Wingspan

Is your TMF Complete? Folderless Navigation

Meghan McKeown — Fri, 20 Jan 2012 23:35:16 +0000

One of the most difficult things about the TMF is navigating the collection of documents at any given time to measure its completeness. How does a study owner know what is missing or what is coming due?

Historically, TMFs were organized with a folder hierarchy structure. Study owners could not tell what was missing without spending hours cross-referencing the documents to a stack of spreadsheets. Finding specific documents took too much time clicking through folders and the spreadsheets were often incomplete.

The creators of DocWay TMF recognized this problem and remedied it by building the system with folderless navigation (the same technology used in DocWay UI). Now, study owners can find specific documents in just one or two clicks, saving time and aggravation.

The Importance of a Complete, Consistent, and Compliant Trial Master File

Meghan McKeown — Fri, 20 Jan 2012 23:34:39 +0000

Pharmaceutical companies have continually faced a growing challenge when it comes to clinical trials. Regulatory authorities have cited these companies as missing required documents in their Trial Master Files and accused them of putting patients and consumers at risk. Failed inspections have led to more frequent visits, large financial penalties, and even revocation of the clinical trial itself. Pharmaceutical companies must find a solution to this problem: a solution that makes their TMF complete, consistent, and compliant.

DIA members have recently recognized this need, formed a SIAC, and set out to create the TMF Reference Model, a manifest of the most common and widely used documents in a Trial Master File. Introduced in February 2011, the Reference Model aims to “provide a single, unified interpretation of the regulations via a document listing which is accepted across the industry.” (Rammell, Eldin, “Rationale for the Model.” Retrieved September 9, 2011 from tmfrefmodel.blogspot.com). While the TMF Reference Model provides organizations with a solid starting point, actual TMF document lists must be modified to fit the individual company’s needs to insure completeness.

Wingspan Technology recently developed a software solution to address the needs of the TMF; moreover, its unique features offer a completely new approach to the Trial Master File. Stay tuned to this blog for more details and information on how Wingspan’s eTMF can make your Trial Master File complete, consistent, and compliant.

Welcome to Wingspan Technology’s Blog

Meghan McKeown — Mon, 02 Jan 2012 01:24:40 +0000

Hello and welcome to Wingspan’s new blog. We’re taking 2012 by storm with a new website and a new product launch in Q1. This is an exciting time for Wingspan Technology, and we cannot wait to share our developments with you.

We’ll be using this space in a variety of ways: to share our thoughts on industry trends, to explain a bit about our products, and to give you an inside look about what’s going on in our offices. Be sure to check the blog for a first look at the details of Wingspan eTMF, for information and opinions about the pharmaceutical and life sciences industry, and for the transition into the cloud.

Holiday Giving at Wingspan Technology

Meghan McKeown — Mon, 12 Dec 2011 01:21:48 +0000

Happy Holidays! For the past five years, Wingspan Technology has participated in The Center Foundation’s Holiday from the Heart program. Wingspan adopts a number of families who cannot afford to provide their families with gifts and festivities during the holidays, and collects and donates gifts.

In 2011, Wingspan adopted three young families. Our staff members and their families gathered gifts including clothing, gift cards, baby and toddler toys, a pack-and-play, and other essentials to give at Christmas.

For more information about The Center Foundation, visit http://www.thecenterfoundation.org/