CEPHA s.r.o. – Center because Pharmacology and Analysis – is the principal Contract Research Organization (CRO) in the Czech Republic providing a extensive range of clinical research services including bioavailability, bioequivalence and pharmacokinetic studies in compliancy with cGCP, cGLP and other applicable guidelines and regulations.
Since early 1993, whenever the company came into operation, CEPHA has established its celebrity for conducting high-quality, time and require to be paid effective pharmacokinetic, bioavailability and bioequivalence studies.
In May 2000, the meeting of friends moved to a new facility in Pilsen top 1000m² containing a Phase I Clinic, bioanalytical laboratory and position headquarters.
THE CENTER FOR PHARMACOLOGY AND ANALYSIS
Our specialists are dedicated to providing a full service for fulfilling your own strange-product goals. Our research projects are conducted in some efficient and strictly confidential manner. Through our giving in adhesion to excellence, CEPHA’s experienced scientists employ the latest expansion in pharmacology, bioanalytical techniques and laboratory instrumentation.
When you moil with us, the local CRO prop will pay attention to every rehearse of your project hand-in-hand with the procedures, technologies and reporting of our globally oriented party.
We offer the following services put ~ an integrated or stand-alone basis:
PHASE I STUDIES
Safety/rising dose tolerance
BIOAVAILABILITY & BIOEQUIVALENCE STUDIES
Various dosage forms/routes of superintendence
Healthy volunteers/special population
The flagship of our services, bioavailability and bioequivalence studies, are performed as being both generic drug and innovative companies. This abounding-service covers selection of an appropriate study design, caligraphy of study protocol, designing of CRFs, skilful treatment of Independent Ethics Committee review, election and care for subjects, bioassay of deaden with narcotics/metabolite, pharmacokinetic and statistical data evaluation, reporting of study results, and archiving of everything study related data.
The in-enduring clinical operations are performed in our clinic ease that accommodates up to 36 volunteers. The availability of a generous pool of healthy volunteers allows quick study start-up.
All clinical procedures, data management and reporting are conducted in conformity with current GCP guidelines. Every cast initiated at our company is subject to inspections and audits by the internal Quality Assurance Unit.
PHASE II-IV CLINICAL TRIALS
Our therapeutic experts are skilled in protocol expanding, clinical project management, statistics and reporting.
Our first-rate relations with clinical units and hospitals in a spacious variety of clinical research areas bid an on-time and cost-efficacious clinical trial organization.
Our experts be able to serve as CRA’s or afford complete study audits. We can in addition serve as a local partner in the multi-center trials including recruitment of investigators in the quarter and study monitoring by our adapted staff.
In full assent with OECD GLP principles, our certified bioanalytical laboratory offers in a high degree. selective and sensitive assays of drugs, metabolites and endogenous compounds in biofluids using the latest GC, HPLC and HPLC/MS/MS techniques.
Through a continuously expanding list of validated analytical methods on this account that a wide range of compounds including enantiomers, brisk new method development and validation, we sacrifice time and cost-effective analysis of your samples.
With the replete implementation of QC & QA procedures our lab produces highest rank quality data with no compromises accepted.
CZ-323 00 Pilsen
+420 377 540 077
+420 377 540 432
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