InForm Integrated Trial Management (ITM)

Phase Forward

Overview

The Phase Forward InForm Integrated Trial Management (ITM) platform delivers the most robust Electronic Data Capture (EDC) solution in the market. Yet its flexible and scalable architecture and user-friendly design accommodate the needs of smaller organizations looking for solutions today that will expand to meet their needs tomorrow.

The InForm ITM platform provides comprehensive data entry, edit-checking, and query management functionality for data capture and data cleaning. The robust reporting and analysis capabilities provide real-time access to trial data. With timely and insightful views into trial data, sponsors can make more informed decisions, mitigating risks and improving overall trial conduct.

The InForm ITM supporting modules encompass trial setup and design, trial conduct, standards-based document archive and submission, and integration with third-party clinical and non-clinical software solutions.

Benefits


  • Enables bio-pharmaceutical companies, medical device companies, CROs, and AROs to integrate and automate the management of their entire clinical development process.
  • Combines leading EDC capabilities with built-in reporting and analysis functionality to deliver management tools for better, more efficient trial management.
  • Real-time access to clinical data and operational trial metrics needed to make accurate and timely decisions.
  • Enables rapid retrieval of both clinical and operational data, real-time performance monitoring, trend analysis, and exception handling while reducing costs, limiting on-site administrative visits, streamlining production time, and shortening decision cycles.
  • Early and real-time access to data saves time, money, and development resources while also mitigating the safety risks associated with clinical development.
  • Web-based, zero-footprint solution.
  • Reporting and analysis tools are out-of-the box. A pre-defined and purpose-built reporting model based on Phase Forward best practices is included and ready-to-deploy. The reporting schema is open and publishable, facilitating ease of interoperability with other data management and reporting systems.

Features


The InForm ITM platform and its supporting modules provide clinical sites and trial sponsors with all the tools required to efficiently conduct and manage EDC-based clinical trials:

  • InForm Architect is an easy-to-use drag and drop design tool for fast set up and design of trial forms, visits, and defined edit checks.
  • InForm Portal provides a communication vehicle for site and sponsor information exchange and document management with version control capabilities.
  • Central Coding for InForm facilitates multi-study, industry-standard, and customized coding of drug names, indications, and adverse events.
  • InForm CRF Submit generates electronic common technical document (eCTD) compliant Adobe PDF editions of the InForm ITM electronic case report forms (eCRFs) for site and sponsor archive and eSubmission to regulatory agencies.
  • InForm Adapter provides a number of Web services-based interfaces that enable integration, extensibility, and workflow across the InForm modules and with other third-party software systems.
  • InForm Reporting and Analysis leverages a built-in reporting model that enables a sponsor's staff to run both standard and ad hoc operational and clinical reports.

Architecture

InForm ITM ships with 32 dynamic and configurable standard reports along with an advanced ad hoc reporting environment. It delivers unprecedented functionality into the hands of study managers, lead Clinical Research Associates, and Clinical Data Managers. Reports include:

  • CRF Status Summary by Site
  • CRF Site Performance Summary by Site
  • CRF Cycle Time Detail by User
  • CRF Aging by Site
  • Query Status by Site and Subject
  • Query Performance Summary (by site and user)
  • Query Volume by Month by Site
  • Query Cycle Times by Site
  • Subject Enrollment Status (by site and user)
  • Subject Dropout Counts by Reason
  • CRB Completion and Query Summary (by site and user)
  • SDV Item Listing
InForm ITM adheres to regulatory guidelines for drug and device development including Good Clinical Practices (GCP) and FDA - 21 CFR part 11. It also supports the Clinical Data Interchange Standards Consortium (CDISC) standards for data and submission.

Availability

For more details, visit our Website: www.phaseforward.com.
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