trialwiseSCAN 

Rapid Document Transfer for eTMF

We believe that 21 CFR Part 11 compliance need not mean slow & cumbersome.

Get paperwork off desks and into the correct file, reduce time spent collecting site essential documents and improve TMF audit readiness. trialwiseSCAN enables regulatory documents to be scanned and filenames and indexes applied in just a few keystrokes.

Trialwise Pty Ltd is proudly Australian owned. Our systems are 21 CFR Part 11 compliant. Each and every release of trialwiseSCAN is internally validated. For privacy and security, all scanned documents are handled on-device, secured by biometric login, accessible only by users and protected from phone and cloud backups.

trialwiseSCAN is ready to use directly from the AppStore (complete with default settings for indexing and file-naming).  Try it out today. 

Flexible options are available for teams and corporates.  Study and company specific eTMF indexes and file-naming standards can be readily set-up and deployed to project teams, specified individuals or enterprise wide. MDM options are also available. 

“A must have app for anyone wanting to streamline regulatory document collection, improve traceability, reduce lost and misfiled documents and stay audit ready.”

Improve eTMF Quality & Timeliness 

Improve Quality

Standardise document naming and application of metadata, minimize typographical errors and improve file consistency and timeliness.

File Consistency

Reduce file indexing errors, employ and enforce indexing updates and keep your eTMF consistent, up to date and audit ready

Save Time

Streamline document capture, indexing and submission to the eTMF, its that simple.

Fast and Efficient

Capture, process and send fully indexed documents from site to eTMF in just a few taps

Reduce Costs

Stop double handling, cut printing and courier costs and deliver on both quality & cost effectiveness

Lower Costs

Make your process more efficient and save on document administration and handling costs, as well as scanning vendors, couriers, equipment and paper.

Secure

Documents and data are secured in-app using biometric login and never backed up to the cloud. All done on-device with no external servers required.

Confidentiality is Important

Your documents and any data you enter are processed and stored locally on your device, protected by biometric login.

GCP Compliant

Meets compliance with 21 CRF part 11 requirements

Validated Process

Accurate, reliable and consistent processes to assure the authenticity of your digitized documents. Ask us how.

Configurable

Determine the level of control you need individually or across an enterprise

Enterprise Solutions

Ask us about the options for small, medium and large enterprises. We can scale up or down based on your needs.

Simply Scan, Index & Submit

 

1. Scan

trialwiseSCAN uses leading edge technology to detect, capture and crop pages automatically so you can quickly achieve quality images with all the attributes of the original. DPI settings can be dialled up or down according to the needs of your project. Move pages around, re-crop, rotate and add or delete pages as needed.

2. Name & Index

Add standardised filenames and metadata and determine the correct file location (index) simply and automatically at the point of collection and reduce the rate of misspelt and lost or misfiled documents. The DIA TMF reference Model 3.1.0 and a standardized naming convention are used by default, however enterprise and project level TMF templates, EDLs and naming conventions can also be quickly and easily deployed and managed. Ask us today about options for managing deployment with Managed Files and trialwiseSCAN Enterprise.

3. Submit

Submit as a pdf by email to your eTMF mailbox or document management team for QC review. Ask about trialwiseSCAN Enterprise for options to submit direct to your eTMF via secure API. trialwiseSCAN is Vendor agnostic, so you can use one app for all your projects.

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