Veracity Logic-Medrio Integration Spells Success

Case Studies

Through Integration of Medrio and Veracity Logic, Atlantic Research Group Expands Capabilities

Finding themselves under a strict timeline and in need of drug supply management, Atlantic Research Group was searching for a way to bolster their software repertoire. Using a free API from Medrio, they were able to access the comprehensive drug supply management capabilities of Veracity Logic without forfeiting Medrio’s top-shelf electronic data capture.

Meet VL at OCT Southeast 2017 in Cary, NC

Events, Newsletter Archive

This locally-focused event attended by the RTP biopharmaceutical market (and more!) looks at key challenges faced by small to mid-sized biotech and pharma companies in the Southeast and facilitates learning and problem-solving through case studies and discussion among peers. We’d love to meet

Why Visual Verification?

Case Studies

The Problem: On the one hand we’ve got statistics. On the other hand, we’ve got human lives. Because of the latter, our hearts tend to have zero tolerance for errors in clinical trial data. How do we find the right level of risk and quality control (QC)?

Let’s tempt the wrath of risk assessors everywhere and look at the issue. What’s the real purpose of QC? To be sure, it is NOT to achieve perfection. On that most of us can wholeheartedly agree, including the FDA.

The question is how to decide how much and which types of QC will help ensure the acceptable error margins we’ve set for ourselves.

That’s a whole other kettle of fish.

The Solution: What we strive to produce is a quality management system that works as a whole. Over time, we add and subtract QC tasks until the right balance emerges—one that satisfies both the risk assessment model and the passion for correct data.

At Veracity Logic, one of the steps in our total QC package is a little bit of bother known as “visual verify”. We’ve reached down into the data management archives, pulled it out, dusted it off, and propped it up on the mantel, remembering a time when it was axiomatic that any single-entry act in the double entry world of quality control had to be independently reviewed. One can almost hear the wooden wagon wheels creaking….

Every data change (DCR) and configuration change (CCR) we’re asked to make in an active IRT project system is executed by a qualified project team member and then subjected to an independent visual confirmation by another qualified member of the team. Successful verification is signed off by the reviewer and becomes part of the project record. Only then is the DCR/CCR regarded as complete.

One almost wants to hum the theme song from ‘Somewhere In Time’…

Getting to Market Faster…

IRT Essentials

Getting to market faster is one of the major goals of every pharmaceutical company. Going paperless is one way CROs are reducing the time–and costs–required to complete and close a clinical trial.

According to CenterWatch (June 27, 2016), Sponsor use of electronic Trial Master File (eTMF) applications has doubled in the past two years. At the same time, use of paper for Trial Master Files has dropped to 28%.

As more CROs adapt to being paperless and bring their eTMF applications online, they need vendors who are able to keep up the same pace. Aware of the goal, Veracity Logic uses an electronic repository to store all of its project documentation. Once documents are fully executed (all relevant parties have signed off), they are moved to a shared electronic portal where the client is given access to download on demand any and all documents required for the Trial Master File.

“We understand the goals of the industry and are supporting those goals by having project documentation available to our clients long before database lock,” says Andrea DeStefano, Project Manager at Veracity Logic.

User Power: Managing Cohorts

Case Studies

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 such that the maximum number of subjects in each of your four planned cohorts cannot be fixed at study startup, and more than one cohort can, in certain circumstances, be open simultaneously. How should the IRT be set up to provide this kind of adaptability?

The Veracity Logic Solution:

A typical approach to achieving flexible cohort functionality is to assign the task to the system development team. Programmers and configuration managers would modify code or system configurations during the trial as needed to adjust cohort parameters. Additional costs, time delays, and the need to produce change orders and approval documents for interparty communication, are three notable downsides to this approach.

Veracity Logic’s IRT platform supports an alternate strategy. In addition to system controls, we offer a user-friendly, manual approach that puts the power of change directly into the hands of authorized users. Cohort parameters are configurable, no coding changes required. Cohort limits can easily be modified and re-modified with the click of a button. Likewise, cohorts can be manually opened and closed, re-opened and re-closed on demand, all by the users themselves, and in the users’ own timeframes.