Data Standards & Process.

Partnering with clients on their CDISC journey.

 

Since our inception in 1999, CSG has been a trusted industry partner. Our commitment to our clients continues with the deployment of our Data Standards and Process Team (DS&P).  Our team is comprised of industry thought leaders who contribute to the development of the most recent standards and leverage that knowledge in working with our clients and their projects.  CSG is prepared to support your initiative at any stage of its CDISC journey, from offering expert consultation to partnering on long term initiatives including the creation of your standards and building code to deliver.  Our team’s depth and breadth of capabilities will guide you through each segment focused on outcomes that increase accuracy with reduced time to approval, traceability of results to data, all while realizing an increased cost-benefit.

 

  • Tool Development & Support

    CSG’s SMEs assist clients who have already implemented CDISC with the creation of best practices for the use of CDISC Standards. Our team’s vast exposure to various sponsor and CRO systems enables us to gain efficiencies in a client’s working environment and leverage existing processes to gain efficiencies through the sharing or development of new macros and tools.

  • Technology Implementation

    Our teams have experience in the implementation and use of technologies including, metadata, metadata repositories and Object Data Model (ODM), for the governance of CDISC within an organization. Our SMEs collaborate with our clients to develop goals and plans, implementation, and training in the use of CDISC metadata tools, including the implementation of metadata with EDC tools and other ODM compliant systems.

  • CDISC Engineering

    Creating CDISC compliant data can be challenging in today’s complex clinical trial landscape. Our DS&P Team offers a combined 100 years of experience in CDISC, assisting our clients in the design and/or creation of Trial Design Development, CDASH, SDTM, ADaM, ARM, and the submission of DEFINE.XML, Study Data Reviewers Guides (SDRG), and Analysis Data Reviewer Guides (ADRG).

  • Harmonization

    Building an ISS/ISE can be challenging, especially when legacy studies with various CDISC versions are involved. Our team can coach or harmonize data into integrated databases for use in submissions or further analysis in data warehouse/lake technologies. Clients have leveraged CSG’s DS&P team to perform Harmonization of their systems allowing them to benefit from the integration tools and macros that are used when creating an ISS/ ISE allowing for future traceability.

  • Compliance Reviews

    Third-party reviews assist our clients in compliance and error resolution. Our capabilities can confront problems ranging in scope from those that require data revisions to others that can be resolved with documentation. thereby helping clients meet compliance guidelines without extensive delays in submissions.

  • Training and Mentoring

    Clients leverage our Subject Matter Experts (SMEs) to not only develop training using their SDTM, ADaM and CRF standards but also provide additional follow on support, post-training, to assist in driving compliance and proper implementation in their clinical trials.

Our Data Standards & Process Team

Karen Curran
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Paul Slagle
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Eric Larson
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Nancy Brucken
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Karl Miller
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Deborah Nunner
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Press Release & Overview