Clinical Study Conduct

Study Types

MTZ Clinical Research, at own Clinical Research Site, provides a wide range of services in early clinical research:

Studies of Phase I in healthy volunteers

Studies of Phase I in renal and hepatic impaired patients

Studies of Phase 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 (database with 10000 healthy volunteers and patients)

Psoriasis (skin and nails)

Atopic dermatitis

Cancer (large intestine, stomach, pancreas, liver)

Leukemia, Hodgkin’s disease, lymphoma, multiple myeloma

Hypertension

Asthma / chronic obstructive pulmonary disease (COPD)

Diabetology

Uterine myoma, endometriosis

Healthy male and female volunteers

Special populations: hepatic and renal impaired, elderly, obese

Smokers and non-smokers

MTZ Clinical Research

CRO 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

Trainings in SCP rules (Transcelerate accreditation)

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

Clinical Site laboratory

Laboratory of Medical Analysis

takes part in the external quality control system, which is led by The Centre for Research Quality in Laboratory Diagnostics in Łódź and additionally by external unit LabQuality

Laboratory conducts the following analysis: Hematological tests Biochemistry tests Electrolytes evaluation Urinalysis

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