from seamless integration between our products.
Payments, Queries, Documents,
Documents, Signaturs, Security,
Quality Check, IPR - Invesicational
Form, Connection, Vacation,
Monitoring, Verification, Quality
CLOUD AND OFFLINE SAFE
Files are synchronised constantly over the cloud when connected to internet. At the same time files are always accessible through offline copies stored at hard drive of the computer. Files are kept safe during transfer and storage.
With the application the costs related to printing, shipping, storage and on-site verification get minimised. Navigation and organization of the files are intuitive and much more convenient than paper-based standard.
Upon application set-up for a project the Client can decide on files structure, its naming and access types. This system allows flexibility even in the highest level of detail (ultimate subfolder - individual user).
REQUIREMENTS AND STANDARDS
Application contains all components, controls and policies for eTMF and eISF that are required according with US FDA CFR 21 part 11, EU Annex 11 and Good Clinical Practice. TMF Reference Model version 3.0 was followed to create standard structures of eTMF and eISF.
DO IT IN-HOUSE
By using this application majority of the document flow between Sponsor and Site is based on the upload and send features of the application, reducing the need to verify paper files at sites.
DUE DILLIGENCE AND OVERSIGHT
Set-up of application allows remote control of eISF content and makes the updates between Sponsor and Site to be real time. The actions feature allows to generate customisable reports and set-up quality checks according to Client's procedures.
CONVENIENT FOR CRA
Manual data entry to visit reports is reduced to minimum as recorded from site status tab can be easily picked. Letters to sites associated with visit are drafted and auto-populated with data from visit report and site status tab.
Templates of visit reports, confirmation and follow-up letters, project plan are uploaded or created in application for each project. Visit reports can be accompanied with annotations or tips that smooth process of report submission and approval.
Each registered user has ability to place electronic sigature within application. This solution is applied to visit reports as well as document management tab.
MILESTONES AND DASHBOARDS
First source to find, review or present progress of your project. Site status tab can import patient's data from eCRF including enrolement, visit and consent dates, Adverse Events or Protocol Deviations. Merge that with data generated in CTMS (CRA Calendars, Vsiti Reports, Action Items) to create your own reports and dashboards.
This solution allows to create, turnaround and finalise documents within application. You can involve users from different organizations in joint work on templates, logs, annotations or plans and not get lost in emails and working versions.
Application allows to set up and manage effectively grant payments of your project. Integration between clinical trial agreements, budgets and eCRF allows to process smoothly this important feature of the project.
This application is compliant with FDA Guidelines (Title 21 CFR Part 11), standard operating procedures (SOPs) and Good Clinical Practice (GCP) being an ideal tool for pharmaceutical, biotechnology and device industry. This EDC allows safety reporting to Sponsors and can also support creation of reports for Competent Authorities.
Randomization module allows to program patients allocation according to study protocol and integrate Investigational Product delivery and inventory into one application with EDC. Enablement of IXRS module creates coherent platform to control study enrolment and manage accountability of study treatment.
Encrypted connections, automated backups and advanced audit trail create safe tool to collect and store clinical trial data. Database is secured for unauthorized access and kept on dedicated servers. Throughout years of usage it became a trusted tool for many sponsors and investigators.
CLEAN & SIMPLE INTERFACE
Intuitive interface and easy to use forms of this system can be accessed from anywhere in the world, at any point in time, using your Internet browser. Technology employed into the EDC assures seamless performance what is being appreciated by sites and sponsors using this application.
eCRF is equipped with automated validation of accuracy and completeness of entries. It allows to set-up checks that minimize time to reveal error. Our experienced Team of Data Managers, Biostatisticians and Programmers create smart, analytical and automated EDC that reduce redundant work for ultimate users.
This application can include secure access for clinical trial patients for their direct data entry that creates a unique platform integrating electronic Patient-Reported Outcomes (ePRO) into EDC. This solution can completely eliminate need of maintenance of separate tool for handling patients' diaries and questionnaires bringing data together in one place.
Trialscape applications are modern electronic tools for collection, processing and storage of clinical trial data. Cloud based environment is designed to allow easy access and to meet all regulatory requirements. With web based access data are available in rael-time increasing flow of information and oversight of the project.
Setup of Trialscape applications allows configuration according to the client's SOPs and protocol design. Trialscape applications have modular structure and each module can be individually switched on and customized according to the project needs. This way each study can get most individual and fitting tools to successfully manage it.
Biostat® - a rapidly developing company that connects the dots between a research agency, a CRO and a Software House. Throughout the last 14 years we have been delivering professional solutions within the areas of research, IT, medical statistics and consultations - all to key pharmaceutical companies.
Smart.Kestrel - a startup company focused on development and integration of eclinical solutions. Smart.Kestrel aims to create best in class tools, designed to smoothly run clinical trials.