Inspected CRO with own
Clinical Research Site

40

international audits

100

satisfied clients

180

conducted trials

4500

randomized subjects

1700

shipments of biological samples worldwide

10000

subjects in database

Company

MTZ Clinical Research Sp. z o. o. (MTZ)
Inspected CRO with its own Clinical Research Site
Focuses on early clinical research development & bioequivalence studies
Offers full service studies
Founded in 2002

Company Values

Quality

Cooperation

Honesty

Advantages

Proven experience (180 conducted studies)
High quality services (EN ISO 9001:2008 obtained in 2009)
State-of-the-art Clinical Research Facility
Highly trained and experienced study team providing accurate, reliable, and consistent data
Respect of project timelines

Company mission

To ensure the safety of our volunteers, and ultimately of patients, we conduct all our clinical research procedures in strict compliance with the highest international standards.

History

2002
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

2002
MTZ establishes a medical site (NZOZ)

and starts performing clinical trials.

2002
2003
First Bioavailability Study
2003
Katarzyna Jarus-Dziedzic, MD, PhD

becomes Medical Director

2003
2004
First Phase I Study
2004
Registration of subject database
2004
2005
2006
Anna Bereda

becomes Quality Assurance Coordinator

2006
2007
Extensive renovation of the Clinical Site
2007
2008
MTZ Clinical Research starts acting as CRO

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

2008
Teresa Brodniewicz, MSc, PhD

becomes President

2008
Creation of independent Quality Assurance Department
2008
2009
ISO 9001:2008 Quality Certificate

obtained from DAS CERTIFICATION Ltd. accredited by UKAS

2009
2010
Extension of services to include Oncological Products Studies
2010
Opening of a Pharmacy Unit

equipped with a laminar flow cabinet

2010
2011
Małgorzata Drop, MSc

becomes Quality Manager and Quality Management System Representative

2011
Closing of MTZ office in Montreal, Canada
2011
Registration of MTZ US Clinical Research, LLC.

a partner company in Massachusetts, USA

2011
2012
Anna Dryja, MD, MBA

becomes Clinical Research Site Director

2012
2013
Anna Olak – Popko, MD

becomes Clinical Research Site Deputy Director

2013
Registration of Medical Analysis Laboratory of MTZ Clinical Research
2013
2014
ISO certification extended to medical services

in MTZ’s Laboratory of Medical Analysis

2014
2015
Book „ Clinical Trials”

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

2015
Launch of new website
2015
2016

Core Team

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

All members of our team are obliged to comply with ICH GCP requirements EU and Polish legislation and Company’s Standard Operating Procedures.

Teresa Brodniewicz

Teresa Brodniewicz
MSc PhD, President

 

Biochemist in clinical research for over 20 years
International experience in research and development
Founder, majority owner and President of MTZ Clinical Research
President of Polish Society of Good Clinical Practice GCPpl since 2013
Author of several papers in the area of coagulation, wound healing and clinical research, editor of book “Clinical trials” published in CeDeWu

Anna Dryja

Anna Dryja
MD MBA, Clinical Research Site Director

 

Specializing in clinical oncology,
17 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 POPKO

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., Coordinator, Team Manager

 

Experienced in different areas of clinical research
Coordinator of several Phase I – III and Bioequivalence studies
With MTZ over 10 years

Małgorzata Drop

Małgorzata Drop
MSc, Quality Manager

 

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

Zbigniew Proba
MSc, PhD, Director of Financial Affairs

 

Co-founder MTZ Clinical Research
Author and co-author of 23 scientific papers and US patent

Agnieszka Lewczuk

Agnieszka Lewczuk
MSc, Laboratory Affairs Manager

 

Biotechnologist and laboratory diagnostician with over 8 years of experience in clinical trials
Laboratory procedures management in close cooperation with local and central laboratories
Regular participation in many external trainings in the field of laboratory medicine and clinical trials
With MTZ since 2007

Marta Zakrzewska

Marta Zakrzewska
MSc, Senior Marketing Specialist

 

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

Publications
MTZ Clinical Research

Experience

Operations started in 2002
Conducted about 180 clinical projects with over 5000 randomized subjects.

Phase

Phase graph

Therapeutical area

Therapeutical Area graph

Indication

  • (AL) Amyloidosis
  • 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

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MTZ Quality

Quality

Strict implementation of all current GCP requirements, European Standards and ISO 9001-2008 incorporated into our Quality Management System.

Audits and Inspections

During the last 5 years our Company underwent:

  • 25 Audits  (before, during and after the clinical studies)
  • 2 Polish Routine Regulatory Inspection which focused on the conduct of the bioequivalence trial and concluded in the confirmation of compliance with GCP, local regulations and the study protocol.