Early Development - Phase I and IIa
Recognized clinical expertise and inclusive services
Our clinical development activity is part of the integrated approach of Eurofins' pharma services. Our customers find in Eurofins Optimed a reliable partner to conduct Phase I and Phase IIa clinical trials.
We have a broad and longstanding experience working with pharmaceutical, biotechnological 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, customization and quality. Certified ISO 9001 : 2000, we are committed to ensuring volunteers’ safety, data accuracy and high quality services.
Phase I and IIa study under highest standards
In order to obtain the best quality for your clinical studies, Eurofins Optimed has two different Clinical Pharmacology Units:
- A 60-bed ClinPharm Unit in Grenoble, with 12 intensive monitoring beds
- A 32-bed hospital-based ClinPharm Unit within the Lyon-Sud Hospital
These units are run by an efficient and experienced team of clinical research professionals: physicians, pharmacists, nurses, clinical trial technicians. Eurofins Optimed has efficient recruitment capacities, thanks to a database of over 20,000 rigorously selected healthy volunteers and specific populations.
With 20 years of experience in Early Clinical Development, Eurofins Optimed can undertake many type of studies:
- First Into Human studies: single and multiple ascending dose, Food / Gender /Age effect...
- Pharmacokinetic studies: drug-drug interactions, bioavailability, bioequivalence, food/alcohol interaction …
- Pharmacodynamic studies: QT/QTc studies …
Thanks to Eurofins Optimed’s up-to-date equipment in various fields of research, we ensure the success of the relevance of your study:
- Neurology (Sleep lab, EEG, Psychometric Tests…)
- Cardiovascular (ECG monitoring, Telemetry, Exercise test, …)
- Respiratory (Sputum collection, Spirometry, …)
- Hematology (Platelet aggregation, …)
- Various biological markers
- …
Clinical Data Services and Project Management
Eurofins Optimed offers not only complementary services to the phase I & IIa studies carried out in its clinical units, but also undertakes the entire management of Phase IIb to phase IV studies, epidemiological surveys, and post marketing studies. Eurofins Optimed ensures suitable management of your data, from study initiation of your project to the final report. These services, performed by an experienced team of Clinical Research Associates, Data Managers, Statisticians and Medical Writers, include :
- Global project management
- Monitoring
- Medical writing (from medical design to study report)
- Data Management
- Statistics
With Eurofins Optimed, 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, your compound and project are in the best hands.
For further information please contact us: pharma@eurofins.com
