Success Stories

 

In
an attempt to increase value for its stakeholders, CDISC initiated the
feature of Success Stories in 2012, and we are continuing these in 2014.
These stories reflect experiences with the CDISC standards and how they
bring success and add efficiency to the work environment. If you would
like to present your success story with CDISC in a future Newsletter,
please contact Diana Harakeh. 

 

 

A Cytel Case Study: The Use of CDISC Standards in Unilever’s Cosmetics and Food Products Trials

 

Cytel is a technology services provider that
develops statistical software, clinical trial programming and analytic
services. The company has extensive experience in clinical development
and expertise in biostatistics, operations research, SAS programming,
medical writing, data management and software development, and is a
leader in the design and implementation of adaptive clinical trials.

 

With experience migrating over 150 studies as part of
20 U.S. Food and Drug Administration (FDA) submissions, Cytel’s CDISC
Implementation Team efficiently develops CDISC SDTM and ADaM data sets
that are compliant with required guidelines. The CDISC Implementation
Team is comprised of expert programmers and statisticians that
understand the analytical requirements of complex trials and have
extensive experience preparing data for submissions to regulatory
authorities. All studies in which Cytel has led migration and submission
to the FDA have been accepted. Click here to view the full article.

 

Formedix: Clinical Trial Efficiency Using CDISC Standards

 

Formedix develops clinical trial automation software
and services to promote efficiency for CROs, Pharmaceutical and Biotech
companies, and EDC vendors. Formedix has been involved in using CDISC
standards for over 10 years, and their Technical Standards Director (who
has won 2 awards with CDISC) is currently working heavily on CDISC’s
Define.xml. CDISC standards have been integral in ensuring that
Formedix’s clients see large-scale reuse, and substantial reductions in
resources, set-up and EDC build time. In this article, Formedix proves
that you can automate clinical trials anywhere using the CDISC
standards.

 

Saving Time and Money

Using CDISC standards is all about making the clinical trial
process more efficient, saving time and money. Through the content
libraries that Formedix has established for many of its clients, from
small biotechs to large multinational firms, they have found that there
is significant content reuse, as much as 70-80% reuse in some cases,
with 20% less maintenance cost. These content libraries span the entire
clinical trial process end-to-end, and have been found to have a quick
ROI, in one case in as little as eight months. Follow the link for the full story.

 

 

Great Moments at the CDISC Asia-Pacific Interchange

 

Great
Moments at the CDISC Asia-Pacific Interchange The Inaugural CDISC
Asia-Pacific Interchange (CAPI), held in Singapore 18-22 February, was
an incredibly successful event, drawing over 100 leaders from Thailand,
India, Japan, Singapore, South Korea, China, and Australia, as well as
the USA, France, the UK and Belgium. While conference content included
traditional subjects, such as presentations on case studies using and
implementing the CDISC standards, there were also heavily attended and
engaging subjects specialized for the Asia-Pacific region. Specifically,
there were updates on the status of clinical research and usage of
CDISC standards around the Asia-Pacific region, region-specific
presentations on the use of EHRs for research and a highly interesting
session on therapeutic area standards, which included a presentation on
the development of standards for traditional Chinese medicine (TCM).

 

There
were many encouraging moments at CAPI, but one of the greatest
highlights, to me, was the number of CDISC Board members that not only
attended the bi-annual face-to-face Board of Directors meeting (held in
Asia for the first time), but spent the rest of the week thoroughly
engaged in the Interchange presentations and associated discussions.
Eight CDISC Board members even took time out of their very hectic
schedules to participate in a panel discussion and Q&A session for
Interchange attendees. Click here.

 

 

A
d-Wise Case Study: Validating Clinical Trial Data using the d-Wise
Reveal Platform and OpenCDISC Validator for CDISC Compliance

 

A d-Wise Case Study: Validating Clinical Trial Data using the d-Wise Reveal Platform
and OpenCDISC Validator for CDISC Compliance In June of 2013, d-Wise
Technologies, Inc. (d-Wise), a solutions provider that offers product
and consulting solutions for clinical trial optimization, metadata
management and clinical data standards implementation, released the
latest version of their web-based search platform, Reveal 2.
d-Wise has found that Reveal, when combined with OpenCDISC Validator, a
free utility for ensuring clinical data compliance with CDISC
standards, can expedite the validation of clinical data in a compliant
way.

 

When paired with OpenCDISC Validator, Reveal can
facilitate validation for CDISC SDTM, ADaM and Define.xml clinical data
standards compliance. As organizations get closer to submitting new drug
applications and amendments for eventual marketing approval from
regulatory authorities, the ability to find and aggregate data and
validate data to CDISC standards becomes increasingly important. With
Reveal, organizations can accelerate their review and perform ad-hoc
validation of their clinical trial data. Read More.

 

 

Sharing Clinical Research Data - Prepublication Release: IOM Workshop, October 2012

 

Dr. Rebecca Kush, President and CEO of CDISC stated: "The Institute of Medicine (IOM) held a workshop in
October 2012 that was one of the best meetings I have ever attended. I
participated in a great session that was chaired by Dr. Frank Rockhold
(GSK, CDISC Board Past-Chair) and Dr. Lynn Hudson (Critical Path
Institute). Dr. Hans Joerg Eichler was there to announce the EU Data
Transparency Initiative (which we will hear more about at our European
Interchange next week – see p. 58) and there were many other
enlightening presentations with robust discussion. It was an overflow
crowd and presentations were shown on video in a second room. Below is a
slide that I developed, based upon this workshop, for a subsequent
meeting at NIH; all of these topics were covered in the IOM Workshop and
I especially liked Dr. Eichler’s quote!"

 

The summary report from this workshop, Sharing Clinical Research Data, was released by the IOM on 29 March 2013. Follow the link to view the prepublication version.

 

 

More Case Studies

 

We
sought out our most experienced CDISC users and asked them to describe
their experiences, the issues they hoped the standard would address,
what the implementation process involved, and how the standard met their
needs. We also asked for an honest evaluation of the standard and
requested their suggestions for improvement of the standard they used.

What
follows are the stories of our users’ real-world experiences with the
CDISC standards. We hope you find these stories encouraging and helpful.