BioResearch Group Sp. z o. o. was established by Dr Katarzyna Jarus-Dziedzic.
For the past fifteen years Dr Jarus-Dziedzic, highly experienced physician (neurosurgery and neurotraumatology specialist), investigator and manager, 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.
In 2019 we were certified by Qualology in the area of processing samples for clinical trials (GCLP Certificate).
We plan to introduce also GMP (Good Manufacturing Practice) in the area of repacking investigational products, randomization, preparing products for dispensing for investigators.
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 2019 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:
1. A phase I, Open-label, Multicentre, Dose Escalation Study to Assess Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects with Advanced Solid Malignacies
2. A Phase I, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HMPL-523 in Patients with Relapsed or Refractory Lymphoma
3. A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-689 in Patients with Relapsed or Refractory Lymphoma
4. A randomized, double-blind, 2-period, 2-sequence crossover Phase I study with a 1 month run-in period to examine the effect of cladribine tablets on the pharmacokinetics of a monophasic oral contraceptive containing ethinyl estradiol and levonorgestrel (Microgynon®) in pre-menopausal women with relapsing multiple sclerosis (RMS)
1. Randomized, double-blind, placebo-controlled, multicenter Phase 2 trial assessing the effect of IMU-838 on disease activity, as measured by magnetic resonance imaging (MRI), as well as safety and tolerability in patients with relapsing-remitting multiple sclerosis
2. A Phase 2, Double-Blind, Dose-Ranging, Placebo-Controlled Study With Open-Label Extension to Evaluate the Safety and Efficacy of Itacitinib in Moderate to Severe Ulcerative Colitis
1. A phase 3 double-blind randomized study to assess the efficacy and safety of intravenous ATB200 co-administered with oral AT2221 in adult subjects with late-onset pompe disease compared with algucosidase alfa/placebo
We have conducted 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 (PART A)
2. 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 PART B
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
5. A randomized, single dose, cross-over open-label bioequivalence study comparing fluticasone propionate/salmeterol (250/50 mcg/dose inhalation powder) (SALMEX [CELON PHARMA SA] vs SERETIDE DYSK 250 [GLAXOSMITHKLINE EXPORT LTD]) without charcoal blockade.
6. A randomized, open-label, sungle-dose, two-period, cross-over with oral drug bioequivalence study of film-coated tablets of Febuxostat 120 mg [Gedeon Richter Polska Sp. z o. o.] with film-coated tablets of Adenuric 120 mg [MAH: Menarini International Operations Luxembourg S.A.] in healthy, adult volunteers under fasting conditions
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.
Jolanta Petz (MSc), Senior Coordinator
- Specialist in laboratory medicine graduated from Warsaw Medical University.
- Gained an international experience on University of Reims Champagne-Ardenne as part of Erasmus+ programme.
- She participated in a dermatological project where she was a part of pre-clinical study team, working on etiology and treatment of bullous pemphigoid.
- Clinical research enthusiast, Senior Study Coordinator specialized in early phases clinical trials and bioequivalence studies.
- Mainly responsible for study start-ups, clinical trials conduct, project management, design and analysis of assumptions for clinical trials.
Katarzyna Strużyńska, Senior Recruitment Specialist
Our Recruitment Specialist, Katarzyna Strużyńska, is responsible for all activities regarding contacts with patients. Her main responsibility is to elaborate recruitment strategies for all types of studies, including studies with special populations of patients and contacts with potential Subjects.
Katarzyna graduated from Podkowiańska Medical High School where she studied Physiotherapy. Meanwhile she worked as a receptionist in a hotel. In 2018 she started her job as a Client Advisor in one of the most known Polish banks.
Katarzyna joined BioResearch team in 2018 and started her activities in clinical trials on a position of Recruitment Specialist Assistant. Due to her excellent communication skills she is very efficient and liked by our patients what translates into low SF rate and fast recruitment.
Iwona Karaś, Quality Assurance Specialist, Junior Research Coordinator
Iwona Karaś is Quality Assurance Specialist and Junior Study Coordinator in BioResearch Group sp. z o. o. She graduated from Biotechnology at the University of Agriculture in Cracow. In 2016 she also completed postgraduate studies in the area of Quality Management at AGH University of Science and Technology in Cracow.
She has four years of experience in the quality control area. She started her career in the quality control department in a biotechnology company.
Iwona is responsible for the implementation of the GMP in BioResearch Group. She works in the Department of Quality Assurance and Department of Coordination.
Barbara Kuśmierska, Assistant specialist for Recruitment, As. Research Coordinator
Barbara is Recruitment Specialist Assistant and Study Coordinator Assistant. Her responsibilities are to help in recruitment processes, contact with patients and marketing activities related to the promotion of research. She also helps and cooperates with Study Coordinator in creating clinical trials documentation.
She is graduated from Medical University of Gdansk where she studied Pharmaceutical and Cosmetics Industry. She wrote her master thesis at one of the polish pharmaceutical company at Quality Assurance Department.
Daria Malicka, Laboratory Manager, Junior Study Coordinator
- She graduated from Laboratory Medicine at Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Toruń.
- She is the author of articles, that were published in reputable scientific journals. She also actively participated in scientific conference, during which she had a speech about the role of antioxidants in neurodegenerative diseases.
- During her studies, she completed internships in the hospital laboratories, where she gained experience in the field of laboratory analysis.
- She has an experience in clinical trails phase I and II. She is responsible for processes of samples sampling and processing and she is performing duties related to the support and coordination of clinical studies.
Elwira Szewczyk (MSc), Pharmacy Manager, Junior Research Coordinator
- Master of pharmacy graduated from Medical University of Gdańsk.
- She completed many internships abroad, among others in Spain, Great Britain and Canada, gaining experience in the field of pharmacy as well as R&D.
- Participant in workshops organized by a leading pharmaceutical company.
- She combines the position of a pharmacist and a quality control specialist,
- Her experience in clinical trials is mainly related to I and II Phase studies.
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.
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.