Clinical Studies
We provide to our external partners, bioequivalence studies, following the authorities’ regulations, at competitive prices.
The bioequivalence clinical studies center is organized as follows: the clinical unit, the bioanalytical laboratory, pharmacokinetics, and statistics.
BIOEQUIVALENCE
Clinical Research
We own an independent clinical unit, with a well-prepared medical staff and extensive expertise, making sure that the clinical studies are led in a very well-controlled environment, complying with the regulations of protection and security of the subjects.
The Clinical Unit has a capacity of 26 beds (5 saloons, each with its bathroom), an information room, medical cabinets, an emergency room, rooms with samples, meal room / recreation, all of them being equipped according to legislation requirements.
Vitema Pharmaceuticals has started a partnership with AI Clinical Research, which operates within our Bioanalytical Laboratory. This facility is equipped with the latest medical equipment. To observe the flows of materials and biological samples, we have designated areas for primary processing, regular processing, analysis, and sample storage.
- AI Clinical Research is a full-service company in the area of clinical research based on the newest technology with national coverage and providing clinical trial-related services to pharmaceutical, medical devices, and biotechnology companies. AI Clinical Research is part of a global local CROs network that allows AI Clinical Research to provide clinical trial services in Europe, the US, Canada, the Middle East, Africa, and Southeast Asia.
- AI Clinical Research covers phase I and bioequivalence studies, as well as clinical phase II-III trials.
- AI Clinical Research services:
- Clinical Monitoring
- Project Management
- Regulatory Affairs
- Start-up activities
- Feasibility studies
- Site Management including budget and contracts
- Patient Management
- Data Management
- Statistics
- CSR
- Medical monitor
- Pharmacovigilance
- Medical writing
- Site contracts, budget development, and negotiations.
- AI Clinical Research staff has extensive phase I-III clinical experience in:
- Neurology (multiple screlosis, Parkinson)
- Oncoloy (breast cancer, lung cancer, testicular cancer)
- Cardiology (heart failure, myocardial infarction, cardiomyopathy)
- Pneumology (asthma, COPD)
- Nephrology (renal anemia, renal failure)
- Immunology
- Bowel Disease (Chron Disease)
- Thrombo-embolic Events
- Dermatology (Psoriasis)
- SARS-COV
- Rare Disease (Tuberous Sclerosis)
- Psychiatry (Schizophrenia)
- Ophthalmology (macular edema)
- Diabetes
- Gynecology (endometriosis)
- Urology (Nicturia)
- Rheumatology (rheumatoid arthritis)
- Endocrinology (hypogonadism)
Pharmacokinetic and statistical evaluation of the results is carried out by experts, using globally approved software.
Our team provides extended pharmacokinetic and statistical support in clinical trials.
Private label manufacturing
Having a manufacturing facility for therapeutic oral solid medicines with a current anual of 3.5 billion tablets and capsules per year makes us one of Europe’s largest manufacturing GMP pharmaceutical facilities.
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