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CAPABILITIES
- Bioequivalence/ Bioavailability studies
- First-in-Man Studies: single or multiple dose, ascending dose, etc.
- Pharmacokinetic Studies
- Pharmacodynamic Studies
- Drug-Drug and Drug/Food Interaction Studies
- Cardiac Safety Studies
- Specialist investigations in Renal and Hepatic impaired subjects
- Extensive volunteer database; healthy males and females, pre- and postmenopausal women, elderlies, diabetes mellitus patients, patients with mild to moderate hypertension, patients with restless leg syndrome, patients with mild to moderate asthma, patients with renal or hepatic impairment, etc.
- Proof of Concept studies in patient groups, e.g. asthma, diabetes, psoriasis, allergy, rheumatoid arthritis, postmenopausal disorders, gastric ulcer, pain, inflammation
- Genotyping and phenotyped populations for P-450 Iso-enzymes
- Different routes of administration; oral, intravenous, intramuscular, buccal, transdermal, intranasal, rectal, inhalation
- Nuclear Pharmacology studies
- EEG brain mapping studies
- Imaging technologies – PET and NMR
- Integrated support services;
- Clinical Chemistry and Hematology
- Bioanalytical Analysis
- PK/PD Analysis
- Pharmaceutical Analysis
- CTM Manufacturing and Packaging
- Clinical Data Management
- Biostatistical Analysis
- Medical Writing
- Regulatory Submissions; FDA, EMEA, HPB
- Consultancy in clinical development strategies and protocol design
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services@aaipharma.com
200 Perimeter Park
Morrisville, North Carolina 27560
Tel.: +1.919.481.5700
Wegenerstrasse 13
89231 Neu-Ulm, Germany
Tel: +49.731.9840.0
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Whether you require a First-in-Man trial for your new chemical entity, a Bioavailability / Bioequivalence comparator study, or a Phase IIa Proof-of-Concept trial, AAIPharma offers state-of-the-art facilities for clinical studies on an international basis. In the US, we have expanded our facilities in Research Triangle Park, North Carolina to a new 158 bed clinic. Phase I and early Phase II studies are also performed at our European clinical pharmacology center in Neu-Ulm, Germany, which features a flexible 65 – 90 bed unit including 12 intensive care beds with telemetry for intensive cardiovascular monitoring.
In association with specialist external groups providing centralized ECG evaluation, AAIPharma is also capable of performing the new generation of cardiac safety studies, including thorough QTc-studies. AAIPharma’s in-house regulatory group ensures full compliance with the new European Clinical Trials Directive, for preparation of all pre-study information, including the IMPD.
AAIPharma also maintains an integrated GMP standard manufacturing and packaging facility and the presence of two on-site Qualified Persons (QP’s). Drug supplies for use in your trials can be qualified and released without delay. Our significant capabilities in Bioanalytical and Pharmaceutical Analysis provide the combined benefit of single-site development capability and optimization of project costs and timelines.
We offer
- Experienced research teams of physicians, nurses, technicians, CRAs and data management and biostatisticians professionals
- Rapid subject recruitment
- Healthy volunteers as well as special populations
- A focus on volunteer and patient safety
- Regulatory compliance
- Strict adherence to study protocols
- Established cooperation with local and international investigator networks
- Established cooperation with the University of Ulm (including departments of Endocrinology, Dermatology, Neurology, Dermatology, Nuclear Medicine with NMR, PET and PET/CT)
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