STAFF
In the scientific section, our team includes 8 PhDs, 2 pharmacists and 2 veterinarians, 2 chemists,and 4 study engineers. Two of our scientists are additionally graduated in Biostatistics. Behind the scenes,30 technicians, each having a diploma in Applied Biology or Biochemistry, assure an efficient and smooth-running laboratory routine for the sake of the benefit of our clients.
Our bioanalysis unit gives the required analytical support, avoiding unnecessary handling and shipments of chemical or biological samples.
CERB has evolved to a global player, with an international net, of scientifically qualified associates, supporting us in breaking down language and cultural barriers.
All our studies are conducted to comply with world-wide regulatory requirements.
A skilled and effective administration will give you a warm welcome to CERB, either face to face or by means of electronically communication.
Each member in this global team works in harmony to provide the service you demand with the quality standards you expect.
ANIMAL FACILITIES
The animal accommodation includes 4 independent units for separate housing of different species (including non-human primates) in an area of 5 000 square meters. Elaborated and state-of-the-art protection systems and rigorous preventive maintenance and emergency procedures guarantee security from unforeseen external or internal hazards.
GLP
About 80% of pharmacology and toxicology studies are performed in compliance with Good Laboratory Practice (GLP) regulations. The Quality Assurance (QA) Program as put into force by a Quality Engineer and all experimental procedures are defined by continuously updated Standard Operating Procedures. The QAU management reports directly to CERB’s Managing Director. This procedure is fully implemented, in order to guarantee the highest level of regulatory compliance, integrity, reliability and reproducibility of experimental data capture and processing.
We are subject to regular inspections by AFSSAPS, GIPC and AFSSA and were inspected by the FDA in 2006.
BIOSTATISTICS
Highly important prerequisites to the generation of conclusive study results are careful biostatistical considerations of experimental design at the outset. Consequently we take the utmost care in study planning, taking into account the variability of measured parameters or or the total of experimental units (i.e. animals or isolated organ preparations) to be utilized. These prerequisites, together with appropriate statistical tests, guarantee a critical evaluation of absence or presence of examined effects. Statistical data analysis is fully computerized using validated and CFR 21 Part 11 compliant software.
CONFIDENTIALITY
Confidentiality and security of information from test item reception to data processing, analysis and storage are fundamental principles ruling client matters. All testing materials received and information communicated or generated in the context of contracts performed by CERB are the sole property of the client. CERB will not make any use of such information without the clients prior written authorization. Individual secrecy agreements reflect the framework of information security.
ETHICAL COMMITTEE
Study protocols are reviewed by our internal ethics committee to minimize the use of experimental animals and to avoid animal suffering during the experimental procedures we intend to adopt. The principle of the three Rs (‘Replace, Reduce, Refine’) are in the focus of our considerations.
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*All information courtesy of CERB. Any information listed above is not a reflection of Pharmafacts' opinion.