All posts by Jillian Lewis

Let’s Fuel Our Body: August Wellness Month

The last three weeks, we celebrated August Wellness Month with a look into exercise, mindfulness meditation and social connection. As a company who values the health, wellness and happiness of our people above all, this week we’re going to talk about another element we can use to fuel our wellness journey: the food we eat.  

Two years ago, the American Cancer Society reported a strong correlation between obesity and cancer. Obesity is rapidly surpassing smoking as the number one prevention for cancer in the United States. We often hear we should be eating paleo, low carb, low sugar, vegetarian, vegan; the list goes on and on. It may seem difficult to narrow down the “ideal diet” to factor into our unique, individual tastes and lifestyle choices.  Today we are going to highlight data from the National Institute of Health to support one of the many options for fueling our body with nutritious food to support our wellness long term.  

Studies from the National Institute of Health found the Mediterranean diet to be one of the most efficient in terms of nutrition, weight loss and longevity. It also reduces the likelihood of diabetes and heart disease. In one study, participants on a Mediterranean diet resulted in a 25% reduction in cardiovascular disease.  

The traditional Mediterranean diet has a strong plant-based component consisting of whole foods such as fruits, nuts, vegetables, beans, and whole grains. While red meat, sugar and salt are rarely consumed, fish and poultry make up a large portion of the traditional Mediterranean-inspired diet. If we find ourselves hungry between meals, we can curb our appetite with a handful of nuts, vegetables or fruit to satisfy any cravings. Fueling our body with nutritious food does not have to uproot our lifestyle. An easy way to stay on track during your wellness journey is to record food intake.  

In today’s digital age, there are many ways to take control of monitoring what we use to fuel our body. Here are some popular apps to record our food intake:  

We hope you enjoyed our month-long wellness celebration! As we continue to get moving, mindful, build social connections and fuel our bodies, we hope you remember wellness is a lifelong journey— let’s enjoy it!  

Let’s Stay Connected: August Wellness Month

Nearly six months into the fallout of the global pandemic, many of us are facing the heightened challenges of adjusting to our new “normal.” It seems socializing, or lack thereof, with our friends, family and coworkers has taken the hardest hit on our daily routines. Here at CSG, our greatest mission is to engage our employees by feeling emotionally connected to our work, our purpose and each other. 

Studies have found having a strong sense of social connection decreases anxiety and depression, and research has pointed to a longer lifespan in individuals with strong social relationships. Since many of us are not able to connect socially in person, here are some fun tips to build connection with others, safely:  

  • Print a blank calendar or agenda. Block off hour long windows at night or on the weekend to schedule a time to call up friends and family you haven’t spoken with in a while. Give them a call and get an automatic mood-booster.  
  • Meet your neighbors (from six feet away ?). Does anyone else find themselves going on more walks than usual? Stop and say hi to the friendly faces who share your street! 
  • Host a virtual coffee hour. Every Thursday our team meets in the morning to reconnect and share some thoughts and stories to get us excited about starting our day off strong.  
  • Start a virtual book club. Select a book you and your friends or co-workers are interested in reading and meet virtually to discuss any valuable insights and takeaways. Our team recommends Grit by Angela Duckworth.  

The willingness to reboot, connect and build strong social interactions are necessary to create rich, meaningful connections and promote overall wellness. The next time an opportunity arises to have a long conversation with someone you care about, take a walk, or spend some extra time with your co-workers, remember to do so is to put your wellness first. The bonds you may cultivate are a natural remedy to promote overall wellness. 

Let’s Get Mindful: August Wellness Month

Last week we kicked off August Wellness Month with a look into the importance of incorporating engaging hobbies into our lifestyle and launched our internal “CSG Steps” challenge to raise money for No Kid Hungry.

As we continue to work our way to 10,000 steps each day, we are certain to feel overwhelmed with trying to find enough time in the day to accomplish it all—work, exercise, quality time with friends and family, etc. Today we would like to present a way to combat the stress and anxiety life may bring by taking part in mindfulness meditation.  

Studies have shown that mindfulness meditation, a mental exercise in which one focuses deeply on their surroundings and sensations, leads to a significant reduction of the inflammatory responses caused by stress. Chronic stress can lead to high blood pressure, restless sleep, and can trigger an increase in levels of anxiety and depression. The mindfulness meditation practice to reduce stress can take form in various breathing exercises, mental imagery, environmental awareness (sights, sounds, smells), and muscle and body relaxation.

The benefits of this meditation practice present a positive correlation with high levels of stress. The more stressed an individual feels, the more meditation can significantly reduce those stress levels. Dedicating a few minutes each day to practice mindfulness meditation can help lower blood pressure and anxiety, reduce the likelihood of depression, improve sleep, sharpen our attention span, and even slow age-related memory loss; all by simply taking a spare moment or two to be still, breathe, and focus on our surroundings.

Life can be chaotic. It comes as no surprise taking a few minutes to be still can have significant benefits on our overall health and wellbeing.  If you’re saying to yourself,”I don’t have a spare minute in my day,” we would like to challenge you to start small with 1-2 minutes of deep breathing and see the immediate benefit creating a sense of calmness can bring.  

If you would like additional tools to get started on your mindfulness journey, here are a few apps and resources we recommend:  

Let’s Get Moving: August Wellness Month

August is National Wellness month! During these 31 days individuals are encouraged to focus on self-care, build healthy habits, and tune in to one’s overall physical and mental health. As a company centered around the wellbeing of others, who treasure our team members supporting life-saving clinical work, last month we challenged our team to share creative ways they are creating healthy habits and staying active. Each week during August Wellness Month we will share tips on forming healthy habits with exercise, meditation and mindfulness, healthy eating and social connection. 

The Center for Disease Control (CDC) has determined four unhealthy habits which lead to decreased health:  

  1. Tobacco use 
  1. Inactivity 
  1. Poor nutrition 
  1. Substance abuse 

With inactivity ranked number two on the list, it is imperative for individuals to keep active with hobbies and exercise. It often feels difficult to translate what we know, such as walk 10,000 steps a day and eat fruits and vegetables, into daily actions, so we created the “CSG Step Challenge,” where we challenge our team members to get at least 10,000 steps each day. There are countless benefits to walking 10,000 steps each day. Some benefits include decreased risk of heart disease and reduced stress levels.  

Leading a healthy life does not only mean getting enough steps each day. It also means incorporating healthy hobbies into our lifestyle. We asked members of our team to share hobbies they use to stay busy and active. From building a chicken coop to building a screened in porch, from remodeling a car to spending some extra time in nature, our team has found crafty ways to create healthy habits by embarking on hobbies which energize them.

In summary, having healthy hobbies, an active lifestyle and moving body is always moving in the right direction—toward overall wellness. Join us further in celebrating Wellness Month as we get moving in support of No Kid Hungry, a nonprofit working to ensure every child in the United States has access to healthy food where they live, where they learn, and where they play. Stay updated on CSG’s Step Challenge and follow our fundraiser’s progress here. We are looking forward to kicking off August Wellness Month with an overarching goal of caring for our most precious asset: ourselves.  

Traceability Webinar Series

Click here for the recording of Part 1: Building Traceability into ADaM.  

Click here for the recording of Part 2: Record Level Traceability. 

Click here for the recording of Part 3: Metadata Traceability

Part 3: Metadata Traceability  

This Friday, July 17th at 12 pm ET, Clinical Solutions Group is teaming up with Nurocor to host the last of our traceability webinar series. During this advanced level webinar, we are going to take the concepts of traceability and introduce how to use them with technology to support a platform for creating and automating the delivery of regulatory materials. We will delve into defining and understanding metadata and introduce metadata driven technology. Through how specifications can be used for submissions, as well as, tracking, automating and measuring traceability. Click here to register for Part 3: Metadata Traceability this Friday July 17th at 12 pm ET.  

Upcoming Webinar Panelists 

Paul Slagle, Senior Director, Data Standards & Process, Clinical Solutions Group 

Eric Larson, Senior Standards Engineer, Data Standards & Process, Clinical Solutions Group 

Barrie Nelson, Chief Standards Officer, Nurocor 

Traceability Webinar Series Part 1 & 2:  

We kicked off our traceability webinar series on May 15th with the basics of traceability as Paul Slagle and the Data Standards & Process team discussed the importance of traceability, how to ensure traceability, and how to check traceability before submission. During Part 2 of our webinar series, on June 19th, the panelists came together to share how to take traceability to the data. During this intermediate/advanced level webinar, the team dove into building traceability into the study design and introduced methods to measure traceability so that a team can monitor progress throughout the study.  

We are immensely grateful for the audience who remained engaged and asked insightful questions throughout both Webinar 1 and Webinar 2. Please let us know if you have any questions or feedback. 

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.

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.