All posts by Jillian Lewis

Nurocor and CSG Partner to Create a New Solution for CDISC Efficiencies

Nurocor and CSG combine leading metadata technology with CDISC Subject Matter Experts

RALEIGH, NC. – February 18, 2020 – Nurocor and CSG are pleased to announce at the SCOPE Summit that they have entered into a partnership that combines Nurocor’s leading clinical lifecycle technology with CSG’s CDISC Subject Matter Expertise to improve the effective use of CDISC standards in the industry.

“We are excited to partner with CSG to drive efficiencies for companies leveraging CDISC standards,” said Alex Lazar, Nurocor President and founder. “CSG’s extensive CDISC subject matter expertise helps customers use the Nurocor Clinical Platform to optimize their clinical process.”

In this partnership, the CSG Standards Group provides the subject matter expertise in the use of standards and configuring those standards to support Nurocor’s clients, and Nurocor provides the Nurocor Clinical Platform along with its expertise in metadata repositories. The leader of the use of metadata at CSG, Paul Slagle, Senior Director of Data Standards & Process, explained that “the Nurocor Clinical Platform provides the technology that allows our teams to document the traceability of standards in a clinical trial from collection through analysis.” Combining the Nurocor Clinical Platform with the expertise of both companies, they help organizations implement and seize the benefits in the use of their clinical trial metadata throughout their operation, thereby reducing the time to analysis while maintaining the quality and consistency of the clinical trial data.

“The partnership of Nurocor and CSG allows us to provide increased support to our clients in submission support,” said Omar Omar, Managing Partner of CSG Inc.

About CSG

CSG’s Data Standards & Process group provides best-in-class consulting in the use of CDISC standards, including CDASH, SDTM, ADaM, and ARM. Our CDISC Subject Matter Experts are members of the CDISC Standards Team and provide a combined industry knowledge of more than 100 years in clinical trial analytics and submissions. Since our inception in 1999, CSG has developed a reputation as one of the leading niche service providers supporting our clients with service offerings in Clinical Data Analytics spanning from Functional Services, Standards Management, Staffing and Consulting. At CSG, we are focused on delivering services through the industry’s leading talent.

About Nurocor

Nurocor helps companies like Amgen, Syneos Health, Novartis, Pfizer, and Roche bring order to clinical data to improve the quality of medical research and bring new medicines to patients more quickly. Created by a team combining deep industry expertise with a proven ability to bring technology solutions to market, Nurocor MDR is the industry-leading standards metadata repository enabling the seamless interchange of data between Electronic Data Capture and Clinical Data Management systems and regulatory agencies.

Paul Slagle Launches New CSG Data Standards Division

Raleigh, NC- Clinical Solutions Group (CSG) is excited to announce the addition of Paul Slagle as Senior Director of Data Standards and Processes. Paul will lead our team of CDISC Subject Matter Experts assisting clients in developing customized solutions ranging from confirming submission compliance to end-to-end processes and tool development. Having developed biometrics and CDISC standards teams at other global biopharmaceutical organizations, he is well positioned to continue to build and expand upon CSG’s Biometric service offerings.

At CSG, we recognize that the use of CDISC standards, while a requirement by the FDA since 2017, can still be a challenge and create delays in the submission process. The Data Standards and Process team brings the knowledge and experience in delivering compliant solutions through both a review and validation process up through the development of processes and tools to streamline the work required. This minimizes rework and allows teams to focus on the quality of the data rather than how the data will be submitted. This also allows teams to apply advanced analytics earlier in the process to better understand the outcome of their drug trials. The Data Standards and Process team will help bridge the gap with sponsors trying to navigate their CDISC roadmap by bringing top talent and years of strategy and implementation experience into one group.

Paul joins CSG’s leadership team bringing over 35 years of experience.  He has been involved with CDISC standards’ development since the early 2000’s. His background includes contributing to the ADaM version 1.1 standard, the CDISC Breast Cancer Therapeutic Users Guide, and he is currently the co-lead of the ADaM Oncology Standards Team. In 2018 Paul served as the Academic Chair at the Pharmaceutical SAS Users Group (PharmaSUG) conference in Seattle. In this capacity, he helped to introduce sections for R and Machine Learning, and technology strategy into the curriculum.

CSG’s new division is a nice compliment to the existing niche Biometrics Solutions Group which provides top talent and submissions expertise to clients.  Our new Standards and Process Division is a thoughtful addition to the group allowing additional best in class service options for our clients.