The Single Interface™

• A single integrated study portal that contains all study data including site information, TMF, EDC, CTMS, CDMS, labs and diagnostics, safety and budget and financial data
• Provides role-based views tailored to the function of each type of user
• Custom reporting tools that allow flexible views of any and all data that may be easily downloaded in spreadsheet or pdf form
• One place with one login for everything related to your study

Core Integrations - data consolidation and reconcilation, of external sources

• Integrates multiple siloed systems and data sources, automatically reconciles clinical, diagnostic, safety, supplies, trial management, financial and monitoring data
• Provides improved results in enrollment for local populations, globally
• Tightly manages coordination and accountability of both large and small suppliers and groups
• Harnesses, consolidates, reconciles and reports across geographic pillars
• Live, study conduct transparency, with 24x7 access, in appropriate, blinded, role-based views
• Efficient, rapid turn-around of information results - key performance indicator of data lock within hours of LPV

ProAction™ IxR

• Centrally manages a global inventory of clinical supplies from API through to patient, accurately and on time
• Flexible to manage patient allocation, site inventories, depot inventories at kit or component level
• Expiry and stability management at kit and component level regardless of physical location
• Provides the highest degree of control throughout the trial process giving sponsors complete oversight transparency via The Single Interface™
• Fully integrated with lab, and other diagnostics to accurately automate stratification, randomization, and cohort management
• Automated reconciliation with CRF data
• Acclaimed as the easiest-to-use interface – set up complex trials in days, not weeks or months with validated configurable platforms
• For global trials used by study teams despite language barriers or time zones

Site Launch Logistics System

• Extremely intuitive user interface fully dedicated to the needs of life sciences companies
• Display of live or time delayed clinical study metrics via live connection to popular clinical data management systems
• Full featured customizable web page presentation tool with the ability to highlight your assets with graphics, video and more
• Easy to use document framework that maps all key documents applicable for regulatory submission to an eCTD format
• No downloads required, no installation of any software, no ActiveX™ or Java™
• Project management access available though smart phones and tablets such as iPhone and iPad

TruPoints® Partnering Management

• Facilitates a rapid partnering process by combining the functions of a full featured virtual data room PLUS live feeds of study directly from the clinical systems AND stored in a submission ready structure applicable to an electronic submission
• Pulls key data from trial progress and integrates it with financial information on the company, real-time market intelligence, and the previous body of work
• Investors and potential partners can visit TruPoints and find the information they need to assess the business information, scientific, CMC and current studies and banking can create/monitor the auction process
• Interface enables authorized, interested parties to view, monitor and evaluate the trial’s progress, live

Financial Oversight

• Automatically maintains accrual of study costs driven by actual study data and work performed by sites, monitors, labs and other suppliers
• Plans and tracks master study budget while automatically calculating and generating SOX compliant summary reports
• Generates automated site and vendor payment reports for an efficient and evidence-based invoice-free financial management
• Project accounting systems and tools cross reference contract terms and prevent money paid erroneously in billing errors
• Proven process for efficient and effective money management ensuring bills are paid for deliverables completed on time, with the necessary level of quality and according to contractual obligations and budget
• Tracks site charges and assigns to appropriate payee such as sponsor, insurance or grants

ProAction™ Suite Clinical Data Management and Clinical Trial Management

• Provides rapid start up and set of entire clinical database including CRFs, data sets, validation and edit checks
• Alert messages available for all clinical events
• Fully integrated with all diagnostics, safety and IxR data
• Facilitates rapid data lock and provides data on tap in multiple formats including SAS, Excel and others
• Works with CDISC standards for CDASH, ODM and SDTM. Can be configured to support any custom formats

ProAction™ Site Tools (Site Works)

• Easy to use site-based study interface that works on the web, tablet PC, iPad, IPhone and other mobile devices
• Allows sites to record data in a flexible automated workflow to comply with the protocol and allow the flexibility to work with the site’s practice
• Works in the exam room and can serve as electronic source
• Provides site staff with all diagnostic results available for each patient, trended over time
• Simple query resolution tools that save time and effort

ProAction™ Monitoring Management

• Builds automated monitoring plan and schedule and assign monitors based on site activity
• Facilitates remote monitoring and significant reductions in travel cost
• Manages which data requires source review and focuses monitor attention to critical issues
• Provides automated key task lists to monitors
• Generates automated trip reports and telephone contact logs
• Tracks monitoring status per monitor, by region and overall study

Patient Safety — Safety Management

• Fully integrated and reconciled with clinical database
• Tracks reporting process and generates all data for MedWatch and CIOMS forms
• Manages reporting workflow with alert system
• Generates and sends Dear Dr. letters
• Prepares summarized data for report safety reporting

SiteBook™ Investigator Portal

• Provides the sponsor with a direct relationship with the community of investigators for a moderated medical and scientific dialog with the added value of being convenient for site resources
• The community for engaging the physicians and facilitating a two way exchange of information
• Significantly improved physician education, involvement and interest/engagement
• Supports automated site feasibility, CDA management, contract and budget management, and electronic Trial Master File (eTMF)
• Manages workflow of entire site start-up process

Reimbursement Analysis

• Collects, summarizes and reports appropriate pharmacoeconmic information from first in man through approval
• Provides solid evidence for reimbursement for both payees and partners
• Enables investors and sponsors to determine the pricing of the finished product
• Allows for accurate projection of market value of drug

Submissions Management - eCTD

• Preparation of electronic submissions for NDAs in eCTD format
• Document management, searching, TOC management, linking and publishing
• eCTD viewing and validation
• Available for NDA and IND