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About Eurofins Optimed SAS

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.

Locations

Gières

Laboratory

1, rue des Essarts, 38610 Gières, France

Laboratory

+33 (0)4 38 37 27 40

optimedsales@ba.eurofinseu.com

Gières

Laboratory

1 rue des Essarts, 1 rue de la Condamine, 38610 Gières, France

Laboratory

+33 (0)4 38 37 27 40

optimedsales@ba.eurofinseu.com

Eurofins Optimed

An eminence in Clinical Trials

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.

Contact Us

Email : OptimedSales@ba.eurofinseu.com

Phone : +33(0) 4 38 37 27 40

Phone : +33(0) 6 87 76 77 80

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Specialised in Early Clinical Development

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.

 

Commitment to Quality and Compliance

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.

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Full-Service Clinical CRO

A-to-Z, from protocol design through to study report, Eurofins Optimed is your fully customizable one stop-shop spanning the entire ecosystem of clinical research solutions.

- 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)

2025-06-04
Clinical Trials Unit (CTU)

Dedicated to early clinical development in healthy volunteers and ambulatory patients.

- 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

Our clinical trial solutions

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We know how much is at stake for sponsors, patients, physicians, and regulators.

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.

 

One-stop shop or pick and mix services.

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.

Our services

Eurofins’ Clinical Trials Unit (CTU)

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2500 m2 exclusively dedicated to early clinical development

Strategically located a stone's throw away from some of the most important healthtech hubs in Europe, our facilities are exclusively dedicated to conducting clinical trials

Clinical trials technical expertise

We have decades of experience managing and monitoring trials across a wide range of therapeutic areas.

24/7 Medical Supervision

We guarantee the presence of one of our qualified doctors 24/7.

Regular inspections & licence Renewal

Our facilities, equipment and personnel are regularly audited and inspected by the competent authorities in order to renew all the relevant accreditations.

Emergency Procedures

We have carefully designed an emergency plan alongside the Grenoble University Hospital (CHU de Grenoble)

Training and Equipment

We invest in specialized training & in the most modern and sophisticated medical equipment, materials, and technology to ensure highly performing and safe clinical operations in any therapeutic field.

Protocol Development and trial design

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We develop scientifically robust clinical trial protocols

Our scientists, biostatisticians and medical experts provide strategical and methodological advice based on strong evidence in order to help you plan coherent and robust studies, mitigate risk, optimize resources and make the best possible data-driven decisions.

 

Protocol optimization

We also analyze and review your own design and assumptions from a scientific, cultural, operational, and regulatory perspective in order to ensure that they are consistent with the objectives and endpoints of your study.

Our Medical Director, Dr Yves Donazzolo, is an active member of some prestigious Independent Clinical / Scientific advisory boards and has overseen thousands of development programmes.

We can help you with:

Selection of clinical endpoints

Protocol - writing and review

Sample size calculation

Literature search and review

Regulatory Affairs

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Avoid costly compliance roadblocks

We help you navigate the increasingly complex and ever-changing regulatory labyrinth in order to eliminate surprises and meet your key milestones on time and on budget.

Worldwide regulatory compliance

Our regulatory experts continuously monitor country-specific regulatory & ethics restrictions and requirements and liaise with all relevant stakeholders so that submissions are always fully compliant.

Meet the regulatory authorities

We support and accompany you to meetings with international, national and regional regulatory authorities (FDA, EMA, MHRA, AIFA, AEMPS, Swissmedic etc.)

Medical writing

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Translate your research and data into intelligible literature to ensure regulatory success

With strong scientific backgrounds and knowledge of GCP and ICH guidelines, our medical writers produce high quality, evidence-based scientific, technical, medical and regulatory documents for a broad variety of promoters across all therapeutic areas.

Our custom approach allows us to use in-house or sponsor-supplied document templates. All the documents we produce undergo rigorous scientific, statistical, editorial and quality control reviews to ensure content, format, and style conformity in order to meet global technical and regulatory requirements.

We can help you with:

Investigators’ brochures (IB)

Investigational Medicinal Product Dossier (IMPD)

Synopsis / Protocol and amendments

Informed Consent form / Patient Information

Case Report Form / Patient Diary

Clinical study report in line with ICH E3

Vigilance documents, safety reports, narratives and updates

Interim report

Participation in abstracts / posters / publications

Global Trial and Site Management

Quality Assurance

Delivering Excellence in Early Clinical Development

A Robust, Agile and Purpose-Built Quality Management System

Our Quality Management System (QMS) has been designed to support the specific challenges of Phase I and Phase II trials.

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It is built upon:

  • International regulations and guidelines (ICH-GCP, EMA, FDA, GDPR)
  • A harmonized and controlled documentation framework
  • Strong operational procedures refined through extensive field experience
  • A risk-based, forward-looking approach to quality and compliance

This model allows us to combine the discipline of a global organization with the agility of a specialized early-phase clinical center.

Audits That Drive Performance

Our Quality Assurance team coordinates and executes:

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  • Comprehensive internal audits (processes, TMF, pharmacy, laboratory, IT, safety, operations…)
  • Qualification and oversight of critical vendors (data management, statistics, pharmacovigilance, bioanalysis, computerized systems…)
  • Inspection readiness and support during regulatory inspections (ANSM, EMA, FDA…)
  • Sponsor audits with consistently high satisfaction

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.

Deviation Management, CAPA and Continuous Improvement

We apply a rigorous methodology to ensure full traceability and efficient resolution of quality events:

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  • Structured identification and documentation of deviations
  • Root-cause analysis using proven tools (5 Why, Ishikawa, risk assessment)
  • Development of corrective and preventive action plans that are relevant, measurable and actionable
  • Verification of effectiveness to guarantee long-lasting improvement
  • Cross-department communication to prevent recurrence

Our goal: a controlled and stable environment that continuously strengthens data integrity and participant safety.

Document Excellence and TMF Mastery

We operate with a fully structured, audit-ready electronic Trial Master File (eTMF) compliant with EMA and DIA standards.

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Our team ensures:

  • TMF completeness and real-time accuracy
  • Consistency of documentation and metadata
  • Proper version control and change traceability
  • End-to-end compliance with EU CTR 536/2014 requirements

This ensures a clean, compliant and inspection-ready TMF at any point in time.

Validated and Secure Computerized Systems

Our operations rely on a validated digital ecosystem covering EDC, IWRS, pharmacovigilance, bioanalysis, temperature monitoring, eTMF and internal tools.

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Based on GAMP5 and GCP principles, our validation framework guarantees:

  • Prospective and lifecycle-based validation of each system
  • Structured change control and documentation
  • Logical and physical security, cybersecurity, and backup/restore testing
  • Full data integrity (ALCOA+) from creation to archiving
  • Regular audits of critical IT vendors

We ensure that your data remain accurate, traceable, secured and protected at every stage.

Training, Competency and Quality Culture

A strong quality system starts with trained and empowered teams.

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We have implemented:

  • A comprehensive onboarding program for all new employees
  • Mandatory and recurrent training on GCP, EU CTR, SOPs and internal systems
  • Competency tracking based on real study experience
  • A culture of ownership, transparency and continuous improvement

Every team member becomes an active contributor to quality.

Why Sponsors Trust Us


Because we deliver:

  • Complete visibility and proactive communication
  • Solution-oriented support, not just compliance checks
  • Early-phase expertise with integrated operations
  • Fast, transparent and rigorous quality management
  • Risk anticipation, not risk reaction
  • Quality that secures timelines, cost, and scientific robustness

Our strength lies in protecting your volunteers, your data and your study outcomes.

Quality is our Commitment.

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.

Index for gender equality in the workplace

for the year 2025 based on 2024 data

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.

Contact us

2025-06-04

EUROFINS OPTIMED CLINICAL RESEARCH

1 rue des Essarts
38610 Gières - France

+33 (0)4 38 37 27 40

mailto:optimedsales@ba.eurofinseu.com

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To help us better understand your project, please let us know details such as the type of study, number of subjects (patients or healthy volunteers), number of investigational sites and countries involved, expected start date, study duration, and estimated number of monitoring visits.

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