CHANGE MANAGEMENT

When selecting an IRT provider, be sure to ask how quickly data changes and system modifications can be accomplished, both at study start and as the trial proceeds. Veracity Logic’s approach reduces costs, empowers users, maintains quality standards, and shortens both the time and the paperwork involved with managing change. Our robust Issue Tracking System captures all user concerns and requests for change throughout the study…and provides an easy way to ensure all requirements are addressed in a timely manner.

RELATED POSTS
  • Case StudiesJul 10

    The Classic Conundrum: “How long will it take to make a system change?”

    A never-ending tension in clinical trials exists between a client’s need for quick changes to a technical system – for example, an IRT (IWR/IVR) system in production -- and the vendor’s need for time.  The axiomatic truth is this: the details of clinical trials are often fluid, with the need +

  • Checklists can save you — stress!

    Everyone makes mistakes – it’s part of being human. We’re not automatons who simply complete tasks day in and day out. If only life were that simple. It seems there are always small “tweaks” to any process involving information management and processing. The question is, how do we minimize errors +

  • The Art of Making Changes Part 2: Focus on Process

    Change is a constant in the world of clinical study planning. In The Art of Making Changes Part 1: Five Keys we talked about the stress change can generate, and about the five essential elements for achieving painless change management for IRT (IWR/IVR) systems. The present article outlines the +

  • The Art of Making Changes Part 1: Five Keys

    Doctors will tell you that change – any sort of change – is hard on humans. As endocrinologist Hans Selye observed, “Stress, in addition to being itself, is also the cause of itself and the result of itself.” Good changes and bad changes alike elicit stress points on psychological scales. +

  • Save IRT Time and Money with an ASCA

    It’s not always big things that make a difference in the efficiency of a clinical trial --- sometimes it’s the smallest things. The IRT (IWR/IVR) database is no exception to the rule. The incorrect formatting of a fax or phone number, or an extra space in an email address where +

  • It’s 5PM, Do You Know Where Your Documents Are?

    One of the much-lamented aspects of a regulated industry like pharmaceuticals is the amount of documentation required for the successful conduct of a clinical trial for new drug development. The old industry adage ‘if it isn’t documented, it didn’t happen’ was with us at the birth of modern FDA trials +

  • Selecting a Fast, Adaptable IRT is one Key to Success

    Can Your IRT System React to Surprise Protocol Changes? If you’re on a dark ocean and spot an iceberg ahead, do you really want to be on board the Titanic? Clinical trials have hidden challenges that surprise sponsors and vendors alike. So using a vendor that reacts quickly is critical +

  • Case StudiesJun 27

    Five IRT Assists for Clinical Project Managers

    Challenge: You're a Clinical Project Manager (CPM) given a study halfway through enrollment and you need to get up to speed on study status FAST! How can your IRT help? Solution: Fortunately, you're using Veracity Logic's Interactive Response Technology system, VLIRT®. Here are five key features geared toward CPMs who find +

  • User Power: Managing Cohorts

    The Problem: The management of multiple cohorts is a standard offering of most IRTs. In the common sequential model, when Cohort 1 reaches a pre-designated limit the cohort is closed by the system and subjects can no longer be enrolled into that cohort. Problem: The design of your study is +

  • Case StudiesNov 15

    Handling Data Corrections…

    Problem: There are many options for processing manual data changes in an IRT system. Some vendors make all data changes for the clinical site users. Others have electronic systems where users can request and approve changes, while still others require 'wet' signatures. What's the best option for achieving the two key +

  • Case StudiesSep 22

    We’re midway through the study and the protocol has changed…but only for some sites. Arghh…!

    Problem: The IRT was originally configured to accept eligible subjects with a maximum age of 75. Midway through the trial, the maximum age was increased to 80...but only for sites whose IRBs had approved the increased age! What to do? Solution: Veracity Logic configures a flag on the IRT Site +

  • Can Your IRT System React to Surprise Protocol Changes?

    If you’re on a dark ocean and spot an iceberg ahead, do you really want to be on board the Titanic? Clinical trials have hidden challenges that surprise sponsors and vendors alike. So using a vendor that reacts quickly is critical to saving time and costs for sponsors. Large companies are +