Meet our potential
Monitoring, Research conducting, analyses, statistics, dedicated eCRF, support, safety
Complex research support Available on any platform, in compliance with: FDA Title 21 CFR Part 11
eCRF.bizTM system leaves traditional, paper documents aside (case report forms, profiles, etc.) created and gathered in the course of the research project. It allows to collect data remotely, data management as well as it includes an analytical module, which allows to monitor progress and generate project statistics.
Thanks to the implementation of the newest analytical solutions, it eliminates the risk of missing data in an effective way. This system contains an automatic record control component which supports the correctness verification process even at the stage of data implementation
Doctor/Researcher
- Contract signing
- Patients’ medical records documentation
- Dispensing of medicines
- Adverse events reporting
- Closing visits
Monitor/Statistician
- Real-time preview
- Making Queries
- Audit trail
- Validation (SDV and others)
- Export
Sponsor
- Real-time preview
- Data export
- Communication with users
- Reports
Distributor
- Access to the medicine database
- Distributing medicine among centres
- Drugs returns
- Forwarding trade planning
Research monitoring Real-time management
Access to the gathered information about patients.
Statistics of the data collected(summative charts, graphs).)
Research progress statistics (simple, dedicated).
Possibility of printing out the filled-in CRF forms.
Possibility of printing out AE/SAE forms, e.g. CIOMS.
Audit trail – Monitoring the changes in the values recorded.
Data query - Mechanism of querying.
Mailing - Sending e-mails about adverse events.
Drug Management Randomisation, distribution, dispense of medicines to patients
Randomisation
This module ensures an efficient and flexible process of patient randomisation which allows to define necessary functions in order to conduct a reliable clinical trial. This module is compliant with FDA standard: 21 CFR Part 11.
Properties
- Stratification of patients.
- Selection of randomisation methods (simple, block, biased coin).
- Blinding or unblocked options.
- Configuration of registration forms.
- Configuration of the criteria for inclusion and exclusion.
- Monitoring the status of randomness and the state of patients registration.
- Single- or multi-stage registration
- Randomisation after completing the last form / patient registration step.
- Managing the patients and monitoring the status
- Reports, verification and data export.
- Drug management module.
Drug management
The drug management module monitors the medical supplies among distribution centres, ensuring availability of proper resource in order to ration them to patients.
Properties
- Setting up the phial status (separately/collectively).
- Filtering the phials according to the status.
- Phials allocation to the centre chosen.
- Setting the medicine expiry date.
- Marking the lost phials with „lost” status.
- Monitoring the number of phials.
- Data export.
Online Contracting BioStat® implements new, electronic system of contracting with educators and researchers
Online contracts not only guarantee optimised and shortened process of contracting but also the utmost comfort and absolute safety. Thanks to online signing, we reduce the amount of needless printout as well as we avoid the necessity of sending documents via post or couriers. It speeds up the contracting process, reducing thereby the amount of time needed for the documents to be delivered as well as it improves the ways of accounting with the researchers or signing possible annex – in case of prolonging research.
The contracting process has never been so easy. All you need is to:
- Sign up - the user has to fill-in a registration form, thanks to which, our company may identify the person.
- Receive an e-mail sent to an e-mail address given during the registration and acquaint yourself with the content of the contract and statutes.
- Accept the contract conditions and statutes by clicking the right button.
Standardised and tested
Observational research with the use of eCRF.bizTM system is carried out in compliance with the guidelines included in Standard Operating Procedures.
Unlimited configuration options implemented in the intuitive interface and clear instructions
Authorial editor guarantees a number of options which facilitate creating forms in a quick and easy way. The creator allows to set conditions between queries, sites and particular fields by Drag&Drop option
Data safety The safety of our solutions is our highest priority
System security
- Access through an encrypted connection
- Protection against attacks such as SQL Injection
- Verification of any incoming data
- Use of transactions in order to keep data integrity
- Registration of any individuals accessing the system
- The access is granted only to authorised users directly connected with projects
Physical server security system
- Access to devices and servers is limited
- Every server room is connected to two independent electric and Internet lines
- Data backup is processed in real-time
- Switching to an auxiliary server is immediately processed through IP Failover
Logical security system
- Multilevel firewall system, detection and active intruders blocking systems (IDS/IPS), logical network partitioning (VLAN)
- Antyvirus systems
- Each of the users has got an unique ID and password
- Any attempts of unauthorised access are registered
- Constant monitoring and software updating
