"The CRO symbiosis for your personal success" !
The objectives of Phases II to IV in clinical drug development can only be met if clinical trials are carefully conducted and the results evaluated by an experienced team of highly qualified specialists.
To minimise the risks for subjects in further clinical drug development and to optimise the return of investment, a competent screening of new entities is inevitable. "ICH-Guidelines for Good Clinical Practice" and "Good Laboratory Practice" are our standards and are declared in our SOPs.
The qualifications of our experts have been acquired through many years of work for international pharmaceutical companies, scientific institutions and hospitals.
The management of our projects covers
- evaluation of preclinical data before the first test on humans
- first administration to man, tolerance and dose finding studies including biometrical aspects according to international standards
- pharmacokinetic studies in young and elderly, healthy and sick volunteers
- planning of clinical trials phases II, III, IV including biometrical aspects according to international standards
- studies on efficacy
- bio-availability and bio-equivalence studies
- pharmacodynamic studies
- pharmacoeconomic studies
- studies on interaction
Obtaining the Ethics Committee approval
