Document Management System for the pharmaceutical industry

SMARTKESTREL is a cloud based environment that equips your study with modern technology.

Fully integrated
eTMF-eISF solution

SMARTKESTREL is a novel application for the eClinical Solutions market, integrating features from electronic Trial Master File (eTMF) and electronic Investigator Site File (eISF) into one system.

Explore benefits and advantages

Manage your files

Navigation through the dashboard interface is intuitive and easy. Keep your eTMF and eISF up-to-date by using our browser-based software or desktop application.

Generate reports

Customise reports to your needs and control study progress. Cloud service is used to give you full access to your data anywhere in the world.

Communicate within
the application

Send and receive tasks, set tasks' priorities, obtain the document quicker from the sponsor, CRO and investigator and file it automatically in the selected folder of your eTMF and eISF.

Main features

Stay cloud and offline safe

Files are synchronised constantly over the cloud when connected to the internet, while remaining accessible at all times through offline copies stored on the hard drive of the computer. Files are kept safe during transfer and storage.

Cut costs

With SMARTKESTREL costs related to printing, shipping, storage and on-site verification are minimised.

Customize to your needs

Upon application set-up for a project the Client can decide on files structure, naming and access types. The system is highly configurable and allows flexibility all the way to the very last subfolder or individual user.

Stay compliant with legislation

The application contains all components, controls and policies for eTMF and eISF that are required in accordance with US FDA 21 CFR 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.

Control content quality

The set-up of the application allows remote control of eISF content and enables real-time updates. The actions feature allows the user to generate customizable reports and set up quality checks according to the Client’s Quality Control procedures.

Do it in-house

From study set-up, through regulatory documents collection and study maintenance to close-out, SMARTKESTREL allows you to work with sites and vendors remotely in a fully electronic environment. Take advantage of the immediate benefits of paperless efficiency throughout the whole study.

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Let me know when
SMARTKESTREL is launched

Reach your sites all over the world

Exchange documents and stay in touch with all your sites in the study across the world… with no limits.

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