Logistics and full project management: a key for success in early clinical drug development
By Dr. Yves Donazzolo, Eurofins Optimed, France
Reliable and accurate conclusions of an early clinical trial are key in an effective "go/no go" decision process from First-into-Human to Proof-of-Concept in healthy subjects or patients.
Since 1990, with 100 beds dedicated to clinical pharmacology in healthy volunteers and patients and a large area for ambulatory trials, Eurofins Optimed - one of the European leaders in Early Development - has been offering a tailored, high-quality service to the pharmaceutical industry and biotechnology companies.
Indeed, Eurofins Optimed accompanies Sponsors to set up and conduct their clinical trials in many countries, identifying and coordinating all the collaborators of the clinical trial. The Project Management Team at Eurofins Optimed provides full and adapted services covering Western and Eastern Europe, including:
- Protocol development, regulatory activities (Ethics Committee and Central Authorities approvals)
- Identification & selection of investigator sites, site monitoring
- Therapeutic unit management: import, control, packaging, labelling, preparation, accountability, destruction
- Data management, eCRF solution based on Oracle Clinical secured database (accessible worldwide)
- Logistics: hospital and investigator agreements, laboratory services, human resources, sample shipment
A team with more than 20 years of experience in various therapeutic fields (Oncology, Neurology, Rheumatology, Cardiology, Dermatology) makes the difference in the organisation of an early clinical trial.
The Sponsor can request only the services needed for a great and cost-effective partnership experience.
The experience of Eurofins Optimed and its clients-driven approach, which has been awarded ISO 9001:2008 for its services, ensures Sponsors with high-level and successfully conducted clinical trials.
Contact: YvesDonazzolo@eurofins.com or clinicaltrials@eurofins.com
