CRFTrackCUT TIME AND COST

Get your CRF lifecycle on the

right track, with the most power­

ful and flexible PDF conversion and formatting

tool available

Seamlessly manage case report forms with CRFTrack’s 200-plus powerful templates As the clinical development lifecycle becomes more complex in today’s regula­tory environment, it is now more critical than ever to take advantage of integrated solutions that increase the speed and quality of the clinical trial process.

One key area to be addressed is Case Report Forms (CRFs) and associated clinical documents — one of the most paper-intensive document processes in the life sciences industry. With clinical trials generating millions of pages of paper documents, there is increasing pressure to adopt technologies that optimize and accelerate drug development.

CRFTrack is a fully scalable, enterprise system that processes paper CRFs into an electronic format and then publishes and maintains them in a fully 21 CFR Part 11-compliant environment. CRFTrack captures, processes, tracks, and prepares clinical documents, including CRFs, data correction/clarification forms, lab/ECG reports, patient diary cards, and adverse event listings. Once scanned, these documents are then processed as an image throughout the clinical process.

With CRFTrack: • You’ll reduce time and costs during

clinical trials and while preparing for electronic submissions

• You’ll get faster results from global collaboration

• You will surpass submission requirements

Jumpstart CRF Management and Exceed Electronic CRF Submission Requirements

Scanning CRFs into CRFTrack saves time and is easy to use. You’ll benefit from the direct electronic conversion, with greater flexibility to organize and track your CRFs and perform QA and QC processes. CRFTrack consistently produces CRFs that are guidance-com­pliant and archive-ready in PDF format for all patients required in a submission. With CRFTrack, you have at your finger­tips the most powerful and flexible PDF conversion and formatting tool avail­able, guaranteeing that your CRFs meet and exceed electronic CRF submission requirements and standards.

CRFTrack Features Include: • Missing/containing pages

• Cross-patient searches

• Efficient barcode and OCR indexing

• Full document and page level history

• Adverse event review by the medical reviewer and DSMB

• Very fast PDF conversion of fully compliant CRFs with needed bookmark and navigational links

• Remote data review via Web

CRFTrack CUT TIME AND COST

   

CRFTrack 4.2.X Architecture Admin Tool

CRFTrack aT a GlanCe A fully integrated electronic trial and data management system, CRFTrack supports all trial management function and paper, fax, and electronic capture methods. CRFTrack also provides a link between paper and electronic environments that:

• Tracks CRF across the CRF lifecycles

• Links all relevant working groups as collaborative teams

• Produces submission-ready CRFs

• Scans CRFs from remote sites into a central database

• Creates and prints reports to monitor clinical trial activity

• Allows fax-in CRFs from remote investigor sites

• Uses automated workflow

• Distributes work globally

• Provides immediate, 24x7 access to CRFs and DCFs

• Prepares CRFs for electronic submission to regulatory agencies

WebStation

SmartViewer RemoteScan Agent Manager Integration Module

Oracle Microsoft

PDF Rendition Agent

Streamline Clinical Trials Workflow

The parallel processing of clinical trial data across teams allows for a true cross-disciplinary effort. CRFTrack routes pages securely across the entire organization, assigning and/or restrict­ing access to CRFs and functions as necessary. CRFs can also be archived in CRFTrack, or easily uploaded to an EDMS. They can also be converted on-the-fly during uploading, allowing EDMS users to access CRF pages anywhere, anytime through the EDMS interface. CRFTrack also provides split-screen data entry integration with programs such as Oracle Clinical and ClinTrial.

Remote Access Anywhere

CRFTrack offers optional Web-based access to real-time data for both in-house and remote users, including medical advisors, project managers, clinical research associates, monitors, data entry and data management staff and regulatory operations. Reviewers can verify CRF collection, view and resolve queries, and make on-the-spot decisions.

With Microsoft .NET architecture, the CRFTrack WebStation and the newest feature, CRFTrack Smart Client Viewer, offer all the benefits of a thin client solution combined with the rich user experience of a full-featured application, such as multiple document interface and dockable windows.

WorkStation

Module

Connector

Documentum Upload

CRFTrack WebStation Features:

• View CRF information through a secure Web interface

• Create, view, and print tracking and various other reports

• View CRFs in PDF with bookmarks and hyperlinks

• Quickly and easily see missing patient pages and visits

• Facilitate a virtual collaborative environment for CRF review within the clinical trial team

− Equal to that of an EDC solution

• Early intervention mechanism for resolving queries

© 2014 Computer Sciences Corporation. All rights reserved. Produced 06/2014. 8202-30