SERVICE

Phase I-IV Clinical trials

Clinical and Diagnostics Center of National University of Pharmacy (NPhU CDC) offers the services for Phase I-IV clinical trials.

Our professional staff with many years of experience is ready and in time will cope with all assigned tasks.

Training on GCP

Our establishment provides training on GCP together with the State Expert Center of Ministry of Health of Ukraine and then issues the certificates of the approved pattern.

The next training will be held on 16 December 2017. For more accurate information, please contact us.


Study protocol development

Clinical and Diagnostics Center of National University of Pharmacy offers services for study protocol designing, as well as study associated documentation development.

Our experienced professional staff is always ready to help you and in time will cope with all assigned tasks.

BIOEQUIVALENCE STUDIES

Clinical and Diagnostics Center of National University of Pharmacy (CDC NPhU) offers services for bioequivalence studies.

Clinical and Diagnostics Center of National University of Pharmacy conducts high-grade bioequivalence studies. In our center, it is also possible to consult on specific issues, or have a complete examination. Our experienced professional staff is always ready to help you and in time will cope with all assigned tasks. Contact us at your convenience - contacts.

Statistical research

Clinical and Diagnostics Center of National University of Pharmacy (NPhU CDC) offers services in data processing and analysis of clinical and pre-clinical studies for pharmaceutical plants, pharmaceutical companies and CRO.

In the work of our center there were implemented the approaches to clinical data management, appropriate biostatistical support of the trial project from the moment of its initiation till its completion including the process of the results submission to the regulatory authorities.

CDC NPhU staff has practical experience in the realization of biostatistical design projects of clinical trials, further assistance and data analysis. Our work is based on the principles of process-oriented project management that enables to optimize and ensure its effective implementation at all stages of clinical research.

Our core services in biostatistics and data management include the following:
Statistical consulting:

The discussion of the study design from the perspective of statistical methods for its realization.

The sample size and power calculation.

  • The statistical analysis planning.
  • Statistical modeling.
  • Statistical analysis.
  • Compilation of interim and final reports.
  • Periodic reports on the study regarding its current state.
  • Statistical reports.

Data Management:

  • The creation and development of trial database.
  • Data entry and quality control.
  • Double data entry.
  • Verification and validation of data.
  • Querying about discrepancies (queries).

The provided services for biostatistician project management of clinical trials and data management gives you the ability to:

  • facilitate and automate the process of managing and interpreting the data of clinical studies;
  • improve and formalize the process of decision-making in the process of drug development;
  • compare/merge data from clinical trials with data from available data in the literature on the basis of mathematical modeling and theory of experiments.

If it is needed and in case of prior discussion and agreement additional services on biostatistics and trial data management can be performed by NPhU CDC.