| Good planning gives good cost control |
| When a drug has passed the preclinical development stages, including animal
tests, it is ready for human testing. This takes place in three stages which
can lead to the drug being registered and ready for marketing. |
| |
| PhaseOneTrials specializes in early clinical studies of new drugs in early
phase I and phase II trials, from “First-in-Man” to “Proof-of-Concept”. |
| |
| These two initial clinical stages are critical to the success of a drug.
They must thus be designed with great care in order to deliver as much information
as possible on the drug. Many new drug candidates can and should fail during
early clinical development phases as a consequence of negative side effects
or lack of effect. Proper planning can prevent a drug from failing in later
trial phases, and thereby ensure the beginning of a profitable development
process. |
| |
Therapeutic expertise
PhaseOneTrials has developed special knowledge and expertise in the following
areas: |
- Metabolic disorders such as diabetes and osteoporosis
- Diseases of the brain and nervous system
- Inflammatory diseases such as arthritis
- Skin diseases such as psoriasis
|
Rare diseases and children’s diseases
PhaseOneTrials is highly skilled and experienced in the treatment of children
with rare inherited diseases. We are accustomed to transporting, housing,
examining and treating children from other countries. And we are accustomed
to the logistic demands of working closely with specialists and laboratories
at both Hvidovre University Hospital and other university hospitals. |
| |
First-in-Man studies
One area of PhaseOneTrials expertise is highly advanced studies with new
drugs, including outstanding competencies in performing First-in-Man studies
with new biological drugs, as well as with classic pharmaceutical drugs.
|
| |
| Current international regulations require that studies of new biological
drugs be carried out in hospital environments with unhindered access to
acute emergency medical care and intensive care units. |
|  |
 |
