First fully integrated
eTMF / eISF solution

Designed by Kestrel and BioStat specifically for the eClinical market, this novel solution brings together electronic Trial Master Files (eTMF) with electronic Investigator Site Files (eISF), integrating their features into a single system.

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When you need to know
CTMS everything about your project

Our CTMS is available online and offline with an integrated background synchronization system. The application allows you to easily access and use the most recent data, and to write visit reports at any time, any place. Our document creation engine makes it simple to prepare reports and dashboards using your patients' data imported from the eCRF, write and finalise visit reports, and manage grant payments as well.

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eCRF.biz™
Modern data collection system for clinical and observational studies

BioStat offers a modular eCRF system, made specifically to cater to the scientific needs of the pharmaceutical sector. eCRF.biz.pllTM enables you to make the move to electronic forms easily and safely.

learn more

First fully integrated
eTMF / eISF solution

Designed by Kestrel and BioStat® specifically for the eClinical market, this novel solution brings together electronic Trial Master Files (eTMF) with electronic Investigator Site Files (eISF), integrating their features into a single system.

Safety, both online and offline

Files are synchronized constantly over the cloud when connected to the Internet, while at the same time being accessible through offline copies stored at the computer’s hard drive. This way, files are kept safe during both transfer and storage.

Complete control and oversight

The set-up of SMART.KESTREL allows for remote control of eISF content and allows for real-time updates between the Sponsor and site files. The actions feature provides an option to generate customizable reports and set-up quality checks according to Client's procedures.

Compliant with all of the regulatory requirements

SMART.KESTREL contains all components, controls and policies for eTMF and eISF that are required according to: US FDA CFR 21 part 11, EU Annex 11 and Good Clinical Practice. The application has native support for health authority inspections, proving its ability to ensure records retention.

In line with industry standards

TMF Reference model version 3.0 was followed in order to provide standardized eTMF and eISF structures.

Cost effective

With the SMART.KESTREL the costs related to printing, shipping, storage and on-site verification get minimised. In addition this application can include other features: Essential Documents review and distribution of safety reports.

Fully customizable

During the software’s setup, the Client can decide on the structure of the files, their naming and access types. This system allows flexibility even in the highest level of detail (ultimate subfolder - individual user)

Do it in-house

By using SMART.KESTREL majority of the document flow between Sponsor and Site is based on the upload and send features of the program, reducing the need to verify paper files at sites.

Ease of use

SMART.KESTREL is an easy and handy system to use. Both navigation and organization of the files are intuitive and much more convenient than paper-based standards.

When you need to know
CTMS everything about your project

Our CTMS is available online and offline with an integrated background synchronization system. The application allows you to easily access and use the most recent data, and to write visit reports at any time, any place. Our document creation engine makes it simple to prepare reports and dashboards using your patients' data imported from the eCRF, write and finalise visit reports, and manage grant payments as well.

Convenient for CRA
Manual data entry when writing visit reports is reduced to a minimum, as records can easily be picked from the site status' tab. Letters to sites are automatically drafted, and filled with data from the visit report and the site status tab.
Electronic signatures
Pach registered user has the ability to place his or hers electronic signature within the application. This solution is applied to visit reports and to the document management tab.
Monitoring Tools
Templates of visit reports, confirmation and follow-up letters, as well as project plans are all created within the application, and uploaded for each project. Visit reports can have attachements such as annotations and tips that smooth out the process of submitting reports for approval.
Document management
This solution allows you to create, turnaround and finalise all documents from within the application. You can involve users from different organizations in joint work on templates, logs, annotations or plans, and not get lost in a mountain of emails and working versions.
Grant payments
You can effectively set up and manage grant payments for your project. Integration between clinical trial agreements, budgets and eCRF allows you to smoothly process this important part of every project.
Integration cloud
Our CTMS is integrated through cloud with other applications, and allows you to import your data right from eCRF, or to transfer files directly to – or from – eTMF and eISF, using MyTasks.
Milestones and Dashboards
Our CTMS is your first source to find, review and present the progress of your projects. Site status tabs can import your patients' data from the eCRF, including enrloment, visits and consent dates. Adverse Events and Protocol Deviations can be merge with data generated by the CTMS (CRA Calendars, Visit Reports, Action Items) to create your own reports and dashboards in a form that is usefull to you and your Project Team.

eCRF.biz™
A modern data collection system for clinical and observational studies.

BioStat® offers a unique, modular eCRF.biz.pl™ system, made to cater to the scientific needs of the pharmaceutical sector. eCRF.biz.pl™ allows you to completely eliminate paper case report forms, enabling you to move your data into an electrical form safely and securely.

Main features
  • Compliance with FDA Guidelines (Title 21 CFR Part 11)
  • Statistics for collected data and research process
  • Ability to print AE / SAE (e.g. CIOMS) and CRF forms
  • Internal messaging system
  • Double Data Entry
  • Exports the data to popular formats
  • Limited access – patients and researchers get access to assigned centers only
  • Compliance with standard operating procedures (SOPs) and Good Clinical Practice (GCP)
Security
Encrypted connections allow for administrative access
Automated backups, created daily for maximum safety
Data entries are validated automatically
Security
Technology
Clean & simple interface
System can be accessed from anywhere in the world, at any point in time
All functions available from your Internet browser
Technology
Practical Applications
Clinical trials
Observational studies
Medical records
Patient observation journal
Market research
Practical Applications

eCRF.biz.pl™ is used by a wide variety of specialists and scientific centers, all of which help improve the software by asking questions and providing suggestions. Thanks to our users we can constantly work on designing and implementing solutions that are perfect for specific purposes.

Any questions? We're happy to help!
Write to us at biuro@biostat.com.pl