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Services |


Our specialists are dedicated to providing the following services on an integrated or stand-alone basis:

Phase I Studies

  • first-in-man
  • safety/rising dose tolerance
  • drug-drug interaction studies
  • healthy volunteers/renally & hepatically impaired patiens

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 innovator companies. This full-service covers:

  • selection of 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
  • archiving of 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. The bioassay is performed in our bioanalytical laboratory. Blood chemistry and hematology testing are carried out in certified hospital labs.

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 internal Quality Assurance Unit.

Phase II-IV Clinical Trials

Through our dedicated partners we offer full-service clinical trials planning, management and interpretation under GCP conditions. The services cover:

  • clinical trial planning including statistics
  • study protocol writing
  • designing of CRFs
  • management of Independent Ethics Committee reviews
  • recruitment of investigators
  • study monitoring by experienced CRA personnel
  • data handling and evaluation, record keeping
  • reporting of study results

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 management.

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 of human and animal origin.

Through a continuously growing list of developed 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 latest HPLC and GC instrumentation and full implementation of QC & QA procedures our lab produces top quality data acceptable with no compromise.

Pharmacokinetic and Statistical Data Evaluation

Based on the individual drug concentration data of your pharmacokinetic study our experienced pharmacokineticist and statistitian will provide you with the full interpretation of your data. The services include:

  • determination of all pharmacokinetic parameters
  • individual data listing
  • descriptive statistics of all parameters including SDs and CVs
  • analysis of variance (ANOVA)
  • parametric (non-parametric) 90% confidence interval
  • normality and homogeneity testing
  • power analysis

Using the powerful computerized tools for data evaluation and presentation including the latest version of SPSS Statistical Software we generate the tables, listings and graphs according to your specific needs.

Quality Assurance

In compliance with the GCP principles the quality assurance (QA) program is fully implemented in our company. Reporting to company management, our QA unit routinely performs both system and project-based inspections as well as data and report audits of all company projects.

Our QA specialists ensure the studies are conducted with full adherence to approved study protocol and effective SOPs as well as in compliance with all applicable national and international guidelines and regulations.