldwide.
Comprehensive clinical trial management and investigational site management services to support Phase I, Phase II and international multicentre clinical studies from start-up to close-out.
Whether you intend to conduct a single-country, single-site study or an international multicentre study, we can take responsibility for every aspect of it.
Our solutions cover the full range of Phase I clinical trial requirements in France. Based in Gières, Eurofins Optimed is an experienced Clinical Research Organisation (CRO) offering a dedicated clinical research centre and expert support for early-phase clinical studies, from First-in-Human trials to bioequivalence studies.
Delivering Excellence in Early Clinical Development
Our Quality Management System (QMS) has been designed to support the specific challenges of Phase I and Phase II trials.
It is built upon:
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:
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.
In conformity with the provisions of decree no. 2019-15 of 8 January 2019, aimed at eliminating the pay gap between women and men, companies with more than 50 employees must calculate and publish their index for gender equality in the workplace every year.
The result of our gender equality in the workplace index for the year 2025: incalculable.
Indicator 1 – pay gap: not calculable.
Indicator 2 – gap in the rate of individual pay rises: The score obtained is 35/35.
Indicator 3 – percentage of employees having received a pay rise in the year following their return from maternity leave: The score obtained is 0/15.
Indicator 4 – number of employees of the under-represented gender among the 10 highest earners: The score obtained is 5/10.
The index is incalculable because the maximum number of points for calculable indicators is less than 75.
Eurofins Optimed is pursuing its commitment to gender equality, to the equal pay policy it has been pursuing for years and to equal opportunities in its recruitment policy, with no discrimination on the basis of gender in recruitment criteria.
Eurofins is built on values of integrity and reputation. Our clients trust us in areas that are very sensitive for them, and they expect the highest level of integrity, trustworthiness and competence from each Eurofins laboratory and each Eurofins employee.
Compliance with these values and all associated laws, regulations and policies is the outcome of an organisation meeting its obligations, and is made possible and sustainable by embedding this attitude in the culture of the organisation and its people. Embedding compliance in the behaviour of all the people working for an organisation depends above all on leadership and clear values, as well as an acknowledgement and implementation of measures to promote compliant behaviour.
The Group’s Mission, Vision and Values provide the basic foundation of how entities within the Eurofins Group shall do business. Within this framework, we expect our leaders to act as role models for all employees. Within this framework, we expect our leaders to act as role models for all employees. The Group Leadership Charter outlines the behaviour we expect from them.
The Eurofins Group Code of Ethics, as the central compliance document, provides short yet precise high-level instructions for every Eurofins employee. It also outlines how to seek guidance and report breaches of the principles laid out in the code (whistleblowing).
Eurofins’ strong commitment to compliance and ethical behaviour is confirmed and strengthened in a number of more detailed statements and policies, which further expand on the principles laid out in the Eurofins Group Code of Ethics:
All documents listed on this web page are jointly forming the Eurofins Core Compliance Documents.
Eurofins has a Whistleblowing Point of Contact intended to encourage and enable employees and stakeholders to confidentially raise concerns in respect of non-compliance without fear of retaliation, so that Eurofins companies can take prompt action to address inappropriate conduct or actions.
Reporters will always be protected if they have reasonable grounds to believe that the information reported was true at the time of reporting but any abuse of this channel will be prosecuted and can result in a number of negative consequences, including in particular disciplinary action.
The Whistleblowing Point of Contact is accessible via the following link: whistleblowing point of contact
For additional guidance, please see the Eurofins Group Whistleblowing Guidelines.
1 rue des Essarts
38610 Gières - France
+33 (0)4 38 37 27 40
