Since CDISC’s inception, two of the organization’s core principles have been to “lead the development of standards that improve efficiency while supporting the scientific nature of clinical research” and to “maintain a global, multidisciplinary, cross-functional composition for CDISC and its working groups” (CDISC Mission & Principles). We highlight these two principles as we strongly believe neither can be achieved in isolation from the other.
At Veristat, a full service CRO, we pride ourselves on having modeled our CDISC Implementation Services team and approach in keeping with these ideals. This team is comprised of in-house Statistical Programmers, Biostatisticians, Clinical Data Managers, Data Standards Managers, Database Developers, Medical Writers, and medical experts who have experience in all phases of drug, biologic, and device development cycles. Their collective approach is to utilize CDISC standards as a common language in order to effectively share their experiences and draw upon each other’s expertise. This diverse collaboration and common logic transforms those concepts and practices into high quality and cost-efficient study deliverables, clear submissions that conform to regulatory standards, and an ever-increasing number of experts within Veristat and the companies we work with.
Whether conducting gap analyses of clinical documents and source data on legacy trials, identifying the impact of missing or nonconforming data on analyses, developing a new domain that fits the structure of the observation classes defined in the SDTM model, or designing CRFs, operational databases, and analysis datasets that blend both a sponsor’s needs with the CDISC guidance and regulatory requirements, our CDISC Implementation Services team has seen and done it all. As early adopters of CDISC standards, and subsequently early appraisers of the inherent challenges and benefits, Veristat can confidently affirm that CDISC continues to meet and exceed its core mission statement and principles which are synonymous with our own (Veristat Mission).
