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Mental Health Awareness Month

RALEIGH, NC – As we honor May as Mental Health Awareness Month in the midst of a global pandemic, it is now more important than ever to use this time to share the importance of mental health treatment, support and service, and do so by providing our own experiences to help one another. Today we celebrate our Senior Director of Biometrics & Submissions, Jen Nash, who has dedicated her time, effort, and life’s work into advocating for mental health awareness and research.

Most recently, Jen has contributed to research efforts in the areas of Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD). Recent studies have shown that mental health disorders have a larger economic cost burden than any other somatic disease.  As a complex disease, significant research is still needed to understand and treat these disorders. Jen Nash recently earned her master’s degree in bioinformatics, and completed her master’s thesis work centered on the mapping of Electronic Health Record (EHR) data to the MDD and PTSD non-standard Study Data Tabulation Model (SDTM) variables outlined in their respective Therapeutic Area User Guides (TAUGs).  Several studies have looked at the availability of Electronic Health Record (EHR) data through the Fast Healthcare Interoperability Resources (FHIR) standard; however, only standard variable data from the SDTM and Analysis Data Model (ADaM) were considered in these studies. The SDTM standards focus on safety and other data in common across all therapeutic areas. In making decisions to adopt FHIR for a single study or more broadly, the percent of study data routinely available through FHIR resources is a key factor. Because efficacy data is less commonly represented in SDTM domains, therapeutic area data element work is necessary. To assess the availability of efficacy data for Phase III mental health studies, Jen and her team mapped FHIR Resources at a maturity level 3 and above to the FDA Therapeutic Area (TA) non-standard data elements listed in the Clinical Data Interchange Standards Consortium (CDISC) TAUGs for MDD and PTSD. An average of 63% of the TAUGs’ data elements for the assessed mental health therapeutic areas mapped to maturity level three or above. Additionally, 90% of the data elements for the respective therapeutic areas mapped when considering all resources regardless of maturity level.  Preliminary mappings were vetted and presented to the FDA showing an example of end to end mappings.  This work has also been shared with larger initiatives attempting to map SDTM variables across all therapeutic areas from FHIR R4 resources.

We would like to thank Jen for her continued contribution to the Mental Health Research field. We honor all the individuals who dedicate their time to creating a world where good mental health is the foundation of a good life.  For more information on how to get involved in Mental Health Awareness Month, visit https://www.nami.org/Get-Involved/Awareness-Events/Mental-Health-Month.

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.