CEPHA s.r.o. - Bioavailability and Bioequivalence Studies and Bioanalytical Services

CEPHA s.r.o. - Center for Pharmacology and Analysis - is the leading Contract Research Organization (CRO) in the Czech Republic providing a broad range of clinical research services including bioavailability, bioequivalence and pharmacokinetic studies in compliance with cGCP, cGLP and other applicable guidelines and regulations.

Since early 1993, when the company came into operation, CEPHA has established its reputation for conducting high-quality, time and cost effective pharmacokinetic, bioavailability and bioequivalence studies.

In May 2000, the company moved to a new facility in Pilsen covering 1000m² containing a Phase I Clinic, bioanalytical laboratory and office headquarters.

COMPANY PROFILE

Our specialists are dedicated to providing a complete service for fulfilling your own new-product goals. Our research projects are conducted in an efficient and strictly confidential manner. Through our commitment to excellence, CEPHA's experienced scientists employ the latest development in pharmacology, bioanalytical techniques and laboratory instrumentation.

When you work with us, the local CRO staff will pay attention to every detail of your project hand-in-hand with the procedures, technologies and reporting of our globally oriented company.

We offer the following services on an integrated or stand-alone basis:

PHASE I STUDIES

• First-in-man
• Safety/rising dose tolerance

BIOAVAILABILITY & BIOEQUIVALENCE STUDIES

• Single/multiple doses
• Fasted/fed conditions
• Immediate/modified-release preparations
• Various dosage forms/routes of administration
• Healthy volunteers/special population

The flagship of our services, bioavailability and bioequivalence studies, are performed for both generic drug and innovative companies. This full-service covers selection of an appropriate study design, writing of study protocol, designing of CRFs, management of Independent Ethics Committee review, selection and care for subjects, bioassay of drug/metabolite, pharmacokinetic and statistical data evaluation, reporting of study results, and archiving of all study related data.

The in-patient clinical operations are performed in our clinic facility that accommodates up to 36 volunteers. The availability of a large pool of healthy volunteers allows rapid study start-up.

All clinical procedures, data management and reporting are conducted in accordance with current GCP guidelines. Every project initiated at our company is subject to inspections and audits by the internal Quality Assurance Unit.

PHASE II-IV CLINICAL TRIALS

Our medical experts are skilled in protocol development, clinical project management, statistics and reporting.

Our excellent relations with clinical units and hospitals in a wide variety of clinical research areas offer an on-time and cost-effective clinical trial organization.

Our experts can serve as CRA's or provide complete study audits. We can also serve as a local partner in the multi-center trials including recruitment of investigators in the territory and study monitoring by our qualified staff.

BIOANALYTICAL SERVICES

In full compliance with OECD GLP principles, our certified bioanalytical laboratory offers highly 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 growing list of validated analytical methods for a wide range of compounds including enantiomers, rapid new method development and validation, we offer time and cost-effective analysis of your samples.

With the full implementation of QC & QA procedures our lab produces top quality data with no compromises accepted.