Clinical Study Conduct

Study Types

MTZ Clinical Research, at own Clinical Research Site, provides a wide range of services

Phase studies I in healthy volunteers

Phase studies I in renal and hepatic impaired patients

Phase studies I – IIa in different indications in patients

Studies of Biosimilarity in healthy volunteers and patients

Studies of Bioequivalence, Bioavailability and drug metabolism in healthy volunteers and patients

Pharmacokinetics/Pharmacodynamics study

Phase III – as a highly specialized Clinical Research site

Vasoconstrictor assay in skin (VCA)

Medical experiments Proof-of-Concept

Therapeutical Area

Bioavailability/Bioequivalence in healthy volunteers and patients
Biosimilarity in healthy volunteers and patients
Cardiology
Dermatology
Diabetology
Gynecology

Hematology
Oncology
Neurology
Pulmonology
Rheumatology

Study population

MTZ possesses a database of 10 000 healthy volunteers and patients all registered in GIODO

Asthma / chronic obstructive pulmonary disease (COPD)
Atopic dermatitis
Cancer (large intestine, stomach, pancreas, liver)
Diabetology
Healthy male and female volunteers
Hypertension
Leukemia, Hodgkin’s disease, lymphoma, multiple myeloma
Menopausal women
Psoriasis (skin and nails)
Smokers and non-smokers
Special populations: hepatic and renal impaired, elderly, obese
Uterine myoma, endometriosis

MTZ Clinical Research

MTZ Clinical Research Centre activities

MTZ provides the following services:

Preparation of a comprehensive documentation from protocol design to the final report

Clinical trial regulatory and bioethical approval

Clinical study management

Study monitoring

Data management and biostatistical analysis

Audits of Clinical Research Sites

Trainins in SCP rules (Transcelerate accreditation)

Clinical analyzes provided for early phase studies at own certified Medical Analysis Laboratory

Clinical Site laboratory

Medical Analysis Laboratory

takes part in the external quality control system, which is led by:

  • The Centre for Research Quality in Laboratory Diagnostics in Łódź
  • International quality assessment – RIQAS,  LabQuality

 

Laboratory conducts the following analysis:

  • Hematological tests
  • Biochemistry tests
  • Electrolytes evaluation
  • Urinalysis

Laboratory of biological sample processing takes care of biological samples preparation according of study protocol

 

A full list of lab tests performed in our laboratory can be downloaded here

MTZ Clinical Research

Consultations and trainings

We offer consulting services in the field of:

Planning the scope of preclinical studies

Analyzing the results of performed preclinical studies

Preparing strategies and study outlines

Defining assumptions of main study

Evaluating the documentation with regard to its usefulness in clinical trial submissions

We offer trainings in:

Good Clinical Practice for clinical research sites