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Cases for Smarter Research

These cases studies reflect experiences using CDISC standards to improve the quality, efficiency and cost effectiveness of clinical research processes from protocol through analysis and reporting.

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. 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.

Developing and Implementing LAB: A Case Study from Covance

One of the largest components of clinical trial data is laboratory data. Developing a standard lab data format is critical to achieving CDISCís mission of creating standard data models that support the end-to-end data flow of clinical trials, from the data sources into an operational database and through to analysis and submission. Read the case study