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01 CRO 02 Clinical trials 03 Clinical trials of medicinal products 04 Clinical trials of medical devices 05 Observational studies 06 Medical Registers 07 eCRF
08 Data management 09 Real world data 10 Statistics 11 Trainings and consulting 12 Research and Development 13 Market Research

eCRF

Clinical Trial Software

  • check Clinical Trials
  • check Patient Medical Records
  • check Investigator Initiated Studies
  • check Observational studies
Compliant with FDA - Title 21 CFR Part 11
See functions
Active studies

We help you in development of "smart" eCRFs
and moving of your clinical trials into a digital world.

We offer a unique for the market multi-module electronic data capture (EDC) system - called eCRF.biz.TM, created for the scientific needs of the pharmaceutical and biotechnological industry. In designing it, we followed the FDA guidelines, resulting in compliance with Title 21 CFR Part 11 of the Code of Federal Regulations.

Friendly technology of electronic data capture (ECD) system - eCRF.bizTM, inspired
by Investigators, created for Professionals by Biostat Professionals.

The clinical data management system - eCRF.bizTM will allow you to easily and securely collect data, while a friendly interface will be appreciated by your Investigators. The eCRF.bizTM is an integrated research platform that completely eliminates need for paper clinical observational questionnaires, and lets us comprehensively manage entire studies. Electronic Case Report Forms (eCRFs) allow to obtain results much faster, and consequently allow for immediate review and analysis of data at each stage of the study.

Our clinical trial software - eCRF.bizTM system is used by a wide range of professionals and research centers, whose comments and suggestions provide valuable tips during constant development resulting in continuous improvement. By consulting with our customers, we can design and implement the best possible solutions for specific monocenter or multicenter studies, tailored specifically to your needs and suggestions from your recognized partners.

Use our system in following commercial and non-commercial studies:

Drug clinical trials

Medical device clinical trials

Cosmetic and dermocosmetic clinical trials

Bioequivalence studies

Investigator Initiated Studies

Our highly-qualified team have experience in development eCRF in the therapeutic areas like oncology, cardiology, alergology, dermatology, gastroenterology, psychiatry, ophtamology, neurology, etc.

All the time we are ready for new challenges.

Practical applications

Medical records
 
  • Collection of valuable epidemiological data – desirable from a scientific point of view
  • Data processing guaranteed to be compliant with the requirements of the Polish law
  • Increase in the efficiency of doctor's work
Observational studies
 
  • Single and multicenter studies
  • Non-interventional research that gathers scientific data and provides answers to research questions
  • Conducted in accordance with the principles of Evidence Based Medicine (EBM)
Clinical trials
 
  • Phase I-IV
  • Design and implementation of the study
  • Randomization, data management, monitoring and analysis
  • Statistical and epidemiological studies
  • Compliance with standard operating procedures (SOPs) and Good Clinical Practice (GCP)
Patient observation journal
 
  • Simple and useful tool in the hands of a doctor verifying compliance
  • Help in daily monitoring of various parameters in patients with chronic diseases
  • Registration of taken medication and the accompanying symptoms of illness or other lifestyle factors
  • Constant monitoring of patient's health
Market research
 
  • Create a new vision of the product/advertising/packaging, and a new communication concept
  • Reposition existing products
  • Provide knowledge and insight to enhance brand and product recognition
Advantages of BioStat electronic data capture (EDC) system - eCRF.bizTM.
  • Constant availability of your data 24/7
  • Faster and more efficient than paper CRF
  • Audit trial - full history of user activities in eCRF
  • Data queries management
  • Comments module - useful tool during eCRF development phase- each person involved in process can give tips directly within eCRF system
  • Randomisation and drug management module
  • Notifications/automated alerts (adverse event alerts, patient's status alerts (screened / randomized), kohorts opening and closing, e-mail alerts, etc.)
  • Customizable eCRF design
  • Online contracts signing between two parties
  • Access for everyone interested (e.g. Sponsor, Monitors, Medical Monitors, eCRF programmers, Data Manager, Investigated Medicinal Product suppliers, Investigators, etc.)
  • Dynamic reports (e.g. overall study progress, recruitment status, query report, adverse event listing, page/question verification report, etc.)
  • Printouts generation
  • Rapid transfer of data from external sources, lab integration
  • High security and data backup
  • Ongoing payment monitoring
  • Your new ideas....and our flexibility in creating new solutions
Short overview of BioStat service.
  • Preparation of eCRF validation documentation - Data Validation Plan, Validation Certificate, Data Validation Report, Data Validation Specification, etc.
  • Electronic Case Report Forms (eCRF) and eCRF completion quidelines for Investigator, Monitor, Annotated CRF, etc.
  • Randomization and Trial Supply Management - Interactive Web Response System (IWRS) , Interactive voice response system (IVRS)
  • User Acceptance Testing (UAT) - all system components are tested
  • Electronic patient reported outcome (ePRO) also commonly called Electronic patient dictionary
  • Central and local lab integration and data transfer from external devices
  • Data Management
  • Supervision of Adverse Events Reporting and Reconciliation
  • Preparing of well designed and clear landing page for your study (dedicated and prefered key visual)
  • eCRF trainings for Investigators (onsite and online)
  • Medical coding (based on MedDRA dictionary)
  • Statistical analysis and final statistical report
  • Phone and e-mail helpdesk

electronic Case Report Form (eCRF) development step by step.

Preparation
  • Designing the research – tool consultations and statistical analysis planning
  • Preparation of the electronic form – test and production versions
  • Randomization
Implementation
  • Signing contracts with participants of the study
  • Training the researchers
  • Data monitoring and management
  • Interim analyses
Conclusion
  • Closing the database and preparing it for the analysis process
  • Data analysis according to the statistical analysis plan (SAP)
  • Financial settlements with researchers
  • Preparation of the final report
Full clinical data management service for clinical trials and non-interventional studies.
  • Electronic Case Report Form (eCRF) development
  • Database structure design and development in accordance with CDASH standard
  • Ongoing data quality control, ensuring consistency and compliance with formal requirements
  • User account management
  • Edit checks Programming and Testing
  • Identification of missing data or incorrect values
  • Documentation - Data Management Plan, Data Quality Review Plan, Test Cases, Data Transfer Plan, etc.
  • Query management
  • Collaboration with international teams, ongoing communication with Sponsors, Monitors, Invastigators
  • Database cleaning
  • Database Lock
  • Training and consulting
Study success depends on excellence developed electronic case report form (eCRF) and data management service.
Choose the best electronic data capture system (EDC).
See functions
Real-time statisctics
 
Real-time statistics
Data queries
 
Data queries
Data validation
 
Data validation
Audit trail
 
Audit trail
Invitation and reminder sending
 
Invitation and reminder sending
Data Digital Transformation Monitoring in eCRF
Functions of electronic data capture (EDC) system.
eCRF.biz
Automatic reports
Comments
Online contracts
Audit trail
Data query
MedDRA dictionary
Randomization
Protocol deviation log
Notifications
Let us help you to create and manage your study in a rapid, traceable and efficient manner. Start your work with a powerful clinical data management system (eCRF.bizTM) and join the ranks our satisfied clients.
Contact us

Recommendations:

Amgen

Amgen
Amgen

„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.”

Military Medical

Military Medical
Military Medical

„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

Akademia Medyczna w Lublinie
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.

Mundipharma Polska Sp z o.o.
Mundipharma Polska Sp z o.o.
„The BioStat company performed their tasks professionally and always on time. The technical and logistic solutions always meet our substantial meetings and are intuitive for a system user. Any doubts or concerns are explained on an on-going basis without wasting time.”

Mabion

Mabion
Mabion
We have worked with BioStat company for over two years now and we mostly deal with clinical trials. They have created an e-CRF system that meets our research requirements as far as maintenance and system administration is concerned. The BioStat company perform their tasks reliably and in due time.

Clinic and the Cardiological and Non-invasive Cardiology Rehabilitation Centre

Clinic and the Cardiological and Non-invasive Cardiology Rehabilitation Centre
Clinic and the Cardiological and Non-invasive Cardiology Rehabilitation Centre
Quick, professional and on-time support in statistical analysis of the material needed for statutory work conducted by The Institute of Cardiology in Warszawa. It’s significant that the results were clear and comprehensible for anyone involved. I can recommend this company with complete conviction.

The Oncology Centre

The Oncology Centre
The Oncology Centre
The contractor’s task was to carry out a quantitative study on social opinion on the level of health awareness and health habits among specified target groups. The project “45+” in the field of genito-urinary diseases. The study was conducted without reservation and in accordance with the agreement signed.

Child Health Centre

Child Health Centre
Child Health Centre
In my opinion, the BioStat company is of high and proficient knowledge, basis of merit and most of all – we appreciate their availability. We could always be provided an explanation on unclear statistical knowledge. They always put the results in a comprehensible way needed to be implemented in clinical practice. We also strongly appreciate their graphic support. 

Central Institute For Labour Protection

Central Institute For Labour Protection
Central Institute For Labour Protection
This company conducted our survey research as well as the statistical analysis concerning risk assessment for handling portable computer equipment in a timely manner. The result met with our positive feedback.

The Institute of Occupational Medicine

The Institute of Occupational Medicine
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. 

ISN Pharma

ISN Pharma
ISN Pharma
„We have been using BioStat services for a long time as far as creating eCRF questionnaire for clinical trials is concerned or its handling, assumptions, documentation and research merit. The system created is very clear and user friendly.”

Wroclaw Medical University

Wroclaw Medical University
Wroclaw Medical University
„I am highly satisfied with their professional and on-time statistical data analysis which is significant while composing a PhD thesis. What deserves credit is their high proficiency level, as well as flexibility in meeting customers’ needs.”  

Novartis Poland Sp. z o.o.

Novartis Poland Sp. z o.o.
Novartis Poland Sp. z o.o.
„The cooperation with BioStat was smooth. The company always prepares all elements of the agreements on time, with no delays. The contacts with BioStat were always very professional and the quality of their work was very high.”

The Institute of Psychiatry and Neurology in Warsaw

The Institute of Psychiatry and Neurology in Warsaw
The Institute of Psychiatry and Neurology in Warsaw
The statistical analysis referring to multiple judicial-psychiatric-psychological opinion-giving was conducted uncritically and in accordance with the agreement.

The Clinic and Department of Orthopaedics and Traumatology at the Medical University of Lublin

The Clinic and Department of Orthopaedics and Traumatology at the Medical University of Lublin
The Clinic and Department of Orthopaedics and Traumatology at the Medical University of Lublin
The BioStat team proved themselves in being proficient at medical issues. They were a party to the statistical research methodology design, dealt with calculations as well as they verified other researchers’ results.

National Veterinary Research Institute

National Veterinary Research Institute
National Veterinary Research Institute
The contractor consulted their e-database components with us to meet the ordering server requirements what allowed us to continue the research in the following years. The e-monitoring program was designed conscientiously and professionally. 

Pfizer Polska Sp. z o.o.

Pfizer Polska Sp. z o.o.
Pfizer Polska Sp. z o.o.
„We received an excellent support in the area of statistics, data analysis and the use of advance in medical research projects. The BioStat company used a very clear language and a variety of methods to maximize our understanding and to ensure that statistical theory and practice were integrated.”

The Institute of Haematology and Transfusion Medicine

The Institute of Haematology and Transfusion Medicine
The Institute of Haematology and Transfusion Medicine
„The research results provided by BioStat company are promising, especially that there is a small number of such research done on clinical application. The results have been presented during some national and international conventions on haematology and haematopoietic stem cell transplant. Our collaboration is brilliant. We are in permanent contact and we are hoping for further fruitful and professional cooperation.”

Medical University of Warsaw

Medical University of Warsaw
Medical University of Warsaw

During our collaboration, the company fulfilled its duties professionally and diligently. The company's employees are perceived by us as reliable professionals who are fully committed to their work. Throughout our cooperation, they demonstrated understanding and patience in adapting to project changes.

Helimed

Helimed
Helimed

We worked with BioStat to survey the quality of service and patient feedback in our facilities. The service was performed carefully and in accordance with the terms of the contract.

Celon Pharma

Celon Pharma
Celon Pharma
„We have used services of Rafal Piszczek (from BioStat company) since 2006 in the scope of medical statistics. During our cooperation, Rafal Piszczek has performed his services in a professional way. We are indeed thankful for his reliability and recommend him as a professional statistician.”

Johnson & Johnson Poland

Johnson & Johnson Poland
Johnson & Johnson Poland
„In 2015, the BioStat company designed a statistical analysis for Johnson & Johnson (LifeScan) research project. We consider collaboration as positive. The tasks were completed reliably and in a timely manner. I recommend their professional service and timeliness.”
 

Domański Zakrzewski Palinka

Domański Zakrzewski Palinka
Domański Zakrzewski Palinka
„Within the job commissioned, we asked your company for an analysis of the price level for a medicinal product concerning the competitive price. The task was carried out diligently, conscientiously and in a complex way.”

Lek Polska Sp z o.o.

Lek Polska Sp z o.o.
Lek Polska Sp z o.o.
„During our cooperation, BioStat company perform their service in a professional way, upright and keeping deadlines as well the quality of service was on a very high level. BioStat company approach to our order in special individual way and execution of the project meets our expectations. While the contact and cooperate with BioStat, we meet with kind, on time and flexible treatment.”

MSD

MSD
MSD
„Reaching ambitious goals is possible thanks to our business partners professional support. We consider BioStat company as one of our recommendable partners. In the period 2007-2008 BioStat designed three research projects for MSC Polska on the basis of in-depth interviews (IDI). The projects were carried out correctly, on target and with a complete engagement of their team members.”

Institute of Economics, Polish Academy of Sciences

Institute of Economics, Polish Academy of Sciences
Institute of Economics, Polish Academy of Sciences
„The statistical analysis of the data and study on the econometric model within the research project entitled ‘Development paradigm and the effectiveness of innovative structural aid from the EU’ was carried out very conscientiously. The quality and timeliness provided within this taskdemonstrate extremely high competencies and professionalism of the BioStat team.”

Thea Polska Sp. z o.o.

Thea Polska Sp. z o.o.
Thea Polska Sp. z o.o.

We recommend BioStat in the implementation of quantitative and qualitative segmentation studies and broadly undertaken marketing research. The cooperation to date has been successful and flawless. The company has provided expert advice and full professionalism in the provision of research services. In addition, BioStat's staff stood out for their high level of knowledge and competence. It should also be emphasised that BioStat was very flexible in planning and proposing solutions, which is highly appreciated in this day and age.

Chiesi

Chiesi
Chiesi
„Regardless any on-going research, the BioStat company, by so far, has carried out for us a dozen statistical analyses basing on the data we gathered from other research. Each of the analysis commissioned was carried out quickly and firmly. Currently, BioStat is our preferable statistical service provider. Their company is definitely recommendable.”

Novascon Pharmaceuticals Sp z o.o.

Novascon Pharmaceuticals Sp z o.o.
Novascon Pharmaceuticals Sp z o.o.
„The BioStat company has again demonstrated high responsiveness towards the client’s needs, working hours beyond the standards if the situation so required and flexibility concerning results presentation that was needed at any given moment. Their engagement in unexceptionable contact with clients as well as the scope of their knowledge gives the client a sense of being in good hands.”

Medtronic

Medtronic
Medtronic
„What is extremely valuable in modern market conditions is to find adequate companies to collaborate with, that would know our needs, and sometimes, they would even use their experience and professionalism to provide support in issues which we are not quite familiar with. We are pleased to recommend the services that BioStat provides especially to these companies that are trying to find a solid business partner to collaborate with. We are convinced that you can count on them. We consider BioStat as a professional company with wide experience, that ensures continuous cooperation and development for their business partners.”

Medical University in Lublin

Medical University in Lublin
Medical University in Lublin
„In late 2011, the BioStat company carried out a study concerning the attitudes towards genetic information and biobanking on behalf of the Faculty of Humanities at the Medical University in Lublin within the scientific grant given to dr. Jakub Pawlikowski by MNiSW. I confirm that the company has carried out the task reliably and in a timely manner, demonstrating professionalism at the same time and providing a complete research report along with the statistical analysis.”

The University of Lodz

The University of Lodz
The University of Lodz
„I confirm that the BioStat company carried out the research within a project entitled: “The role, position and scope of functioning of Staff Committees in Polish employment relationship system”. The service provided was conducted in accordance with the schedule set in the agreement along with due diligence, professionalism and engagement. As far as the current collaboration with BioStat is concerned, it needs to be said that their company is highly recommendable.”

SGH Warsaw School of Economics

SGH Warsaw School of Economics
SGH Warsaw School of Economics

BioStat undertook a qualitative study on the measurement of human capital in Polish companies, together with transcriptions and preparation of the study report. The subject of the contract was performed in accordance with the provisions of the contract and with due diligence.

Military Medical Institute

Military Medical Institute
Military Medical Institute
„On behalf of the Department of Marine and Hyperbaric Medicine at the Military Medical Institute, I am pleased to give references to BioStat company, that in a professional way took up the task for designing an advanced tool using the rules of Bayes statistics (…). The project was conducted in a timely manner and the collaboration was smooth, without any problems.”

Milton Essex

Milton Essex
Milton Essex
„The quality of IT solutions provided by BioStat exceeds the majority of alternative eCRF systems as far as their functionality and safety are concerned. I express recognition for the terminable and professional organisation of any task commissioned. We recommend the BioStat company services to all entities working in the R&D sector.”

Military Medical

Military Medical
Military Medical
„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.”

Medical University in Lublin

Medical University in Lublin
Medical University in Lublin
„I have known 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 statistics.”

EGIS

EGIS
EGIS
„The BioStat company provides professional support and services. The BioStat team members have essential knowledge and competencies, as well as they exhibit openness and readiness towards solving problems or any doubts.”

Amgen

Amgen
Amgen
„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 doing his duties as well as for his creative contribution on the projects being conducted by Amgen.”

The clinic and Department of Urology and Urological Oncology

The clinic and Department of Urology and Urological Oncology
The clinic and Department of Urology and Urological Oncology
„The BioStat company was helpful in working out the statistical data for a rarely discussed topic in literature that is anabolic substances abuse. The data compilation allowed us to publish some works in leading medical magazines or present the issue at the Scientific Congress of Polish Urological Society.”
More recommendations
eCRF functions
CRO
Clinical trials
Drug clinical trials
Medical device clinical trials
Non-commercial clinical trials
Observational studies
Pharmaceutical market research
Research and development
Medical registers
eCRF
Statistics
Biostatistics
Data management
Trainings and consulting
Monitoring
Real-World Data
Digitization of the data collection process
Offer pdf

Frequently asked questions.

Is a license necessary to purchase your eCRF system?
No. As Biostat® is the author and owner of the software, a separate/external license purchase is not required. We typically sell the eCRF system under a study implementation service model using our own system. If a client is interested in purchasing a license for our system, we approach the pricing and sale of the eCRF service individually based on that business model.
 
What is the lead time for setting up the eCRF.biz™ system for an observational study?
The waiting time for creating a configured eCRF.biz™ system tailored to a specific observational study is always adjusted to the client's expectations. However, the average time ranges from 21 days to 1 month.
 
Does the eCRF.biz™ system allow for report generation?
The eCRF.biz™ system has been enhanced with reporting functionality based on the open-source statistical package R. Integrating this software with eCRF.biz™ enriches the conducted studies with automatically generated reports of varying complexity levels. Reports can be in the form of PDF files or web pages and can include tables, charts, and updates on study progress.
 
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