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 firstname.lastname@example.org
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 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.
- Eli Lilly Example ODM Library
- Further details about the Eli Lilly Case Study
- Case Study: Using ADaM Data in an FDA Submissions by Lundbeck
- Case Study: Wyeth's Team Approach to CDISC Implementation
- Case Study: Using SDTM to Map Multiple Studies: A Case Study from Symbiance
- Case Study: Process Reengineering: Implementing SDTM: A Case Study from PharmaStat
- Case Study: Developing and Implementing LAB: A Case Study from Covance