16 years

early phases Clinical Research Unit with full service

3

inspections

50

audits

100

satisfied clients

230

clinical research trials

4500

randomized subjects

1700

biological shipments

10000

subjects in clinical database

MTZ Clinical Research Unit

focuses on phase I, early clinical  development, bioequivalence and phase III studies

 

Founded in 2002 in Warsaw, Poland

 

Services offered:

  • Audits
  • Biological samples processing
  • Clinical study conduct at own clinical research site (32 beds)
  • 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)
  • Pharmacokinetic (PK) analysis through selected partner laboratories
  • Studies registration

Company values

Quality

Cooperation

Honesty

Advantages

  • Proven experience (230 conducted studies)
  • High quality services:
    • ISO 9001:2008 (2009 – 2018)
    • ISO 9001:2015 (obtained in 2018)
    • 3 inspections (FDA and Polish)
  • State-of-the-art Clinical Research Facility with 32 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 volunteers, and ultimately of patients, the conduct of all  clinical research trials is performed in strict compliance with the highest international standards

History

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
Katarzyna Jarus-Dziedzic, MD, PhD

becomes Medical Director

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

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018

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 President MTZ  Clinical Research

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, 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.,

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

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,

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

MTZ Clinical Research

Experience

  • Clinical operations started in 2002
  • Conducted 230 clinical studies, among others first human applications (FIH), multiple applications (MAD), drug-related interactions (DDI) and proof of concept (POC)
  • Over 4500 randomized subjects

 

Conducted clinical trials:

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

 

Phase

Phase graph

Therapeutical area

Therapeutical Area graph

Indications

  • 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

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

 

 

Polityka Jakości   (Quality Policy)

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 August 2021.

 

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:

 

  • 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.