Clinical Study Conduct

Study Types

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

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

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

MTZ Clinical Research Unit services:

  • Audits of Clinical Research Sites
  • Biological samples processing
  • Clinical analysis provided for early phase studies at own certified Medical Analysis Laboratory
  • Clinical study management
  • Clinical trial conduct
  • Clinical trial regulatory and bioethical approval
  • Data management and biostatistical analysis
  • Medical documentation (study synopsis, protocol, Informed Consent Form (ICF), Case Report Form (CRF) and the final report)
  • Study monitoring
  • Trainings in GCP rules (Transcelerate BioPharma Inc. accreditation)
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

Trainings and consultations

  • 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 (Transcelerate BioPharma Inc. accreditation)
  • Planning the scope of preclinical studies
  • Preparing strategies and study outlines