Centre for Drug Evaluation
The Centre for Drug Evaluation (CDE) is a research unit authorized by the Romanian Ministry of Health which develops clinical trials with no therapeutic benefit (phase I studies and bioequivalence studies). Our company’s CDE was inaugurated in 2006 and is the first Center of its kind in Moldavia and one of the largest in Romania.
Within an integrated structure the CDE provides comprehensive clinical services at a high scientific level, starting from designing and getting the study authorizations to the preparation of the final reports, geared toward meeting the needs of our clients. So far, the Center for Drug Evaluation has developed over 100 clinical bioquivalence and phase I trials for our Company’s own products and also for external customers in Europe (France, Greece, Cyprus, the Netherlands, Norway) and Canada.
Studies are required for the authorization of medicines and for ensuring the scientific data required to confirm the efficacy and safety in administration on human subjects. Thus, the pharmaceutical equivalence between a generic drug and a reference drug(an innovative one) is tested and demonstrated based on the pharmacokinetic and pharmacodynamic analysis results.
Benefits
The CDE has a clinical unit, an analytical unit and a secondary packaging line for clinical investigation drugs.
The Clinical Unit
The Clinical unit is equipped with 32 beds arranged in four wards. The wards are equipped with monitoring system with cameras. The clinical unit has also medical offices equipped with medical devices for clinical examination and emergency equipment necessary for studies under maximum safety conditions, a dining room and other useful spaces (waiting room, changing rooms, toilets, kitchen, recreation spaces for volunteers, etc.)
The Bioanalytical Unit
The Bioclinical Unit has several laboratories (physics-chemistry determinations, biological samples processing, instrumental determinations) as well as a space dedicated to preserving biological samples in freezers in a controlled temperature with a restricted access. The GLP certified bioanalytical laboratory performs determinations of active substances and metabolites from biological matrices by high performance liquid chromatography, using various detection types: UV, fluorescence and mass spectrometry. All the laboratories are fully equipped with last generation equipment. For the safety of the biological samples, temperature is permanently controlled in the freezers and laboratories with an alarm system in case it exceedes the prescribed limits.
The secondary packaging line for clinical investigation medicines
The secondary packaging line for the clinical investigation medicines has a class D controlled area, where the single dose packaging of drugs is carried out according to the international GMP standards
Staff
The Center for Drug Evaluation has an interdisciplinary team of specialists in the field of medicine, clinical pharmacology, chemistry, biochemistry, and biology with high professional credentials, certified in research (researchers and scientists) and having completed PhD degrees in medicine and chemistry.
Our specialists are permanently trained in the Quality Assurance field, as the studies require knowledge and compliance with the specific regulations stipulated by the international law.
The compliance with the scientific and quality standards for the design, management, conduct, recording and reporting of clinical trials carried out by the CDE, according to the national and international regulatory documents in the field (ICH, EMA, FDA, Health Canada), is monitored by our own Quality Assurance Department, whose members collaborate with and are affiliated to the British Association for Research Quality Assurance (BARQA) from the United Kingdom.
Authorisations
Good Laboratory Practice Certificate
