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)

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 volunteers and patients
Biosimilarity in healthy volunteers and patients
Cardiology
Dermatology
Diabetology
Gynecology

Hematology
Oncology
Neurology
Pulmonology
Rheumatology

Healthy volunteers and patients

MTZ possesses a database of 10 000 healthy volunteers and patients

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

Study types

 

 

Phase I studies in healthy volunteers

Phase I studies in renal and hepatic impaired patients

Phase I-IIa studies 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

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