BioResearch Group Sp. z o. o. was established by Dr Katarzyna Jarus-Dziedzic, highly experienced physician (neurosurgery and neurotraumatology specialist), investigator and manager.
For the past fifteen years Dr Jarus-Dziedzic has been responsible for successful clinical operations and medical management of clinical study projects for leading pharmaceutical companies as well as management and development of medical research teams. Additionally, for the past five years she has been the President of The Board, Medical Director and Investigator at Clinical Research Group (research and development centre specialising in phase II and III clinical studies).
On December 2012 Dr Jarus-Dziedzic co-founded and until 2016 succesfully led an early phases, bioequivalence and bioavailability clinical site (as a President of The Board, Medical Director and an Investigator). Due to her involvement, the Site succesfully conducted several projects with over a thousand healthy volunteers and patients.
Based on her professional experience and excellent management capabilities, Dr Jarus-Dziedzic decided to establish new Clinical Site, BioResearch Group Sp. z o. o.
As a primary and co-investigator, Dr Katarzyna Jarus-Dziedzic has conducted more than 180 clinical studies in the area of:
- oncology (breast/colon cancer)
- haematology (leukaemia, lymphoma, Hodgkin’s lymphoma, multiple myeloma)
- dermatology (I and II phase)
- others studies (including medical experiments).
Knowledge and international experience of Dr Jarus-Dziedzic, her passion and professional values are the four pillars of the development of the BRG brand. Our standards of excellence are very high so we are confident that our Customers can depend on a transparent and open data exchange while our patients can rely on safety, respect and protection of their rights.
Our mission is to come closer to Polish people and to ensure them an easy access to participation in clinical studies.
We would like to provide our patients with equal opportunities of benefiting from the latest achievements of researchers right from the early stage of their work, without having to wait for the completion of later stages of clinical studies.
The exceptional character and uniqueness of our work is related to the concept of creating a network/group of our own research sites within the infrastructure of hospital wards selected from the category of effectively managed hospitals in Poland.
To the sponsors, it creates unlimited possibilities of complementary and flexible cooperation in carrying out their clinical research projects, with BRG having an unlimited research potential in a wide field of therapies.
BRING MODERN MEDICINE TO EVERYDAY LIFE
As we want to be unique and competitive in the Polish market, we decided to increase standards of conducting clinical studies in an administrative way as well. By the end of 2017, we plan to introduce following certificates:
- GMP (Good Manufacturing Practice) in the area of repacking investigational products, randomization, preparing products for dispensing for investigators
- GCLP (Good Clinical Laboratory Practice) in the area of processing samples from the start-up point (including analytical plans for site’s part of the study) until shipments to central laboratories.
We are also developing electronic barcode system for our internal laboratory which will allow us to collect data on the highest possible standard and due to implemented audit trail it would be possible to follow the samples circulation from the moment of collection until shipment.
By the end of 2018 we plan to implement electronical documentation for collecting data from clinical studies (electronic source documentation). The system will be able to integrate with some eCRFs and send data after reviewing directly to Sponsor eCRF.
Our quality assurance system will cover all satellite locations so to assure standardisation of work. The system of SOPs was adapted to our vision and includes general and site specific procedures.
BioResearch Group is a relatively young company, founded in 2016, but our Team have more than 15 years of experience in the field, gained in other research sites, which were also developed with our cooperation and involvement. We are very familiar with the European and worldwide standards and we work in strict observance of their requirements.
Our key managers have versatile competences in running international research projects, because quality comes at the top of our priorities.
We have been supporting our Clients since 2016, engaging our entire team in providing research services to key pharmaceutical and bio-pharmaceutical companies. Regardless of the dimension and scope of a particular project, every Sponsor is guaranteed the same, state-of-the-art approach and quality down to the tiniest detail.
We treat every project individually and we approach every Sponsor with great attention and understanding of its requirements, so we attach importance to substantive discussions aimed at determining and compliance with the Sponsor’s needs.
Based on the experience, knowledge and involvement of Dr Jarus-Dziedzic and her team, BioResearch Group started its activity to realize a new vision of clinical studies, conducted and popularised amongst an increasingly wide group of society.
We are conducting following clinical studies:
FIRST IN HUMAN
1. One centre, single ascending dose and double blind multiple ascending dose, safety and pharmacokinetics phase I study of CPL-500-036 compound in healthy volunteers.
2. Multicenter, Phase I, randomized, open-label, parallel group, single dose, single period, two-stage design trial to demonstrate bioequivalence of a 1000 mg testosterone undecanoate solution for intramuscular injection - 2nd edition
We have conducted following clinical studies:
1 ST PHASE
1. One-centre safety and pharmacokinetics Phase I study of inhaled Esketamine in healthy volunteers with two single ascending dose and one double-blind multiple ascending dose parts (Part A)
2. One-centre safety and pharmacokinetics Phase I study of inhaled Esketamine in healthy volunteers with two single ascending dose and one double-blind multiple ascending dose parts (Part B)
3. One-centre safety and pharmacokinetics Phase I study of inhaled Esketamine in healthy volunteers with two single ascending dose and one double-blind multiple ascending dose parts (Part C)
1. A randomized, single dose, cross-over open-label bioequivalence study comparing fluticasone propionate/salmeterol (500/50 mcg/dose inhalation powder) (SALMEX [CELON PHARMA SA] vs SERETIDE DYSK 500 [GLAXOSMITHKLINE EXPORT LTD]) with charcoal blockade.
2. A randomized, single dose, cross-over, open-label pharmacokinetis pilot study in healthy volunteers comparing fluticasone propionate from multiple batches of flovent diskus [GSK] to fluticasone CP [CELON PHARMA SA]
3. Multicenter, Phase I, randomized, open-label, parallel group, single dose, single period, two-stage design trialto demonstrate bioequivalence of a 1000 mg testosterone undecanoate solution for intramuscular injection
4. A randomized, open-label, single-dose, 4-way cross-over dose ranging study of tiopropium bromide delivered via oribicel or handihaler under fasting conditions in healthy volunteers
1. A randomized, single blind, uni-center pilot study in healthy volunteers, comparing the volume of blood obtained after the puncture of the finger with four types of lancets.
2. A randomized, single blind, uni-centre study in healthy volunteers, to determine capillary blood volume and pain perception obtained in a process of puncturing with different safety lancets.
BioResearch Group Team is trained, motivated and guided by Katarzyna Jarus-Dziedzic, who has multi-year experience in performing clinical studies including pharmacokinetic/bioequivalence studies, early phases (I, II) of different designs with healthy volunteers, special populations of healthy volunteers, as well as populations of subjects with special health conditions and patients with various diseases. Due to the professional management by the experienced person, unique and valuables employees are recruited to the study team, for whom working in the field of clinical trials is a passion,
The experience, knowledge, proficiency and motivation of management and medical, pharmacy, laboratory team and excellent knowledge of ICH-GCP rules and work according to SOPs, instructions, protocol, applicable law ensure successful conduct of even logistically difficult and complicated clinical trial.
We focus on continuous development and self-improving by various external and internal trainings on regular basis which includes general, procedural, study-specific, and obligatory, annual emergency and ICH-GCP training.
Our study team includes investigators and nurses who are experienced and who practice daily in clinical units or multidisciplinary outpatients clinics. The Team is fully qualified in drug administration in different forms and time conditions, sequential, intensive and frequent blood sampling, special urine collections, and ECG, vital signs and spirometry.
Wioletta Ładno, PhD
Wioletta Ładno holds a doctorate degree in the field of pharmaceutical sciences at the Faculty of Pharmacy with Laboratory Medicine at the Medical University of Warsaw.
She conducted researches on the central nervous system at the Department of Human Physiology and Pathophysiology in the Centre for Preclinical Research and Technology (CePT) in Warsaw. In particular, she was interested in the investigation of control of ion leak potassium TREK-like channels by adrenergic receptors in pyramidal neurons of the medial prefrontal cortex (mPFC) in rats at different ages.
She is a co-author of high-quality scientific papers. For many years she was a lecturer in human physiology and pathophysiology for students of Pharmacy and Laboratory Medicine (full-time course) as well as Laboratory Medicine (postgraduate studies) at the Medical University of Warsaw.
She completed postgraduate studies in the area of methodology of clinical trials at the Centre of Postgraduate Training at the Medical University of Warsaw. A member of the Polish Neuroscience Society (PTBUN).
She currently works as a Medical Writer and Marketing & BD Manager in BioResearch Group Sp. z o. o.
Marta Marek, MSc
Marta Marek, Operational Director in BioResearch Group sp. z o. o., graduated from Biotechnology at the Faculty of Chemistry at Wrocław University of Technology. In 2009 she also completed postgraduate studies in Medical Diagnostics at the Medical University in Lublin, in 2017 post-graduated studies in the area of Quality Management and in 2017 started Project Management post-graduate studies. Additionaly she took part in many trainings and conferences connected to clinical trials.
She has several years of experience in laboratory diagnostics. Since 2013 professionally associated with clinical trials. Initially she worked at the BioVirtus Research Site as a Laboratory Coordinator and later on as a Quality Control Specialist. She also gained experience at the Clinical Research Group as a Clinical and Marketing Manager responsible for clinical operations and projects management. Thanks to her extensive knowledge and above-average skills, since 2016 she has been Operational Director of the BioResearch Group, where she is responsible for start-up activities and project management of currently conducted clinical studies.
Her experience in clinical studies includes both bioequivalence studies as well as phase I-III studies in the field of oncology, dermatology, pulmonology and others.
Joanna Mosiołek, MSc
Joanna Mosiołek, our Medical Manager, is a very experienced and well-organized person. Her commitment and great analytical skills make her one of the most respected employees in the company. Joanna is responsible for organization of clinical part of the study and leads a team of over than 20 nurses.
Joanna graduted from Biology in the Łódzki University in Łódź. She specialized in Medical Biophysics and Bioinformatics. During the study she completed an internship in medical laboratory, when she gained experience in working with biological materials. She also was an active member in student associations.
As a Medical Manager, Joanna has worked in BioResearch since 2017, being great in this role. She bounded her professional life with clinical studies in 2016, when she started her first job in early phases clinical site. Since then, she is developping in this area.
Monika Juśko, MSc
Alekandra Kania, MSc
Monika Stemler, MSc
Monika Stemler works as a Study Coordinator in BioResearch Group Sp. z o. o. Due to her excellent organizational skills, huge commitment to dedicated tasks, she has become one of our best team members in a very short time. She started her professional life in clinical trials in September 2017.
Monika graduated from Chemistry at the Warsaw University, where she had experience both in laboratory work and in maintaince of projects documentation.
Meanwhile she took part in "Monitoring Clinical Trials" and "English in Clinical Trials" course.
ANNA BOROWIECKA, MSc
Anna Borowiecka is a highly qualified and experienced auditor and QA Specialist with other 9 years of experience in clinical trials.
As a QA Director she prepared QA Department plans and execution, subcontractors initial assessment (GCP, GCLP, IMP distribution, archiving, IMP storage and distribution), internal proceses design, auditing and internal consulting, proces maps implementation, ongoing implementation of risk assessment and risk mitigation plans in company activities, corrective actions database design and implementation for adequate non-compliances trending and ensuring internal processes improvement, User Acceptance Tests set up for internal electronic systems for SOP and CAPA management, ISO 9001:2008 re-certification, Line Management (Team of 3 QA auditors).
As a QA Manager she conducted audits of internal country processes, subcontractors assessment in area of GCP and Patient Oriented Programs, FDA site inspections prep and organization, providing internal training, SOP writing, CAPA management in GCP area, compliance assessment at site.
As a Quality Assurance Officer she was an internal auditor (ISO 9001:2008), she was responsible for corrective\ preventive actions initiation and follow up, internal audit of TMF based on internal and Sponsors' SOP, drafting\ writing internal SOPs & instructions (area: clinical trial - monitoring, site contracting, administrative (HR, IT), quality), preparation to EMA inspection and EMA inspection management
TOMASZ CIĄĆKA, MD, PhD
Doctor of Medicine Science, Tomasz Ciąćka is a graduate of the Medical Academy in Białystok. A doctorate degree in medical sciences (in the field of surgery) obtained in 2013 in the General, Vascular and Transplantology Surgery in Warsaw Medical University.
For many years, he has been dealing with vascular and endoscopic surgery, aesthetic phlebology and minimally invasive methods of treating lower limbs varices and vascular spider veins. The speciality in the general and vascular surgery became at the General, Vascular and Transplantation Clinic at Warsaw Medical University. During the study he started to be interested in minimally-invasive surgical techniques.
During the foreign and national internships he participated in the plastic surgery with aimed at reconstructions after injuries, tumours and accidents. He has gained the experience among other in Clinic of Plastic and Reconstructive Surgery in Hannover, University Clinic in Mainz, St’ Vincent Hospital in Izrael.
Doctor Ciąćka implements the screening test program in order to atherosclerosis of the lower limbs – Ancle-Brachial-Index) for the early detection of disease and early appropriate vascular therapy.
He is an excellent physician with more than 15 years experience in the field of clinical trials as an investigator. He conducted numerous early phases clinical trials, bioequivalence, bioavailability, drugs interactions. He participated in more than 30 specialised course and conferences, both foreign and domestic.
Currently he works as an outstanding vascular surgeon in Specialist Medical Practice, Med. Bis in Żyrardów, Lux Med and Investigator in the Bioresearch Group Clinical Research Centre. He continuously gains more and more knowledge. He is a recognized authority in vascular surgery
DARIUSZ DZIEDZIC, MD, PhD
Doctor of Medical Sciences Dariusz Dziedzic is a graduate of the Wrocław Medical Academy. In 2007 received certificate of the European Board of Thoracic and Cardio-Vascular Surgeons, Member of the Polish Society
of Cardio-Thoracic Surgery and European Association for Cardiothoracic Surgery.
For many years he has worked in diagnostic and cancer diseases of chest. The key areas of the interest include endoscopic diagnosis in lung cancer.
For many years he has been involved in the development of modern techniques for early detection of airway neoplasms - autofluorescence bronchoscopy, narrow banded bronchoscopy (NBI) and mediastinal ultrasonography (EBUS) - ultrasonography (EBUS). In this field he is considered authority and the author of many trainings, lectures and publications.
In addition, he is a recognized authority in the treatment of upper gastrointestinal diseases, with particular emphasis on esophageal cancer and gastroesophageal reflux disease.
Co-author of the publication "Recommendations for diagnostic and therapeutic treatment in malignant neoplasms in adults" under the auspices of the Polish Oncological Union, currently the most important therapeutic guide in oncology in Poland.
For many years has developed modern methods of palliative treatment of esophageal diseases in advanced forms of esophageal and lung cancer and minimally invasive surgical techniques for benign esophagus diseases. Recognized authority in the field of surgical treatment of thoracic disorders.
He has many years of experience in clinical trials in various centers, conducted about 30 phases I-III studies and nearly 50 bioequivalence studies.
MAŁGORZATA JONAK, MD
Medical doctor, Małgorzata Jonak is a graduate of the Medical Academy in Łódź. She has many years’ experience in cardiology, ECG interpretation, obesity, androgen and metabolic disorders, as well as autoimmune diseases. She is an excellent investigator with almost 20-years experience in work with the patients. She participated in approximately 60 studies, including bioequivalent and I-IV phases studies.
For many years she was the Medical Director and the principal investigator in the large clinical trial site. Since 2013 she has been working as an investigator in the BioVirtus Clinical Research Group, Clinical Research Group and BioResearch Group, and in BioResearch Group since 2017.
Doctor Jonak continuously gains more and more knowledge participating in numerous courses and trainings, among other Progress in internal diseases 2016, ICH GCP 2016, Endocrynology CMKP 2016. She completed postgraduate-studies in Medical Law, Bioethics and Sociology in Medicine in Warsaw University. A speaker in the international scientific conferences. She is a recognized and well respected authority in the field of internal diseases.
AGATA KĄCKA, MD, PhD
Doctor of Medical Science, Agata Kącka is a graduate of the Medical University in Warsaw, where also completed speciality in Anaesthesiology and Intensive Therapy. She has many years’ experience in transplantation anaesthesiology, acute pain management, anaesthesiology in vascular surgery and general anaesthesiology risk in obese patients. In 1999 she passed the degree examination for PhD in medical science in Warsaw Medical University. Doctor Agata Kącka has also gained an experience in Great Britain working in Wycombe General Hospital and in France in Livers Transplantology Center. Currently she is an assistant professor at the IInd Anaesthesiology and Intensive Therapy Clinic of Warsaw Medical University.
She actively participates in many specialist training events and courses in the field Anaesthesiology and Intensive Therapy. Agata Kącka has exceptionally experience in clinical trials as an investigator, she conducted numerous phase I and III clinical trials. Moreover she is the co-author of the publication “Operational Risk in patients with giant obesity” and author of about 50 scientific publications. She is a recognized authority in the field of anaesthesiology.
DOROTA OSIŃSKA, MSc, QP
Dorota Osińska is a Pharmacist with over the 20 years experience in pharmaceutical industry. She worked in the research department of a pharmaceutical company developing and implementing oral pharmaceutical forms. She has been a lead expert in validation and audits in Quality Assurance and Quality Assurance and Qualified Operations Manager at Polfa Warszawa S.A. (Polpharma Group) as well as the Manager of Compliance and Quality Assurance Compliance Team at Agila Specialties Polska (Mylan Group).
She participated in designing and launching new production areas and upgrading existing ones. As a quality specialist, she participated in the implementation of Good Manufacturing Practice requirements. She was an internal auditor and external auditor, auditing the manufacturers of active substances, packaging materials, medical devices, contract manufacturers and pharmacovigilance.
She oversaw the development of quality contracts, development of DGMW, complaint handling, qualitative documentation management, deviation analysis, supplier qualification, corrective and preventive actions, internal training, internal inspections and external audits.
KAMILA PADLEWSKA, MD, PhD
Doctor of Medical Sciences, Kamila Padlewska is a graduate of the Medical UnivercityAcademy in Warsaw, consultant dermatologist.
For several years, she has been also dealing with aesthetic dermatology and laser dermatology. Since 1999 she has been practicing private dermatology practice.
In 2014 she founded Oricea Clinic. From many years she is currently the Laboratory of Cosmetics Analysis Chief executive Manager at IZIS, the Cosmetic and Medical Co-operative in Warsaw, the Head of Postgraduate Fertility Professor at the Warsaw Academy of Cosmetics College of Cosmetic and Health Care in Warsaw and works as a dermatologist and a clinical researcher at the Clinical Research Group.
For many years, she has participated in numerous training events and courses, including ICH GCP 2016. She is one of the Leading Health Pprofessionals of the World. She received the DeanRector's Award from the Medical University of Warsaw for her work on the epidermodysplasia verrucous verruciformis and the award from the Polish Society of Dermatology for her work on the role of topoisomerase in the pathogenesis of scleroderma. Co-author of the publication "A survey of work-related skin diseases in different occupations in Poland" and aAuthor of books and numerous scientific publications.
For many years, she has participated in clinical trials as an investigator. She is a recognized authority in aesthetic and laser dermatology.
MARIUSZ PIOTROWSKI, MD, PhD
Doctor of Medicine, Mariusz Piotrowski is a graduate of the Medical Academy in Warsaw. He obtained the Medical Science Doctor degree in 2013. For many years he has been involved in transplant anesthesiology, acute pain management, anesthesiology in general surgery and general anesthesiology risk in obese patients. He completed speciality in the Anesthesiology and Intensive Therapy in 1991. For many years professional associated with Anesthesiology and Intensive Therapy Department at Central Clinical Hospital in Warsaw. Since 2006 he has been working as senior assistant at West St. John Paul II Hospital in Grodzisk Mazowiecki, and since 2007 in the II Clinic of Anesthesiology and Intensive Therapy in the Independent Public Central Clinical Hospital. He hold the position of investigator in Clinical Research Site BioVirtus and currently in BioResearch Group.
He is co-author the publication "Operational Risk in Giant Obesity Patients" and author many scientific publications, including "Multiple organ failure after a fall from heights complicated by cardiac rupture and subacute cardiac tamponade" in Anesthesiology Intensive Care Journal.
His professional achievement include many early phases clinical trials and bioequivalence studies.
He work excellent in that role, gaining wide recognition from patients and study team. He is outstanding authority in the field of anesthesiology.