News & Insights

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.

Technology and Remote Work: 5 Programs that Will Improve Remote Productivity

Technology has created opportunities that few people could’ve imagined just a decade ago. From social media to FaceTime, there are countless ways that people can connect instantly without having to leave their homes, making remote work more and more popular. Remote employees want fast and fluid technologies that can link them with in-office coworkers as seamlessly as possible. To increase employee engagement and performance management, consider the following list of some of the most competitive tech solutions available. 

Fuze: Video Conferencing Technology

Unifying voice, video, and messaging into one application, Fuze increases the efficiency of communication and drives workforce productivity. It can allow employees to work anywhere, anytime, on any device. This program is equally useful for small and large businesses, and it has data protection to ensure the safety of all company communications. It is even free for meetings of groups less than 25 people. However, it doesn’t send reminder emails to participants before meetings, so that will have to be done manually.  

Slack: Group Chatting Technology

As an alternative to email, companies are turning to apps like Slack to message large groups. This can be helpful when collaborating on projects and presentations. Instead of searching through email chains to find dates and information, they are all contained in one channel that participants can create. Slack also has customizable notification settings and works across desktops and mobile devices. The only catch is that the free version has limited storage. 

Glint: Employee Engagement Monitoring Technology

Designed to help employers measure employee engagement levels, Glint is a great tool to continuously survey employee satisfaction and involvement at work. Instead of annual feedback sessions, Glint collects data on an ongoing basis through regular employee and manager evaluations. With continuous data analysis, it can help larger organizations predict risks and identify opportunities for heightened engagement. Unfortunately, this program may not be as useful for smaller organizations because it works by compiling data across many employees to show trends. 

Dropbox: File Storage and Sharing Technology

With unlimited file space for just $20/month, Dropbox is another service that is hard to beat for remote workers and the business as a whole. This shared storage site makes it possible for employers and employees to access files from anywhere at any time. It also has features like file recovery and version history, password protected links, live support, and administrative roles to secure documents.  

Teamwork: Project Management Technology

Assisting teams with project management, Teamwork can help to finish projects efficiently and on-time. With countless features like to-do lists, built-in calendars, task management, commenting, activity tracking, and chatting, Teamwork is becoming widely used by businesses. Although the interface is complex, it’s one of the top workplace tools on the market. 

When technology supports workers in smart ways, they can be more productive and innovative. If you are drawn to explore technologies and solutions that allow you to collaborate effectively and connect more deeply, no matter what continent you’re working from, consider applying to one of our remote opportunities or explore our advanced services.

Boss Time Management: How to Protect Your Time as a Leader

Every leader knows what it’s like — you finally sit down at your desk to tackle some paperwork or get organized for the coming week, and almost immediately you hear a knock on your door or see a head peep inside of your office. When serving as the team leader, office manager, or anyone who supervises others, it is common to feel starved for time to finish your own tasks. Having to constantly juggle many different projects and people at once, effective leaders must put their time management skills into play in order to accomplish their goals. Below, you’ll find four simple steps that can really help you in mastering your organization and save time in your overflowing schedule.  

Get Your Inbox Organized. 

It may seem like a low-level priority but organizing your email can save you time and energy. Gaining the ability to quickly send a message to multiple contacts, search for important emails or attachments, and file messages by sender or content will cut back a lot of time spent in your inbox. If you’re constantly checking your email to try to communicate with your team, you’re taking attention away from other necessary office tasks. Instead, organize your inbox, and reprioritize checking your email 2-3 times a day. You’ll thank yourself! 

Schedule Most Things…But Not Everything. 

It is often encouraged to plan each part of your day. This can be tempting, as it feels logical to know how and where to spend your time. Before doing this, think about how much of your day is reactive. More specifically, how much of your day is absorbed by issues and events that arise on the day and need immediate attention? Typically, it’s more than you may think. By engaging in the discipline of only planning highly prioritized parts of your day and leaving approximately 50% of it unplanned for necessary reaction, you are building a more sustainable schedule. 

Add More Time to Remain Realistic. 

Sometimes, when asked, “When can you have this to me by?” we respond habitually instead of realistically. It can be instinctive to give the soonest possible deadline for projects and reports, wanting to please clients and peers. However, days spent as a leader require a large chunk of time to be dedicated to unanticipated situations. Try to find extra space to build in reactive time by pushing deadlines out a day or two, or even a week depending on the size of the project. Doing this is often met with the response, “That’s fine, thanks.”  

Delegate, Delegate, Delegate. 

You can do anything, but you can’t do everything, and it is important to trust your team and their abilities. In other words, know when to be hands-off, and know when to delegate tasks. To save yourself time and empower your employees, it is crucial to know when to pass tasks to those who have the skills and knowledge necessary to complete projects that you may not need to be an integral part of. Focus on a few of the things that you do best, and delegate the rest. 

Ask For Help.

Even the best of leaders may feel overwhelmed and need to ask for assistance. When you can’t do it all by yourself, CSG is here to help. Reach out to our team to learn about how we can offer talented consultants and customized functional services for all of your biopharma needs, or download our Customized Functional Services Information Sheet.

For more tips on how to improve productivity and time management throughout the day, review our article Goal Setting: How to Have a More Productive Workday.

Goal Setting: How to Have a More Productive Workday

Whether you’re a corporate leader or a remote worker who makes their own schedule, it can be difficult to remain productive and finish a day’s work by a reasonable hour. No matter how much you enjoy your job, it is a common problem to feel burnt out or have moments of distraction during the workday. However, these problems could potentially be fixed with just a few adjustments to behaviors and habits: 

  1. Start Your Day with a Complex Task
    Although it has been said that the hardest part of any project is getting started, it is also known that your attention span and motivation levels are the highest at the beginning of a workday. With that in mind, block out some time at the start of the day to make progress on a difficult task while your mental energy is more powerful. 
  2. Take Several Short Breaks
    It is easy to get caught up in your work and forget to take a break, especially if you’re feeling overwhelmed with projects and deadlines. However, working long hours without stopping can lead to poor performance. Instead, take a walk for a few minutes every hour or have a short conversation with a colleague to reset your attention span, sharpen your focus, and improve your mood. 
  3. Don’t Use the Internet Unless You Need It
    With the strong presence of social media in society, opening your browser or using your phone at work can become a huge distraction and slow down productivity. Rather than getting online, tuck your phone away and use the programs that are on your computer to avoid logging into social networks and becoming less productive. 
  4. Don’t Eat Lunch at Your Desk
    Eating lunch at your desk can seem like a good choice when trying to multitask and meet deadlines. Unfortunately, this is not the case and can be counterproductive. Eating lunch away from your desk will result in a better outlook on the rest of the day, and it gives you the opportunity to relax and hang out with coworkers or take a moment of alone time.  
  5. Pace Yourself
    If your day is not well-planned, a significant amount of your time may end up being wasted. Use the first part of your day to get organized and review your goals and schedule. Try to work ahead and anticipate set-backs. Consider how much time projects and tasks have taken you in the past and determine how you can break them into smaller parts. Figuring out what you must do, when you can do it, and how long it will take is a huge step towards productivity. 

Plan your workdays purposefully to remain productive, and reach out to your CSG Recruiter in times of stress or need. We go to great lengths to understand each of your short and long-term goals and want to work with you to improve your strengths and tackle any challenges that arise.

Body Language Mistakes You Might Be Making At Work

Communication isn’t just verbal. During conversation, you may be saying very few words but giving off dozens of non-verbal cues and hints. These cues are just as important as your words, however, and may be crucial to your interactions and success at work. Even though you are meeting deadlines and are dedicated to your job, it may be your actions that are separating you from your next promotion. Below are some of the most common body language mistakes that you could be making without even noticing that you make them: 

Fidgeting 

One of the most distracting body language mistakes made in the workplace, fidgeting may be anything from playing with your pen, twirling your hair, or tapping your feet. These habits can make your colleagues think that you aren’t completely tuned into the conversation, and they can distract others that are. Instead, try to channel your energy into making eye-contact, keeping your hands visible, and sitting up straight to better engage in conversation. 

Bad Posture 

Slouching at your desk is easy after long hours at work, but it can also convey that you aren’t as put-together as you’d like to be. Even worse, it might make you seem negative or bored at work, telling your colleagues and bosses that you aren’t excited to be there. If you find yourself slouching often, use your desk chair to your advantage by sitting as far back as possible and using the back rest as support. This will align you with your chair and keep you from exhibiting bad posture. 

Crossing Your Arms 

Even if crossing your arms has nothing to do with the person you’re speaking to, it might make them feel that you are being closed off in the conversation. Separating yourself in this way can convey that you aren’t engaged or aren’t friendly, which will make your colleagues feel less comfortable when talking to you. To avoid this, try to keep your hands by your side and orient your body towards the person you’re talking with to show openness and engagement. 

Lack of Eye Contact 

Not making eye contact with others at work tells them that you’re too busy to converse with them or are not interested in talking. Additionally, looking at the floor or tilting your face downward can show that you are insecure. If it is your phone that keeps you from making eye contact, put it away. Instead, try to smile and look people in their eyes when passing them in the halls or holding conversation. 

Being Overly Casual 

In today’s world, businesses are becoming more casual and adopting modern values that encourage comfort and happiness. With this, comes more casual dress and attitudes at work. However, people often take this a little too far and end up walking down the office halls like they’re in their own homes. Remember to carry yourself with confidence and poise around the office. 

If you’re unsure of other body language mistakes you may be making, ask peers for feedback. Another helpful tactic is to identify someone you admire at work and take note of their habits. Above all else, be aware of how you are presenting yourself in the workplace, as this can be vital in your success.