Clinical Research Site With full service Since 2002

MTZ Clinical Research Unit

Company founded in 2002 in Warsaw, Poland, focuses on phase I, early clinical development, bioequivalence and phase III studies.
In January 2021 MTZ Clinical Research joined Pratia. Pratia is a network of clinical research centers in Europe and is part of the Neuca Group.


Services offered:

  • Audits
  • Biological sample processing and storage
  • Clinical study conduct at own clinical research site
  • Consultations
  • Data management
  • Good Clinical Practice (ICH GCP) trainings
  • Medical analysis at own certified medical analysis laboratory or at central lab
  • Medical documentation (from protocol to clinical report, using calculations in SAS 9.4 and Phoenix WinNonlin v. 8.1)
  • Pharmacokinetic (PK) analysis through selected partner laboratories
  • Studies registration

Company values





  • Proven experience (260 conducted studies)
  • High quality services:
    • ISO 9001:2008 (2009-2018)
    • ISO 9001:2015 (obtained in 2018)
    • 1 inspection FDA
    • 2 Polish inspections
  • State-of-the-art Clinical Research Facility with 46 beds
  • Highly trained and experienced study team providing accurate, reliable, and consistent data
  • Respect of trial timelines

Company mission

To ensure the safety of the participants, and ultimately of patients, the conduct of all clinical research trials is performed in strict compliance with the highest international standards.


The network of clinical trials centers in Europe – Pratia,

belonging to the Neuca Group, acquired 100% of MTZ Clinical Research shares

Opening to Russian speaking countries
Modernization and expansion of the clinic area (46 beds)
Closing of the second MTZ Clinical Research Site in Płońsk

due to the COVID 19 pandemic in Poland

Opening of the second MTZ Clinical Research Site in Płońsk
ISO 9001:2015 recertified till 2021 on the basis of successfully passed audit
Polish Routine Regulatory Inspection

(The Office for Registration of  Medicinal Products, Medical Devices and Biocidal Products)

Polish Routine Regulatory Inspection

 (The Office for Registration of  Medicinal Products, Medical Devices and Biocidal Products)

FDA inspection
15th anniversary of MTZ Clinical Research
MTZ Clinical Research becomes the member of SCRS

(Society of Clinical Research Sites)

Dr. Teresa Brodniewicz again elected as the President of Good Clinical Practice Society in Poland
ISO recertified till 2018 on the basis of successfully passed audit
MTZ Clinical Research trial service agreement number 200 signed
Launch of new website
Book „ Clinical Trials”

co-authored by 4 employees of MTZ, edited and published by Dr. Teresa Brodniewicz

ISO certification extended to medical services

in MTZ’s Laboratory of Medical Analysis

Registration of Medical Analysis Laboratory of MTZ Clinical Research
Anna Olak – Popko, MD

becomes Clinical Research Site Deputy Director

Anna Dryja, MD, MBA

becomes Clinical Research Site Director

Małgorzata Drop, MSc

becomes Quality Manager and Quality Management System Representative

Closing of MTZ office in Montreal, Canada
Registration of MTZ US Clinical Research, LLC.

a partner company in Massachusetts, USA

Opening of a Pharmacy Unit

equipped with a laminar flow cabinet

Extension of services to include Oncological Products Studies
ISO 9001:2008 Quality Certificate

obtained from DAS CERTIFICATION Ltd. accredited by UKAS

Creation of independent Quality Assurance Department
Teresa Brodniewicz, MSc, PhD

becomes President

MTZ Clinical Research starts acting as CRO

MTZ takes executive decision to focus on early-stage studies.

Extensive renovation of the Clinical Site
Anna Bereda

becomes Quality Assurance Coordinator

Registration of subject database
First Phase I Study
First Bioavailability Study
MTZ establishes a medical site (NZOZ)

and starts performing clinical trials.

Incorporation of MTZ Clinical Research Sp. z o.o.

Zbigniew Proba, MSc, PhD became President
Teresa Brodniewicz, MSc, PhD became Scientific Affairs and Business Development Director and Vice President


Our core team

All members of the core team have extensive experience in clinical trials conduct either at research institutes, at biopharmaceutical companies or at international CROs in Europe, the US or Canada.

All members of the team are obliged to comply with ICH GCP requirements, EU, Polish legislation and Company’s Standard Operating Procedures (SOPs).

Teresa Brodniewicz MSc, PhD,

Founder and Member of the Board MTZ Clinical Research
Scientific Affairs and BD Director

Biochemist in clinical research for over 20 years. International experience in research and development. Majority owner of MTZ Clinical Research since 2002. President of Polish Society of Good Clinical Practice GCPpl since 2013. Previously Sr. Director at Parexel Int., Warsaw, Poland, 1997–2000. Scientific Director at Blood Fractionation Centre and VP and CSO at Haemacure Corp., both positions in Montreal, Canada 1982–1997. Editor in Chef of the book “Clinical Research” ed. 2015. Expert in the Country Board of Supplements and Nutritions KRSiO since 2015. Author of numerous scientific publications in Nature, Vox Sanguinis, Blood Reviews, and others.

Anna Dryja

Anna Dryja MD, MBA,

Clinical Research Site Director

Specializing in clinical oncology, 20 years in clinical trials (experience gained in pharmaceutical companies, CROs and clinical work), PI in several medical experiments, bioequivalence studies and oncological trials With MTZ since 2012.


Anna Olak-Popko MD,

Clinical Research Site Deputy Director

Specialist in Internal medicine and anesthesiology. Over 15 years experience in clinical trials, bioequivalence and medical experiments, PI in several trials. With MTZ since 2003.

Agata Sosnowska

Agata Sosnowska MSc R.N.,

Clinical Operations Director

Experienced in different areas of clinical research. Coordinator of several Phase I – III and Bioequivalence studies. With MTZ since 2003.

Małgorzata Drop

Małgorzata Drop MSc,

Quality Director

Experience in medicinal product quality for last 16 years. Responsible for maintaining and developing ISO 9001 Quality Assurance System and its recertification at MTZ. Manager of Quality Department at MTZ since 2011.
Quality Director since 2019.


Agnieszka Lewczuk

Agnieszka Lewczuk MSc,

Laboratory Director

Biotechnologist and laboratory diagnostician with over 12 years experience in clinical trials.
Responsible for laboratory procedures management in close cooperation with local and central laboratories as well as in the internal laboratory of MTZ. Performs activities of laboratory diagnostician in the Laboratory of Medical analyses in MTZ. In regular basis takes part in many external trainings in scope of laboratory medicine as well as in clinical trials. With MTZ since 2007.

Marta Zakrzewska

Marta Zakrzewska MSc,

Marketing and Sales Director

Manages business relationships with Clients at MTZ Clinical Research, including assessment of customer needs, meeting quality standards for services, and evaluation of customer satisfaction. Vast knowledge in the area of drug development process. With MTZ since 2006.

Our Physician Team

The investigators employed at MTZ Clinical Research are experienced doctors with specializations in various fields of medicine and experience in conducting clinical trials.
The multidirectional knowledge of our doctors allows the company to conduct research with patients in various therapeutic areas as well as difficult research with healthy participants.

All investigators are obliged to comply with the principles of good clinical practice and the company’s high standards.

Anna Dryja

Anna Dryja MD, MBA,

Clinical Research Site Director

Specializing in clinical oncology, 20 years in clinical trials (experience gained in pharmaceutical companies, CROs and clinical work), PI in several medical experiments, bioequivalence studies and oncological trials With MTZ since 2012.


Anna Olak-Popko MD,

Clinical Research Site Deputy Director

Specialist in Internal medicine and anesthesiology. Over 15 years experience in clinical trials, bioequivalence and medical experiments, PI in several trials. With MTZ since 2003.

Professor Wiesław W. Jędrzejczak, MD, PhD,


A clinical specialist in internal diseases, hematology, oncology and clinical transplantation.
Chairman of the Committee for Immunology and Etiology of Human Infections of the Polish Academy of Sciences, former head (now a professor at this Clinic) of the Department of Hematology, Oncology and Internal Diseases of the Medical University of Warsaw in Warsaw, former national consultant in the field of hematology.
Author of several hundreds of scientific publications.
Winner of the Foundation for Polish Science Award and the Clinical Achievement Award European Society for Blood and Marrow Transplantation.

Agnieszka Kardynał, MD, PhD,


A dermatologist-venereology specialist with several years of experience in conducting clinical trials, mainly in the field of psoriasis and moderate to severe atopic dermatitis. Doctor of medical sciences (doctoral dissertation: Non-invasive imaging methods in the diagnosis of early skin melanoma). Experienced diagnostician dealing with videodermoscopy on a daily basis, including the prevention of pigmented nevi. Clinician treating patients with psoriasis, atopic and seborrheic dermatitis, eczema, actinic keratosis, mycosis, acne and other dermatological diseases. Author and co-author of several Polish and foreign scientific publications in the dermatology field.

Professor Grzegorz W. Basak MD, PhD,


Medical Doctor, head of the Department and the Clinic of Hematology, Transplantology and Internal Diseases, MUW. From 2017 Chairman of the Complications Group of the EBMT. 2003 he graduated from the MUW. In 2005 he was awarded a PhD degree. Internships-Temple University, Philadelphia and University of California, San Diego. Specializations: internal diseases, hematology, clinical transplant. 2011-2017-Secretary of the Working Group for Complications and Quality of Life of the EBMT. 2012-habilitated doctor. Top500 Innovators scholarship. 2019-titular professor. Co-founder of Saventic Health dealing with innovative solutions in the field of the diagnosis of rare diseases and the Human Biome Institute providing access to intestinal microbiota transfer technology. Co-author of>100 publications.

MTZ Clinical Research


  • Clinical operations started in 2002
  • Conducted 260 clinical studies, among others first human applications (FIH), multiple applications (MAD), drug-related interactions (DDI) and proof of concept (POC)
  • Over 6200 randomized subjects


Conducted clinical trials:

  • Early Clinical Development – here
  • Bioavailability and Bioequivalence – here
  • Biological Studies – here
  • Biosimilar Studies – here
  • Late Clinical Development – here
  • Studies in Smokers – here
  • Vasoconstrictor Assay Studies  (VAS)/ Corticosteroid-tested – here


Phase graph

Therapeutical area

Therapeutical Area graph


  • Amyloidosis (AL)
  • Acne vulgaris
  • Acute Lymphoblastic Leukemia (ALL)
  • Acute Myelogenous Leukemia (AML)
  • Advanced Carcinoma of the Ovary
  • Alopecia areata
  • Aphthous Ulcers
  • Asthma
  • Atopic Dermatitis
  • Biliary Cancer
  • Cancer pain
  • Chemoteraphy Induced Anemia (CIA)
  • Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL)
  • Chronic Lymphocytic
  • Chronic Myelogenous Leukemia
  • Chronic obstructive pulmonary disease (COPD)
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Endometriosis
  • Follicular lymphoma
  • Functional Cognitive Deficiencies
  • Glycemic Index
  • Hemophilia B
  • Hodgkin Lymphoma
  • Idiopathic thrombocytopenic purpura
  • Impaired Hepatic Function
  • Mantle Cell Lymphoma
  • Metastatic breast cancer
  • Metastatic Solid Tumors
  • Multiple Myeloma
  • Myelofibrosis
  • Neuropathic pain
  • Neutropenia
  • Non-Hodgkin Lymphoma
  • Non-small cell Lung Cancer with PD-L1 +
  • Orthostatic Hypotension
  • Osteoarthritis of the hip or knee
  • Pancreatic Cancer
  • Peritoneal cancer
  • Plaque Psoriasis
  • Psoriatic arthritis
  • Rheumatoid arthritis
  • Telangiectasia and lipodystrophy
  • Type 2 diabetes mellitus
  • Uterine fibroids
  • Water retention problems

read more

MTZ Quality

Quality & Security

Certified Early Phases Clinical Research Unit fulfilling the EU legislation requirements (Guidelines for Phase I clinical trials)


Strict implementation into Quality Management system:

  • Polish and EU law
  • Current GCP requirements (Integrated Addendum to ICH E6 (R2) document)
  • EU standards
  • ISO 9001 – 2015


Security: Procedures complying with PN ISO/IEC 27001 and Company Policy

Quality Policy


Customer Satisfaction Survey

ISO certificate

In August 2009, our company obtained a Certificate of Approval for Quality Management System according to ISO 9001:2008.
A recent audit, which took place in June 2018 has confirmed functioning  to management system in accordance with requirements new standard ISO 9001:2015. The Certificate is valid until February 2022.


Currently, the company has a certified quality management system for the following scope of operations: Conduct of contracted medical trials and operation of MTZ Clinical Research Site. Medical services in the field of laboratory diagnostics in the research Centre of MTZ Clinical Research


Inspections and audits

During the last 5 years the Company underwent:


  • 1 FDA routine regulatory inspection
  • 2 Polish routine regulatory inspections
  • 25 audits (before, during and after the clinical studies)


Inspections focused on the conduct of bioequivalence trial and Phase III study and confirmed the compliance with GCP, local regulations and the study protocol.

GCPpl and Transcelerate BioPharma Inc. accreditation

MTZ Clinical Research Unit (CRU) implements for its employees the training program “ICH E6 Good Clinical Practice for Investigators and Site Personnel” accredited by GCPpl and  TransCelerate BioPharma Inc.