- eCRF/Data management
Non-Commercial Clinical Trials
- aim and benefits.
- Development of clinical knowledge and practice as well as quality of medical care for patients and standards` improvement of their treatment.
- Analysis of the effectiveness of approved medicines in different patient populations or in indications other than the original one.
- An important factor in progress of knowledge in medical sciences.
- Access to modern and innovative therapies for patients suffering from rare diseases.
- Raising the qualifications and position of investigators and young scientists.
Sponsorship in non-commercial clinical trials:
- Healthcare center
- A university or other investigation institution with the right to confer academic degrees
- Investigator (so-called 'IIS' study - investigator initiated study
- Investigators organization / patient organization
- Natural / legal person or organizational unit without legal personality
- Study design, statistical service (developing hypothesis, selecting a sample size, statistical section in the protocol)
- Cooperation witk 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)
- Comprehensive project management
- Communication managemnet between investigators and investigators centres
- 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
- Site initiation, monitoring and close-out visits (CRO)
- Monitoring and reporting
- Study monitor`s supervision
- Reporting of adverse events
- Data management (data quality control, database cleaning, user account management, etc.)
- Statistical analyses - interim analysis, tables, listings
- Financial management (investigators, study centers etc.)
- Comprehensive project management, - project meetings
- 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 (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
"If the owner of the data obtained during a clinical trial is a sponsor, university, ... or other scientific institution, (...) a therapeutic agent, ... a researcher, a patient organization, an investigator organization or another natural person ... the clinical trial is a study Clinical non-commercial."
Pharmaceutical law, Article 37a
Frequently asked questions.