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

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
Internal and external audits

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

Consultation

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