Protocol Developement & Regulatory submissions

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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, 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
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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 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.

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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

Our laboratory

Eurofins Optimed SAS

1, rue des Essarts, 38610 Gières, France

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Supporting your clinical trials

Looking for a trusted partner to support your clinical trials? Let’s discuss how we can support your development programme.

Contact us 

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