-
-
Business Development
enquiries@charite-research.org
Tel: +49 (0)30 450 539 200 -
Recruitment Counts
Our uniquely successful approach to recruitment often allows FTIH studies in patients to be realized using a single-center. This in turn ensures that the need for design compromises is minimized, patient safety is maximized and the most complex pharmacodynamic assessments can be incorporated into the initial study. By doing this we can facilitate the earliest possible exploration of efficacy. While not definitive, such exploration of efficacy can provide valuable information when assessing viability of the product in question and optimal design of subsequent studies.
Example
Stable Schizophrenia
Working in close collaboration with psychiatry partners, more than 25 patients with stable schizophrenia were enrolled into a complex Phase I protocol incorporating assessment of qEEG and event-related potentials. The study was implemented within the CRO Phase I unit, with the patients welfare assured by regular psychiatrist visits and support.
Facts
Rheumatoid arthritis patients
Enrolled 58 RA patients into a FTIH study of a monoclonal antibody, combining SAD & MAD
Multiple sclerosis patients
Enrolled 48 MS patients into a Phase I PK study
HIV patients
Enrolled 32 treatment naive HIV patients into a Phase I/II PK/PD study assessing impact on viral load
Hypertensive subjects
Enrolled 36 Hypertensive subjects into a Phase I/II PK/PD study incorporating arterial stiffness assessments
Healthy Volunteers
Enrolled 220 Healthy Volunteers into a study assessing impact of functional food on immune status
