| |
|
|
|
|
- Safety and pharmacokinetic studies |
|
- Bioequivalence |
|
(single and multiple dose) |
|
- Tolerability studies |
|
- Special population studies |
|
(renal, hepatic insufficiency, old age, menopausal |
|
women, diabetic, thyroid, endocrine etc.) |
|
PRS is specialized in performing high quality, well-controlled clinical pharmacology studies, providing a clinical pharmacology consultancy services for compiling the necessary documents, Protocols, Study Reports. |
|
- Protocol design |
|
- Case Report Form design |
|
- Statistics |
|
- Expert Report writing |
|
- Investigator's Brochure writing |
|
- Patient studies (Clinical Studies) |
|
- Reprezentation before national authority |
|
CPU and PRS are used to plan a study (Protocol, CRF and all necessary documentation), submit for approval and then help performing the study. Clinical and Statistical Report writing is included.
CPU and PRS often used the facilities of ACC Laboratories, Germany, this is an Analytical Laboratory specializing in clinical pharmacology.
|