Based on our professional approach, BioResearch Group offers a set of services that meets the Sponsors’ needs starting from consultations at the earliest stage of the study (concept, design and study assumptions) up to final integrated clinical study report.
- BioResearch Group is a clinical site that offers the Sponsors:advisory services in the area of the possibility of conducting clinical trials in Poland,
- consultations with scientists, specialists and experts in the field of choosing appropriate strategies,
- support in the process of designing study conduct, writing study protocols and Investigator’s Brochure,
- preparing Informed Consent Forms (ICF) for Subjects adjust it to the specific protocols,
- assisting (or performing) in the process of the submission of documentation to regulatory authorities,
- communication with the authorities on a professional level (including representing the study while taking part in Ethical Committee meetings),
- permanent contact with the Sponsor/CRO including periodical study status and recruitment reports (communication in Polish and English).
Before the beginning of each study, we conduct general and study-specific training for the study Team (i.e. investigators, nurses, laboratory technicians, coordinators and pharmacists). In order to popularize the knowledge and standards requirements typical for early phases. we regularly organize external trainings and workshops.
We prepare study-specific medical, laboratory and pharmaceutical records (forms, logs, patients’ cards, instructions, manuals etc.).
We propose to conduct studies according to our procedures and study specific manuals (pharmaceutical, laboratory, medical) which are always based on specific protocol requirements.
To assure the proper conduct of the study and enrich our offer, we propose services which are outsourced in our subcontractors. We cooperate with local laboratories and diagnostic centers equipped with CT, MRI and other diagnostic equipment. Due to conducting studies in different locations, especially in hospitals, we have an easy access to specialized equipment and sophisticated treatment methods.
BioResearch Group leads an active recruitment amongst healthy people and patients so we have access to the wide population of Subjects.
Due to the own dedicated for recruitment website www.udzialwbadaniu.pl, we can influence on awareness about clinical trials amongst potential Subjects. Information about planned and ongoing studies as well as news and events concerning the site activities can be found on the website.
Our database of healthy volunteers and patients is improving, every day we have up to about 40 - 50 new Subjects. Additionally we conduct advertising campaigns in local newspapers, social media and amongst Subject who have already cooperated with the site. Taking into account demanding of early phases clinical trials, bioequivalence, bioavailability studies and medical experiments, we implemented recruitment strategies addressed for healthy volunteers. As a result our database is a source of Subjects who are interested in participating in the trials and who want to contribute to the development of new drugs or medical devices.
We have also access to special populations of healthy volunteers: smoking, non-smoking, with habits, elderly males and females, post-menopausal females, overweight/obesed and many others.
The Subjects database is registered by national respective authority and is secured by dedicated server by highest standards of data protection and also has dedicated interface to process subjects’ data (medical, demographic, participation in clinical trials)
We use network of collaborating physicians, specialists and multidisciplinary clinics as well as two outpatients clinics: BRG Medical Center and CRG Clinical Center to have access to an even wider population of patients in various diseases indications, such as:
- cancer (solid tumors:, breast, stomach, pancreas, liver, lungs, oesophagus, pulmonary )
- psoriasis, atopic dermatitis, rosacea
- endometriosis, uterine fibroid
- asthma, COPD
- hepatic failure Child-Pugh A, B, C
- chronic viral hepatitis type B and C
- cardiac disease: hypertension, cardiac arrhythmia, coronary heart disease
- degenerative diseases, chronic pain.
- bipolar disorder, depression
- renal failure
BioResearch conducts full range of pharmacy procedures, which cover all aspects of investigational product circulation between Sponsor, Site, Subjects. We offer performing pharmacy procedures by certified and experienced Pharmacists, who are well-trained and educated, with GMP and GCP rules knowledge. The procedures are conducting in accordance with protocol requirements, applicable law and international standards as well as with our internal SOPs. Due to our quality control system, we track the investigational products flow and record data using our internal or Sponsor’s documentation.
We perform following activities:
- full management and accountability of the investigational products from the time of receiving from Sponsor until their return to Sponsor after study completion
- IP storage in facilities with controlled and monitored access only for authorized Site’s personnel; we offer possibilities of IP storage in different temperature: room, cooling, freezing and deep freezing conditions
- randomization of investigational products according to our internal or Sponsor SOPs
- repacking and relabeling investigational products which also includes preparing labels and their preparing for administration to the study Subjetcs
- monitoring of temperature and humidity conditions in devices and facilities for IP storage; the electronic monitoring system has also implemented an alarm system which sends messages to designated personnel in case of any critical situation occurrence (such as power failure). The system constantly records data which is stored on our internal server and available on any demand (possibility to print the temperature charts with given specified date and time range).
We cooperate with the nearby hospitals while conducting studies which demand using laminar flow chamber for preparing investigational products. This service is maintained according to our internal procedures in professional cytostatic department by our qualified Pharmacists and with assuring confidentiality and security of information. The department guarantee the highest quality of facilities and equipment which is regularly checked and audited by our quality control system.
As we want to be unique and competitive in the Polish market, we decided to increase standards of performing pharmacy procedures. We are preparing to introduce GMP (Good Manufacturing Practice) in the area of repacking investigational products, randomization, preparing products for dispensing for investigators.
The essential condition for assurance of the highest possible quality services is fully trained and educated personnel and professional team consisting of physicians, nurses and medical and laboratory technicians.
Physicians working in our company are specialist in areas of internal medicine, anesthesiology and intensive care, oncology, pulmonology, dermatology and gynecology. They have a large clinical knowledge in early phases which is constantly developing by regular courses and trainings. Their experience in clinical trials is confirmed by many completed, successful projects.
The nursery team consists of people who have participated in clinical trials for the last couple of years, what ensures the high quality of medical procedures.
All medical procedures in our site are performed according to our standard operating procedures (SOPs) and instructions. All members of medical team participate in specialized trainings from emergency procedures and evaluation of additional clinical examinations results.
All adverse events are monitored and reported on regular basis. Investigators are in constant telephone contact with patients between study visits. Medical personnel participate in 24-hour duty shifts, where health conditions of subjects are carefully assessed and properly reported.
In the clinical part we perform following procedures:
- body weight and height measurements
- collecting blood and urine samples for medical analysis, toxicological and pregnancy tests, 24 hour urine collection
- physical examinations
- demographic interview
- ECG examination (with option of monitoring ECQ recording)
Additionally in the clinical part we have conditions for controlled and safe drug administration under the supervision of investigator (oral, parenteral, intravenous, subcutaneous or intramuscular way). The whole process of drug administration is monitored and recorded for verification of the procedures.
The way of organization of medical department guarantees high security and standard of our services.
Clinical trials have special demandings for processing laboratory samples for analytical , pharmacokinetic (PK) or pharmacodynamic (PD) analyses.
Our goal is to fulfill all requirements set by Central Laboratories, Sponsors and/or CROs and to allow proper samples preparing for analysis of new investigational products in early phases clinical trials.
The laboratory activities are under regular internal quality control system which is guided by experienced QA/QC Team at Site. We strive to achieve the highest possible quality by preparing for GCLP accreditation.
We care about quality assurance and development so we create new laboratory procedures, instructions and study specific manuals depending on the needs of Sponsors. We are developping barcode system so to assure proper samples labelling and their tracking at any point during the study (the system will have implemented audit trail). We strictly cooperate with central laboratories and Sponsors.
We have experienced Laboratory Team (more than 20 Laboratory Technicians who also work in certified accredited medical laboratories - analytical, microbiological), well trained and educated. Each Technician participate in regular laboratory procedures trainings (SOPs, instructions) and has GCP and IATA certificates.
We offer all following services from samples collecting until their shipment to Central Laboratories:
- professional consulting as for laboratory procedures during study start-up activities
- samples labelling and kits preparing including kits storage in controlled temperature conditions
- blood processing (centrifuging, pipetting, processing of large volumes of blood, frequent collecting)
- urine processing (including samples from 24-hour urine collection)
- in-house diagnostic tests such as pregnancy, toxicilogical, cotinine tests,urinalysis (dipstick tests)
- secure samples storage in given conditions (below -20°C, -80°C)
- electronic temperature monitoring system (including alarm system in case of any device or power failure occurance)
- shipment to Central Laboratories (in monitoring conditions)
We care about standardization of our work so we introduced standard operating procedures for every activity in the laboratory.
We propose Sponsors to use our internal documentation (operational documents) which records in details samples flow from the point of collection through delivering to laboratory, centrifuging, processing, freezing and shipment to analytical or central laboratory.
BioResearch Group operates according to the site’s standard operating procedures (SOP) and study protocol requirements. Each study is conducted in accordance with Good Clinical Practice (GCP) as well as local and international regulations (European] Directives, FDA guidlines).
As we want to fulfill all requirements of the Sponsors and assure the highest possible quality, we are introducing following certifications:
- GCLP for laboratory procedures, which will cover full range of laboratory services
- GMP for repacking, relabelling of investigational products
Our SOPs are written by competent and well trained study Team and are based on our knowledge, experience and competency. The SOPs cover all areas from the study planning (study documentation review- protocol, ICF, IB, CRF) and submission to the Ethics Committee and regulatory authorities, through creating documentation for the study conduct (logs, source documentation using appropriate templates) to the writing of the study report.
All procedures starting from start-up, study conduct and its administrative management are under internal quality control system. Each study member before starting any activities in the clinical study is trained from general as well as study specific procedures. We organise regular and mock trainings so to assure the Team is well-prepared for performing any procedure during the study.
Our quality is checked on each stage of study conduct by our internal quality control and regular and study specific internal audits.
Our trainings system, validation and certification of equipment are under quality control.We assure regular services and inspections of the equipment. We also guarantee back-up for all devices used in the study in case of any failures.
All study data and data transfer to the study report undergo 100% quality control (QC) before final QA audit. The results are always discussed and corrective and preventives actions, if needed, are implemented in an urgent mode.
The quality of our team was also ensured by regular external audits and inspections.
Wioletta Ładno, PhD:
EMA: update guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products
In 2016 The European Medicines Agency (EMA), in cooperation with the Committee for Medicinal Products for Human Use (CHMP), the European Commission and the Member States of the European Union (EU) published a concept paper (EMA/CHMP/446302/2016). The concept paper proposed changes to existing guideline published in 2007 on first-in-human clinical trials (FIH) and early clinical trials (CT) with investigational medicinal products (IMPs) (EMEA/CHMP/SWP/28367/07). The concept paper outlined the major areas that needed to be revised in the guideline, to reflect the evolution of practices in the last ten years.
The review took into account the lessons learnt from the tragic incident which took place during a phase I first-in-human clinical trial in Rennes in France in January 2016. The laboratory Biotrial was testing a pain and mood disorder pharmaceutical novel compound BIA 10-2474 for the Portuguese company Bial. The tested drug was administered orally to healthy volunteers. Six men were hospitalized after receiving the drug and one of them died due to serious brain damage. The investigation established numerous clinical trial failures. Biotrial laboratory was too slow to react when the first man became sick. The laboratory also did not warn authorities promptly about the accident as well as did not explicitly ask other participants whether they wanted to stay in the test trial.
After public consultation on the concept paper and draft guideline presented by EMA, the revised guideline has come into effect (EMEA/CHMP/SWP/28367/07 Rev. 1) on 1st February 2018. The new guideline is based on the clinical practice and the conclusions of the clinical trial failures. Updated recommendations are described below.
Recommendations introduced with effect from 1 February 2018
EMA’s recommendations are concentrated on risk identification and improvement of the strategy for managing risk of FIH/early CTs. EMA underlines that during early phase clinical trials, sponsors and investigators should identify the potential factors of risk and apply appropriate risk mitigation strategies. For this reason, FIH/early CTs should be performed using integrated protocols which means that the information generated in previous parts needs to be analysed and integrated into an assessment in a limited timeframe prior to making a decision on proceeding to the next part. All parts, and the criteria to move from one part to another, should be predefined within an integrated protocol, as should possible modifications, based on the totality of available information and the related uncertainty. When definite doses cannot be predefined in all study parts, criteria should be established in the protocol. The integrated protocols should combine a number of different study parts such as Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) as well as interaction investigational medicinal product with food or differences between age groups. Criteria for the dose should be described in detail and based on integrated data from previous study parts and emerging clinical data. Experience, both non-clinical and clinical, with molecules having a similar mode of action can also be useful.
The guideline underlines significant relevance of non-clinical studies in providing PD, PK and toxicology data. The data are important basis for planning and conduct of a FIH/early CT as well as in establishing of therapeutic dose, maximum dose, sequence and interval between dosing of investigational medicinal product. The guideline recommends conducting additional non-clinical testing, to obtain data of relevance for the risk assessment which may include data to support assessment of relevance of animal models, e.g. by using human-derived material.
Sponsor’s responsibility is higher in the light of new recommendations. It is the sponsor’s responsibility to define the degree of uncertainty of the IMP and to identify potential risk(s) at every stage of clinical trial. Sponsor should provide a description of how the risk(s) associated to this will be handled within the design and conduct of the FIH/early CTs. The early clinical development of human medicinal products has an intrinsic element of uncertainty in relation to both the possible benefits and risks of a novel drug candidate. Uncertainty may arise from particular knowledge, or lack thereof, regarding the mode of action of the IMP, the presence or absence of biomarkers, the nature of the target, the relevance of available animal models and/or findings in non-clinical safety studies. In addition, risks may derive from the characteristics of the population to be studied, whether healthy volunteers or patients, including potential genetic and phenotypic polymorphisms influencing pharmacodynamics and pharmacokinetics. The sponsor should ensure that a characterisation of the product including its heterogeneity, degradation profile, product- and process-related impurities is performed. Risk mitigation activities should be proportionate to the degree of uncertainty and the potential risks identified. Sponsor is obligated to review emerging data associated with the safety of trial subject during clinical trial. Protocol should be based on the totality of available information and be modified, if necessary. All safety data should be described in details.
When serious toxicity or mortality is observed, these effects may require follow up studies to determine the cause of death or the mechanism of toxicity if this has not been possible to clarify within the studies undertaken, and if this information is relevant to the clinical trial design or safety monitoring plan. Independent external experts should participate in the study.
Guideline priorities focus on quality of investigational medicinal product formulation. Therefore, as highlighted in the document, the high quality of product formulation has impact on estimation of risks during administration of investigational product. Applicants should demonstrate that the intended formulation is suitable to provide the intended dose. Differences in formulations used for non-clinical studies versus humans
which could impact on exposure should be considered. Moreover, the requirements regarding physico-chemical characterisation are the same for all IMPs while more extensive characterisation may be required for complex or biological products.
In terms of procedures conducted on animals, the document takes notice to respect the 3Rs principles. The principles of the 3Rs (Replacement, Reduction and Refinement) provide a framework for performing more ethical use of animals in testing: replacing animal research with alternatives, reducing the number of animals used and refining experiments to minimise harm and discomfort to the animals.
Development of modern drugs and the safety of participants in clinical trials
Developments in science provide new molecules that might potentially be candidate for modern drugs. It is known that the FIH/early CTs are associated with the highest risk for trial participants due to unknown effects of new investigational medicinal products on humans. Despite the tragic event in France, mentioned above, it was emphasized during the work on the concept paper, that the early phase clinical trials are necessary for further development of medicine and people may not be deprived of access to modern therapies, especially life-saving ones. It is necessary to monitor the risks associated with IMPs given for the first time to humans. Updated guideline is intended to minimise the risk associated with participation in clinical trials.
The Personal Data Officer is: Mrs Dominika Jaśkowiak, tel. +48 500 538 730
1. General information
1. The administrator of your data is BioResearch Group Sp. z o. o. with the registered office in Warsaw, ul. Sokołowska 9/U-2, entered into the Register of Entrepreneurs under the KRS number: 0000651907, for which the registration files are kept by the District Court of capital city Warsaw, 14th Commercial Department of the National Court Register, Tax Identiication Number: 6492175569, REGON: 366072898. Data protection is carried out in accordance with the requirements of generally applicable law, and their are storaged on secured servers.
2. You can contact the Administrator in writing, by traditional mail, to the address of our headquarters or by e-mail to the following address: firstname.lastname@example.org
3. Data Protection Inspector (IOD) appointed by the Administrator supervises the correctness of personal data processing. You can contact the Data Protection Inspector via traditional mail by writing to the following address: ul. Sokołowska 9/U-2, 01-142 Warsaw or via e-mail address: email@example.com
- GDPR - means Regulation of the European Parliament and of the Council (EU) 2016/679 of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data and the repeal of Directive 95/46/EC
- Natural person (“data subject") - is an identifiable natural person
- Personal data administrator ("Administrator") - means a natural or legal person, public body, unit or other entity that independently or jointly with others sets the purposes and means of personal data processing
- Processing entity ("Processor") - processes the data of a natural person at the request of the Administrator
- Personal data - means information about an identified or identifiable natural person.
- Anonymised data - this is data where all information enabling the identification of a natural person has been removed
- Processing - means an operation or set of operations performed on personal data or personal data sets in an automated or non-automated manner, such as collecting, recording, organizing, storing, adapting or modifying, downloading, browsing, using, disclosing by sending, distributing or otherwise type of sharing, matching or linking, limiting, deleting or destroying.
3. Legal basis for the use of data
1. Your personal data is processed on the basis of:
- 6 par. 1 letter f GDPR, i.e. the necessity of processing for purposes resulting from legally justified interests carried out by the Administrator or by a third party, in particular marketing (e.g. conducting direct marketing, as well as investigation and defense in the event of mutual claims).
- 6 par. 1 letter b GDPR, i.e. personal data are processed on the basis of an agreement concluded with BioResearch, the necessity of processing to perform the contract you are a party to)
- 6 par. 1 letter c GDPR, i.e. the necessity to fulfill the legal obligation of the Administrator (e.g. storing VAT invoices in order to fulfill fiscal obligations);
- the Act of 18.07.2002 on the provision of electronic services (Journal of Laws No. 144, item 1204 with later amendments).
4. Method of data processing
1. Your data is processed by us as an Administrator in one or several of the following purposes:
- marketing (basis: Article 6 (1) letter (f) of the GDPR)
- implementation of the provisions of the contract concluded with Leon Kozminski University (Article 6 paragraph 1 letter b) of the GDPR);
- compliance with fiscal and accounting obligations (basis: Article 6 paragraph 1) letter (c) of the GDPR);
- determination, investigation and defense in the event of mutual claims (basis: Article 6 paragraph 1) letter f) of the GDPR);
- marketing (basis: Article 6 paragraph 1) letter f) of the GDPR);
- archives (basis: Article 6 paragraph 1) letter f) of the GDPR
2. Your personal data without express consent will not be processed in an automated manner, including on the basis of profiling.
3. The recipients of your personal data are entities to which the Administrator commissions the performance of activities that involve the need to process your data (processors).
4. Personal data provided in the electronic form shall be treated as confidential and shall not be visible to unauthorized persons
5. We have the right to share your personal data with entities authorized under the applicable law (e.g. law enforcement authorities).
6. The length of the data storage period
1. Personal data will be processed for the period necessary to achieve the objectives referred to in paragraph 4 however, no longer than 10 years from the moment of consent to the processing of personal data, and after this period until the time of prescription of possible claims or until the expiry of the data storage obligations under the law.
2. We reserve the right to process your data after the end of the processing or withdrawal of consent only to the extent of the need to seek possible claims before the court or if national or EU regulations or international law oblige us to retain data.
7. Rights of persons providing data
1. In connection with the processing of your personal you have the right to:
- access to personal data;
- correcting of personal data;
- deletion of personal data;
- restrictions on the processing of personal data;
- object to the processing of personal data;
- transfer of personal data;
- lodging a complaint to the supervisory body.
8. Reporting objections to data processing
1. You may object to the processing of your data at any time.
2. An objection may be made as follows:
- by sending information to the e-mail address firstname.lastname@example.org.
- by sending information by post to the address of the registered office of the Company (Sokołowska 9/U-2, 01-142 Warsaw).
- by phone at 22 112 19 51.
- in person at the headquarters of the Company (BioResearch Group Ltd., Sokołowska 9/U-2, 01-142 Warsaw) or at the Clinical Research Center (BioResearch Group Ltd., Mokra 7, Kajetany, 05-830 Nadarzyn).
9. The right to submit a complaint to the supervisory body
1. If you believe that BioResearch, violates the provisions on the protection of personal data when processing of personal data, you have the right to lodge a complaint with the supervisory authority competent for your place of residence, place of work, the place where the alleged violation took place or any appropriate supervisory authority.
2. The Office of the General Inspector for Personal Data Protection, to which complaints can be lodged, is located in Warsaw at ul. Stawki 2.