CRFF-Solutions History

CRFF-Solutions is a cooperation of companies active in clinical research, covering all areas of clinical drug development. Emerging from classical phase I units, the cooperation extended phase I activities from male and female healthy young and elderly volunteers to target (e.g. oncology patients) or special populations. The latter serve as pharmacological models to investigate the impact of imaired organ function on the absorption, distributins, metabolization and excretion of investigational compounds.

CRFF-Solutions gained also experience in a variety of interaction trials also with PK/PD correlation.

Emerging from highly standardized early clinical drug develoment, CRFF-Solutions transferred its concept of controlled boundary conditions for clinical studies to hospital based clinical sites, specialized in different therapeutic areas, for pahse II and phase III clinical trials.

Cor Activities are:

Phase I clinical trials in male and female  young and elderly healthy subjects as well  as in special patient populations (e.g. oncology patients or renal or hepatic impaired patients)

Interaction trials including pharmacocintec parameters and surrogate parameters for pharmacodynamic

Proof of concept trials in the target population (phase IIa)

Phase I pahrmacodynamic trials (e.g. TQT trials according to FDA standards in healthy subjects and risk populations (e.g. post-infarction patients)

Clinical trial site selection and management for multi-center pahse IIb and III trials

First experience in phasless drug development by combining phase I and IIa in one protocol within less than six month

Rescue site provider in case of recruitment problems in phase II and III multi-center trials