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 in healthy volunteers and in ambulatory patients and is fitted out with the most sophisticated medical equipment and clinical technology

Clinical trials technical expertise

We have decades of experience managing and monitoring trials across a wide range of therapeutic areas. Despite our state-of-the-art know-how, we know that in Health innovation complacency in expertise will not suffice if you are to stay on top of your game. 

We take therefore every opportunity to continuously upgrade our soft and hard skills by taking on the most technically complex trials, on the most challenging therapeutic indications and requiring the latest and most innovative technology and techniques.

24/7 medical supervision

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

• 60 beds for hospitalized volunteers
• Large ambulatory area (1200 m2),
• On-site access-controlled pharmacy
• On-site laboratory for biological samples management
• Temperature-controlled storage equipment (+4°C, -20°C and -80°C) 
• Last but not least, a very friendly team of doctors, nurses, lab technicians and specialised cleaning and maintenance staff.

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), which includes:

• Training of the head of the resuscitation unit on the protocols of every trial conducted at our clinical trials unit.
• A dedicated direct emergency line and emergency plan activation code.
• A yearly emergency plan drill exercise.

Training and equipment

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

Clinical trial protocol

We develop scientifically robust clinical trial protocols.

Our scientists and medical experts provide strategic and methodological advice grounded in strong evidence — helping you plan coherent, robust studies, mitigate risk, optimise resources and make the best possible data-driven decisions.

Early-phase development is about generating decision-grade data efficiently — not about formal powering. Our scientific, medical and biostatistical experts help you de-risk the critical early choices: the dose, the design, and the regulatory pathway.

We support you with:

• Integrated early development strategy: defining the most efficient route from preclinical data to proof-of-concept, aligned with your Target Product Profile.
• Regulatory scientific advice: preparing and supporting EMA Scientific Advice, national competent authority interactions, FDA pre-IND / Type B meetings, and CTA/IND-enabling documentation. 
• First-in-human design: pharmacologically-anchored / MABEL-based starting-dose justification, dose-escalation strategy (rule-based or model-based/Bayesian), sentinel dosing and integrated stopping rules, in line with the EMA FIH guideline. 
• Adaptive & seamless designs: SAD/MAD, integrated Phase 1/1b, dose-finding and expansion cohorts to reach decisions faster. 
• Proof-of-mechanism & Proof-of-concept (Phase 1b): early signal detection in patients, with rigorous cohort and population selection. 
• Translational & model-informed support: PK/PD interpretation and exposure-response insight, delivered together with our preclinical and pharmacokinetics partners to strengthen your dose rationale. 
• Endpoint & biomarker strategy: selecting exploratory and early-efficacy endpoints that are fit for decision-making.
• Proportionate, objective-driven sizing: sample sizes scaled to the exploratory question, not to late-phase power calculations. 
• Scientific literature & competitive landscape review.

Protocol optimisation

We also review your own design and assumptions from a scientific, cultural, operational and regulatory perspective, ensuring they remain consistent with your study's objectives and endpoints.

Our medical & scientific leadership

• Dr Lila Krebs-Drouot, our Medical Lead, combines a dual background in medicine and clinical research, with a strong focus on translational development. She works closely with sponsors to bridge early science and clinical proof-of-concept, ensuring that biological rationale, dose strategy and early endpoints are aligned from the very first studies in humans.
• Dr Yves Donazzolo, pharmacologist and founder, supports our teams in a scientific consulting capacity. With over 30 years of experience and as an active member of prestigious independent clinical and scientific advisory boards, he has overseen thousands of development programmes and brings deep pharmacology expertise to the design and review of your early-phase studies.

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 sponsors 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 Reports
• Participation in Abstracts, Posters and Publications
• Regulatory Briefing Documents / Briefing Packages
• Plain Language Summaries / Lay Language Documents
• DSURs (Development Safety Update Reports)
• RMPs (Risk Management Plans)
• Laboratory Manuals
• Pharmacy Manuals

Personalised and Efficient Recruitment Strategy

We provide a personalised assessment of each study's recruitment requirements at an early stage and identify potential challenges to optimise timelines and control costs. We use a wide range of recruitment tools to design tailored and effective recruitment campaigns, including: phone calls, local media advertising, flyers, email marketing, social media campaigns and SMS outreach. 

Pre-qualified Pool of Healthy Volunteers and Specific Populations

Our dedicated recruitment team understands volunteers' motivations and concerns, enabling effective engagement and retention throughout the study.  We continuously update our proprietary database of over 30,000 healthy volunteers, whom we qualify through comprehensive questionnaires and medical examinations conducted by our medical staff. They can be classified according to population-specific criteria depending on your protocol's eligibility requirements — for example, smoking habits, ethnicity or hormonal status.

Ethical, Compliant and Inclusive Recruitment

Our recruitment capabilities combine traditional outreach methods with digital recruitment tools, allowing us to efficiently identify, engage and retain suitable participants while ensuring full compliance with GDPR requirements and the highest standards of data privacy and confidentiality. We are committed to supporting diversity and inclusion in clinical research and work with sponsors to develop recruitment strategies that promote representative study populations whenever appropriate. To protect participant safety and data integrity, robust over-volunteering control procedures are implemented throughout the recruitment and screening process. Our team can also support sponsors with the preparation of recruitment-related documentation for Ethics Committees, Competent Authorities, Institutional Review Boards (IRBs) and Comité de Protection des Personnes (CPP), including recruitment materials, advertisements and participant-facing documents.

Informed Consent and Participant Inclusion

An initial pre-screening process enables us to identify and contact potential participants. We first conduct a telephone interview to assess willingness to participate, availability and compliance with the study inclusion criteria. Volunteers who successfully complete the pre-screening phase undergo a comprehensive medical assessment and a face-to-face interview to confirm their eligibility and ensure they fully understand all relevant aspects of the study before signing the Informed Consent Form (ICF). 

Worldwide Patient Recruitment

Through our extensive network of Key Opinion Leaders and specialised investigational sites worldwide, we are also able to recruit patients across a broad range of therapeutic areas, including complex indications such as rare diseases, oncology and neuroscience.

Thorough Medical Oversight: The Only Road to Safety

From protocol development and study design through to study close-out, medical oversight of all stages and activities of your clinical trial is of prime importance to meet your objectives while ensuring the integrity of your data. You are likely to require assistance in order to:

• Provide input into clinical development plans, protocol designs and risk assessments
• Train and support investigational sites on potential subject safety issues, subject rights and medical emergencies
• Review and enhance the quality of study deliverables
• Verify the consistency and accountability of your data
• Process SAEs, manage medical coding and write safety narratives
• Prepare for or participate in DSMB meetings

Compliance, Compliance and More Compliance to Mitigate Risk

We are highly conscious of the importance of demonstrating your commitment to patient safety to regulatory authorities. In order to demonstrate the therapeutic potential of your product, you require fully compliant and high-quality bespoke vigilance and safety solutions that enable you to comply with the strictest regulatory requirements, manage the benefit-risk profile of your product and ensure patient safety.

Dedicated Clinical Research Associates (CRAs)

Our in-house team of CRAs receives continuous training to ensure they remain knowledgeable and up to date with the latest techniques, technologies and regulatory developments. A Lead CRA dedicated to your study directs a team of field-based CRAs and oversees all monitoring activities carried out at participating investigational sites.

Risk-Based Monitoring Plan

We carefully design a risk-based monitoring plan, which serves as the framework for all monitoring activities. We focus on detecting, mitigating and preventing errors that may create risk, improving patient safety and enhancing the reliability of your clinical data. A patient-centric and proactive early-detection approach minimises risk and enables effective and efficient solutions.

Remote Monitoring

When appropriate, we utilise virtual monitoring technology, allowing CRAs to perform monitoring activities remotely and reducing the significant costs and downtime associated with travel.

Stay Ahead of Vigilance Regulatory Requirements and Avoid Unnecessary Costs and Delays

Strict compliance with vigilance procedures and ICH Good Clinical Practice requirements helps minimise unnecessary costs and delays. Our team of vigilance specialists, comprising physicians, pharmacists and life sciences professionals, works closely with sponsors, investigators and regulatory authorities to effectively monitor, assess and report safety data in a timely and compliant manner.

Our capabilities include:

• Vigilance consulting
• EU QPPV and Local QPPV activities
• Pharmacovigilance System Master File (PSMF)
• Safety Data Exchange Agreements (SDEAs)
• Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS)
• SAE and SUSAR monitoring, reporting and follow-up 24/7
• SOP development and support
• Vigilance training
• Safety database management (set-up, maintenance, etc.)
• Preparation for audits and inspections
• CAPA management
• EudraVigilance
• Benefit-risk assessment

Proactive safety oversight

Our medical monitors work hand-in-hand with investigators and the clinical team, available to answer eligibility and protocol questions and to support medical decision-making in real time. In dose-escalation and first-in-human trials, they contribute to sentinel dosing oversight, stopping-rule assessment and the safety reviews that gate progression to the next cohort.

Ongoing medical data review

Beyond individual case management, we review safety data on a continuous and trend-based level — laboratory values, ECGs, vital signs and adverse events — to detect emerging signals early and protect the integrity of your dataset.

We can help you with:

• Medical and eligibility review, protocol deviation assessment
• Real-time medical support to investigational sites
• Ongoing review of safety data (labs, ECG, vital signs, AEs)
• Adverse event and SAE medical assessment — seriousness, causality, expectedness
• Dose-escalation decisions and Safety Review Committee / DSMB support
• Sentinel dosing oversight and stopping-rule assessment in first-in-human studies
• Medical coding (MedDRA, WHO Drug Dictionary)
• Medical input to data review meetings and protocol amendments

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, optimise resources and make the best possible data-driven decisions.

Protocol optimisation

We also analyse 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.

We can help you with:

• Selection of clinical endpoints
• Protocol - writing and review
• Sample size calculation
• Literature search and review

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 within budget. This way, you can enjoy peace of mind and focus on what you do best.

Worldwide Regulatory Compliance

We are fortunate to work with a global network of some of the most competent local experts to ensure that neither language barriers nor country-specific requirements become an obstacle.

Our regulatory experts continuously monitor country-specific regulatory and ethics requirements and liaise with all relevant stakeholders to ensure that submissions remain fully compliant.

Meet the Regulatory Authorities

We support and accompany you during meetings with international, national and regional regulatory authorities (FDA, EMA, MHRA, AIFA, AEMPS, Swissmedic, etc.) in order to discuss applications (CTA/IND), protocols or data obtained from previously conducted trials.

Some of our services include:

• Gap analysis & IMPD/IB writing
• CMC support for Drug Substances (NCEs, biologics, biosimilars, etc.) and Drug Products
• Pre-clinical protocol & report review (analytical methods, impurity characterisation)
• Regulatory Authority meetings (EMA, FDA, country-specific)
• Applications:
  • Clinical Trial Authorisations (CTA/IND)
  • Orphan Medicinal Product Designation

Clinical project management & CTMS

A team of clinical trial experts dedicated to your trial, supported by modern, user-friendly and secure technology, will ensure that all stakeholders are kept up to date with any relevant event in a transparent and timely manner.

A team of clinical trial experts dedicated to your trial, supported by modern, user-friendly and secure technology, will ensure that all stakeholders are kept up to date with any relevant event in a transparent and timely manner.

Your dedicated Project Manager acts as a liaison between clinical operations, administration and logistics, coordinating all participants and activities throughout the study. They centralise and harmonise all relevant information, allowing you to easily access and analyse data in real time.

As your main point of contact throughout the duration of all contracted services, your Project Manager provides regular updates and facilitates access to our Clinical Trial Management System (CTMS), enabling real-time visibility of study progress and key milestones.

Investigational site management: Find the right site and the right patient

Since we also conduct hundreds of studies at our own clinical trials unit, we are cognisant of the potential challenges investigators may encounter, enabling us to anticipate and implement the necessary preventive actions.

Having managed all types of single-site and multicentre international studies across a broad range of therapeutic areas, we have qualified some of the world's leading specialised medical centres, Key Opinion Leaders (KOLs) and patient associations.

We build long-standing and trusted relationships with site staff and develop a deep understanding of the challenges involved in order to minimise risk.

Some of the parameters we assess prior to qualifying an investigational site include:

• GCP compliance
• Patient recruitment capacity
• Degree of specialisation in the relevant therapeutic indication
• Duly qualified staff
• Operational and logistical capacity
• Availability of dedicated equipment and materials
• Local regulatory and ethics expertise

Site administration and operational support

We can also manage all relevant administrative, logistical and general site support activities on your behalf, allowing you to focus on the progress of the study itself. From project initiation through to study close-out, each investigational site benefits from a dedicated team and support line, providing immediate assistance from the relevant administrative and technical personnel involved in the study.

• Authorisations, contracts and agreements
• Human resources management
• Customised study training
• Hospital overhead cost negotiations
• Third-party payments
• Logistics and supply chain management
• Laboratory, pharmacy, imaging, EEG, ECG and specialised equipment management
• Sample management and shipment
• Investigational Product (IP) tracking and storage

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.

• 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.

• 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.

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.

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.

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.

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.

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:

• The Eurofins Group Anti-Bribery Policy
• The Eurofins Group Modern Slavery Statement
• The Eurofins Group Fair Competition Policy
• The Eurofins Group Equal Opportunities and Fair Employment Policy
• The Eurofins Group Health and Safety Policy
• The Eurofins Group Privacy Policy
• The Eurofins Group Policy on Ethical Behaviour at Laboratories (with Examples of Prohibited Behaviour and Information about Whistleblowing Channels)
• The Eurofins Group Policy on Ethical Behaviour during Audits, Inspections and other Offsite Operations
• The Eurofins Group Supplier 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.

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