CDISC Services
Life sciences companies are rapidly adopting the CDISC standards, both to conform with regulatory direction and to realize the intrinsic benefits of standardization. Drug, device and vaccine manufacturers need to adopt a strategic approach to CDISC implementation at the enterprise level to fully realize the benefits, such as:
- Submitting electronic clinical trial data to the FDA in the specified CDISC SDTM format, and potentially accelerating the regulatory review process
- Improving communication and collaboration with FDA reviewers
- Easing the integration of data from multiple trials, to support pooled analysis
- Expanding pharmacovigilance programs to better capitalize on data collected in clinical trials, such as by improving safety signal detection
Phase Forward and Lincoln Technologies have played an active role in CDISC standards development activity since its very beginning, and we have made a major commitment to providing support for CDISC standards throughout our product line. Our CDISC product and service offerings have been deployed at major organizations and regulatory agencies around the world. We provide a full range of consulting services to assist your company in understanding the business benefits of using the CDISC Study Data Tabulation Model (SDTM) and other CDISC standards such as ODM and LAB, and getting started on strategic initiatives within your own company:
- CDISC Strategy Development. Our experienced consulting team will help you plan, implement and measure the impact of an effective CDISC strategy for your organization. Our consultants also can help companies to apply SDTM concepts when setting up clinical databases, so as to reduce the need for data conversions later on.
- CDISC Data Conversion. Converting existing legacy data to CDISC SDTM format will not only make data submission-ready, but also will allow sponsors to realize the value of using tools such as our WebSDM and Empirica Study products to review clinical data to support the development process and populate cross-study data warehouses. Data conversion services can be used to convert legacy clinical data as part of regulatory submissions, to allow use of review tools for immediate benefits, or as a transitional approach to an enterprise implementation of CDISC. Data conversions are available for clinical trial data in most electronic formats, including commercial and homegrown EDC and CDM systems.
- CDISC Training. We offer standard and customized training on the use and application of CDISC SDTM, LAB (Laboratory Standards) and ODM (Operational Data Model) standards in conjunction with our products and services.
