Early Development - Phase I and IIa
Recognized clinical expertise and inclusive service
Our clinical development activity is part of the integrated approach of Eurofins Pharma Services. Our costumers find in Eurofins ׀ Optimed a reliable and internationally recognized partner to conduct Phase I and Phase IIa clinical trials. We have a broad and longstanding experience working with pharmaceutical, biotech and agro-food companies in managing and conducting their clinical studies. We recognized the need of our clients not to get only data from their studies but to have also a full service. With Eurofins ׀ Optimed, we are going beyond and are building trust through consultancy, expertise, customisation and quality. The fidelity of our clients reflects their benefit in choosing Eurofins ׀ Optimed for their clinical trials.
Clinical study management under highest ethical and scientific standards
In our clinical Phase I and IIa units in Grenoble (F) and Lyon (F) we have a capacity of over 80 high intensive care beds to provide a broad range of clinical services. Our priority is the safety of the individuals in our care respecting our ethical and scientific standards. Eurofins ׀ Optimed runs one of the few French and European Phase I units located within a major hospital that can provide emergency medical services if required. Our clients wants us to run their Phase I and IIa studies as they are attracted by our distinctive approach. We offer one of the safest environments combined with our outstanding scientific and logistical expertise of a big group as Eurofins. We have the capacity and flexibility to put in place and conduct your study rapidly as we have one of the most efficient recruitment systems in industry. Our activities are clinical pharmacology, monitoring, data management, statistics and medical writing including as well:
- Entry Into Man
- Absolute, Relative Bioavailability
- Bioequivalence
- Interactions,
- PK/PD
- Metabolism,
- Food / Gender /Age effect...
Clinical data preparation up to dossier submission
Eurofins Pharma Services offers not only complementary services to the phase I & IIa studies carried out in our clinical units, but also undertake the entire implementation of Phase IIb to phase IV studies, surveys, data management and medical marketing studies. We have all major technical activities for clinical studies in place: monitoring, data management, statistics and medical writing. We formed over the years an experienced and effective team which can crunch up even the hardest cases. The services include the following activities:
- Writing of data validation plan
- Database design & administration
- Data entry with double & independent keyboarding
- Data Validation
- Coding (MedDRA®, Who-Drug…)
- Blind Review
- Database freezing
- Database transfer
With our clinical facilities for Phase I and IIa studies we can help you to achieve this important milestone in drug development. Beyond this we can speed up the full development phase with our outstanding supporting services, such as clinical trial logistics, bioanalysis, central laboratory analysis, genomic analysis, etc…. At Eurofins Pharma Services, your compound and project is in the best hands.
For further information please contact us: pharma@eurofins.com