eCRF | Statistics | Data Management
Comprehensive services for interventional, clinical studies (phase I-IV).
BioStat® is a high quality provider of services to the pharmaceutical, biotechnology and medical device industries, specializing in commercial and non-commercial clinical trials - phase I-IV.
BioStat® has been ensuring clients achieve their clinical research goals for over 15 years. As experts in the managing, planning, data processing, data management and statistical services we deliver each clinical trials on time. Our activities meet local and international law requirements, Good Clinical Practice (GCP) and BioStat' s and Sponsor's Standard Operating Procedures (SOPs). We understand how important is time, costs and quality, and are able to guarantee these metrics are met. BioStat® offers a comprehensive portfolio of services which can be tailored to meet the individual needs of each client.
Learn more about our services:
- Clinical Trials of Investigational Medicinal Products
- Clinical Trials of Medical Devices
- Bioequivalence Studies
- Investigator Initiated Studies
- Clinical Trials of Cosmetics and Dermocosmetics
We are an efficient team able to conduct English-language studies in Poland and abroad. We have a wide range of experience in following therapeutic fields, including oncology, invasive cardiology, allergology, dermatology, gastroenterology, psychiatry, ophthalmology, neurology, etc. We are ready for new challenges all the time.
All clinical trials are conducted by using a huge potential and capabilities of our proprietary eCRF.bizTM system that allows for electronic data collection and efficient management of the process.
- Study design in collaboration with Key Opinion Leaders (hypothesis, sample size calculation, publications review, etc.)
- Comprehensive statistical services (Statistical Analysis Plan (SAP), tables, listings, statistical section in study protocol, interim analysis, final statistical reports, final data presentation, support in CSR preparation)
- Preparation and consultation of study documentation
- Negotiations and contracting of Sites and Investigators
- Cooperation with Ethics committee and National Regulatory Authority
- eCRF preparation (database creation and programming)
- Preparation of an electronic diary of patient observation (PRO)
- Interactive Web Response System (IWRS)
- Drug Management System
- Integration with local and central laboratories
- Data Management - database structure development, edit checks, user account management, quality control of entered data, database cleaning and closing
- Supervision over reporting of adverse events
- Simple Landing Pages in a dedicated key visual
- Medical coding (according to the MedDRA dictionary)
- Helpdesk - phone and email
- Assistance in the preparation of the scientific publications or articles
- Support for Key Opinion Leaders in preparation of the study results presentation at congresses and scientific conferences.
There are many high-qualified experts and specialists such as project managers, biotechnologists, biologists, statisticians, biostatisticians, and data managers, etc. Their analysis meet the Master Journal List standards.