Comprehensive services

A modern research unit offering a wide range of services,
from document preparation to the final report

Offer

MTZ Clinical Research provides a wide range of services:

  • Obtaining legal-administrative (URPL) and bioethical (KBE) approvals
  • Conducting clinical trials at own Clinical Research Center
  • Clinical study management
  • Preparation of study medical documentation (synopsis, protocol, ICF, CRF and final report, using calculations in SAS 9.4 and Phoenix WinNonlin v. 8.1)
  • Medical analyses at the MTZ Certified Medical Research Laboratory
  • Biological samples processing
  • Data management
  • Biostatistical analysis
  • Audits of research centers
  • Training on the principles of good clinical practice (GCP) (accreditation of GCPpl and Transcelerate Biopharma Inc.)
  • Study monitoring

Therapeutical areas

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

Hematology
Oncology
Neurology
Pulmonology
Rheumatology

Healthy participants and patients

MTZ possesses a database of 12 000 healthy participants and patients

  • Asthma / chronic obstructive pulmonary disease (COPD)
  • Atopic dermatitis
  • Cancer (large intestine, stomach, pancreas, liver)
  • Diabetology
  • Healthy male and female participants
  • 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

Study types

  • Phase I studies in healthy participants
  • Phase I studies in renal and hepatic impaired patients
  • Phase I-IIa studies in different indications in patients
  • Studies of biosimilarity in healthy participants and patients
  • Studies of bioequivalence, bioavailability and drug metabolism in healthy participants and patients
  • Pharmacokinetics/Pharmacodynamics study
  • Phase III – as a highly specialized Clinical Research site
  • Vasoconstrictor assay in skin (VCA)
  • Medical experiments Proof-of-Concept
Clinical Site laboratory

Medical and biological laboratory

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

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

 

Laboratory conducts the following analysis:

  • Hematology tests
  • Biochemistry tests
  • Electrolyte evaluation
  • Urinalysis

Biological sample processing laboratory takes care of biological samples preparation according to study protocol

 

Laboratory tests performed – here

MTZ Clinical Research

Consulting and trainings

  • Analyzing the results of performed preclinical studies
  • Defining assumptions of main study
  • Evaluating the documentation with regard to its usefulness in clinical trial submissions
  • GCP for clinical research sites (accreditation of GCPpl and Transcelerate Biopharma Inc.)
  • Planning the scope of preclinical studies
  • Preparing strategies and study outlines