and observational studies
- eCRF/Data management
- Study design, statistical service (developing hypothesis, selecting a sample size, statistical section in the protocol)
- Cooperation with external experts and Key Opinion Leaders
- Preparation and / or consultation of study documentation (e.g. study protocol, protocol summary, observation questionnaire, patient information, informed consent form, communication plan, study monitoring plan, study management plan, data management plan, statistical analysis plan, etc.)
- Documentation of clinical studies submitted to regulatory agencies in Poland (URPL, bioethics committee)
- Negotiating and contracting investigators centers and investigators (one/multi-party agreements)
- eCRF system, start pages, database, validation, instructions
- Electronic case report form for patients
- Randomization - construction of a randomization system, creation of randomization lists, drug distribution management system
- Integration with laboratories
- Documentation printout for investigators and patients
- Stationary and online training, video conferences, teleconferences
- Project management
- Site initiation, monitoring and close-out visits (CRO)
- Project meetings
- Reporting and monitoring
- Study monitor`s supervision
- Adverse events reporting management
- Data management (data quality control, database cleaning, user account management, etc.)
- Statistical analyses - interim analysis, tables, listings
- Financial management (investigators, study centers etc.)
- Project management
- Helpdesk (phone, e-mail)
- Server maintenance and hosting
- Payment processing (investigators, study centers etc.)
- Final statistical analyses - tables, listings
- Final statistical report
- Cleaning and closing the database
- Medical coding (according to the Meddra dictionary)
- Archiving data and documents
- Assistance in preparing CSR, scientific publications or articles
„The cooperation has concerned survey organization, consulting and statistical analysis of quantitative research. We are indeed thankful to Rafal Piszczek for his reliability and professionalism in ding his duties as well as for his creative contribution on the projects being conducted by Amgen.”
„I confirm that I have dealt with Mr Rafal Piszczek since 2006, during which time he has provided us with excellent support in the area of medical data analysis and the use of advanced statistical tools. I can confidently recommend Mr Rafal Piszczek as a solid and reliable expert in this field.”
Akademia Medyczna w Lublinie
„I have know and collaborated with Rafal Piszczek, member of our research team, since January 2005. I am absolutely convinced, Rafal Piszczek is a very good candidate for any responsible work in the area of statisties.”
Mundipharma Polska Sp z o.o.
Clinic and the Cardiological and Non-invasive Cardiology Rehabilitation Centre
The Oncology Centre
Child Health Centre
Central Institute For Labour Protection
The Institute of Occupational Medicine
This company carried out Polish nationwide survey research . We consider their work as reliable and on-time as well as in accordance with the agreement. Additionally, we do not raise any objections to the materials presented.
Wroclaw Medical University
Novartis Poland Sp. z o.o.
The Institute of Psychiatry and Neurology in Warszawa
The Clinic and Department of Orthopaedics and Traumatology at the Medical University of Lublin
National Veterinary Research Institute
Pfizer Polska Sp. z o.o.
The Institute of Haematology and Transfusion Medicine
Medical University of Warsaw
Johnson & Johnson Poland
Domański Zakrzewski Palinka
Lek Polska Sp z o.o.
Institute of Economics, Polish Academy of Sciences
Thea Polska Sp. z o.o.
Novascon Pharmaceuticals Sp z o.o.
Medical University in Lublin
The University of Lodz
SGH Warsaw School of Economics
Military Medical Institute
Medical University in Lublin
The clinic and Department of Urology and Urological Oncology
Frequently asked questions.
Yes, we provide comprehensive support in statistics. Its scope includes research design, i.e. sample size calculation, justification, statistical input at the protocol and Statistical Analysis Plan. At the research stage, we are responsible for database construction, transitional analyses, statistical analyses, statistical reports, support in the creation of CSR, publications and articles, and big data analyses. We perform statistical analysis in accordance with the requirements of ISI Master Journal List, known in Poland as Philadelphia List.
Yes, we can prepare a randomisation system (Interactive Web Response System, IWRS) for a clinical trial in a form of a separate system or a module integrated with the eCRF system. Furthermore, we are responsible for the preparation and implementation of the randomisation list. The IWRS system complies with the FDA 21 CFR Part 11 standard and enables the randomisation of patients according to the established algorithm and the management of key aspects of clinical trials such as registration, randomisation, dosing, drug dispensing, clinical procurement, drug inventory management, unblinding, etc.
Yes. We conduct research in both paper and electronic versions. The vast majority (approx. 97%) are studies conducted in electronic form based on the proprietary eCRF.biz system (an integrated research platform that completely eliminates paper clinical observation questionnaires and allows us to comprehensively manage the entire research project). Electronic CRF (eCRF) enables much faster acquisition of results, and therefore immediate data analysis at every stage of the study. Nevertheless, we have all the resources that also allow us to organize a paper survey.
We have the resources and knowledge to conduct research in any field. We have the greatest experience in therapeutic areas such as oncology, gastroenterology, transplantology, cardiology, neurology, allergology, psychiatry, neonatology, diabetology, pulmonology, immunology, andrology, proctology, dermatology, ophthalmology, rheumatology, virology and hematology.
Yes. Biostat® provides contracting services for centers and investigators in clinical and observational studies. We negotiate bilateral, tripartite and quadrilateral agreements. We conclude tripartite and quadrilateral contracts in traditional paper form. In the case of bilateral contracts, we use the eCRF.biz ™ system function to conclude contracts online, which eliminates the need to print, scan and send documents via courier. We are also responsible for the financial and accounting settlement process.