Category Archives: Company News

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. 

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.

Karen Curran Joins CSG as VP of Biometric Services

Clinical Solutions Group (Raleigh, NC) is pleased to announce the addition of Karen Curran, Vice President of Biometric Services to lead our Biometric Services Division. Karen joins Clinical Solutions Group as an executive with over 20-years of leadership experience providing solutions to pharmaceutical and biotech clients that range from small start-ups to some of the largest global companies in the industry, with a track record of developing sustainable and evolving relationships with those clients.

At CSG, Karen leads the biometrics group and works with sponsors to develop customised solutions; from individual placements, staff augmentation strategies or to developing customised FSP relationships. Karen brings her tenure of leadership experience to our clients for a solution that meeting the needs and culture of every engagement.

CSG’s FSP is a customizable solution that allows flexibility in your projects, contractual terms, engagement models, and cost strategies. CSG carefully calibrates a delivery framework for the unique challenges and objectives of every sponsor environment.  Our approach is highly collaborative so that our customers’ perspective is clearly represented in the final solution and they maintain confidence the partnership is designed specific to their needs.

Karen’s expertise includes CDISC compliant submissions planning and execution, developing KPIs and usable metrics in support of strategic partnerships and in managing sponsor relationships, project delivery and resourcing. Prior to CSG, Karen led the global biometrics group of a large CRO with over 400 statisticians and statistical programmers worldwide and lead customised biometrics solutions for their key accounts.

LinkedIn Profile

The Space Between Staffing and Outsourcing

Staff augmentation and the CRO model have long been the only choices when biotech companies need to look beyond their full-time staff to get work done.  Each of these two models still have their inherent value propositions but a 20-year career in the staffing and services industry has revealed many lessons learned. Most notably is the realization that often customer needs are best met with a customized solution in which stakeholder-ship is carefully calibrated for the unique goals and challenges at hand.

Staff augmentation is typically sought after for its ease of engagement and flexibility while the true outsource is best when you need the tools, thought leadership and skin in the game to achieve the outcomes you seek.  A trend with key sponsors is the call for engagement models that allow them to maintain control of project direction while still getting a solution that has defined accountability to business outcomes.

Many sponsors have invested heavily in tools, SOP’s and now organizational standards for development and data management.  This reality reduces their dependency on fully outsourcing a project to a CRO that brings these tools to the table. The preference is shifting towards finding specialized partners to do work inside their established environments to avoid rifts with organizational standards as well as the challenges and costs associated with accessing outsourced trial data.

Sponsors often have the thought leadership in house and primarily need resources to execute established project plans.  The staff augmentation model that was so widely used is now governed by strict tenure rules to mitigate co-employment risks presenting a significant challenge to multi-year efforts.

The most progressive leaders in biopharma are calling for solutions that start with a partner’s ability to deliver highly skilled teams but they require more than the traditional staff augmentation model can offer.   The perfect space between staff augmentation and full service outsourcing must be determined at a project level so that the sponsor receives a service framework in which their chosen partner is accountable to the outcome without sacrificing the control and flexibility the sponsor desires. Full outsourcing drives up costs as the partner brings with it more tools, resources and overhead than necessary to achieve project goals.  Conversely, when relying only on resourcing, the burden of project execution lies solely on internal resources. When the service attributes and measurements are developed for the unique needs of the project, no more and no less, the customer achieves an optimal value proposition.

For examples of how Clinical Solutions Group can customize solutions using our six key service tenants check out this interactive element  on our website

Where it all started

 

Clinical Solutions Group was founded in 1999 by bothers Omar and Imad Omar. Having been in the industry for several years they recognized the need for a niche firm to fill what they saw as a service gap in the Biopharma industry. Over the last 19 years the brothers have lead Clinical Solutions Group to become a company held in high regard across the Pharmaceutical and Clinical Trial industry nationwide by focusing on delivering a personable experience for both the consultant and the client.

As they entered 2017, the brothers recognized another service gap in the industry. Combined with a new branding efforts, Clinical Solutions Group has launched an FSP offering, addressing customer demands to become a larger stakeholder in their project goals, working collaboratively with them on well defined standards, systems and tools leveraged internally.

We often field questions about our company’s heritage and where we are going. Our team thinks more people would be interested in hearing about this so Imad and Omar put together some answers to our most frequent questions.

  1. What was your motivation for starting Clinical Solutions Group?

    Having been in the industry for over 7 years prior to starting CSG, our motivation was to start a company that specifically focused on a finite number of skill sets and establish CSG as niche firm supporting the Biopharma industry. Our goal was to provide our employees a company that felt more like a home environment rather than just a place of employment. While we knew that was the way we wanted our company to run, we also strongly believed this would also attract clients to our firm, help attract the top talent in the marketplace, and overall lead to longer and more fulfilling careers for our team.

  2. What is a major obstacle that you have overcome since starting the company?

    The main obstacle we’ve faced has been to compete at a high level in both the consultant market as well as the client market against the larger staffing companies. We found that we have been able to overcome those hurdles by a driven focus on superior customer service, creating a more personal experience for the consultant, and by focusing on the more niche skillsets within the clinical arena that our clients would appreciate. We quickly understood that CSG cannot be everything to everybody and that niche focus has made us very competitive in the market.

  3. What is the most important thing that you have learned over the last two decades?

    Treating consultants and customers alike with respect and providing service rooted in quality and integrity is the focus beyond revenues and profit. Business results have a funny way of happening when you do the right thing by others.

  4. Where do you see the future of Clinical Solutions Group, and what about that future most excites you?

    All the business KPI’s are trending up and we remain proud of the value we drive in the marketplace and now we’re leveraging our strong foundation to enter into new service frameworks like Functional Service Provider (FSP) models. Moreover, we feel that we offer our employees a great work environment focused on building personal relationships and are excited about the opportunity  that will be created for our employees to realize the personal and professional goals that matter to them.

CSG in 2017

Clinical Solutions Group is starting off 2017 with a bang. A brilliant new logo & website, a gorgeous new office, and an innovative new service offering. These are just a few of the exciting improvements that Clinical Solutions Group has in store for 2017.

Staffing Services Excellence:

This year, CSG will be striving to constantly enhance the consultant experience and be the career partner our valued consultants deserve. Since our inception in 1999, CSG has helped our consultants achieve their goals by connecting them with our vast network of clients in the biopharma industry. Our talent acquisition team believes in taking the time to build a strong relationship with our consultants, and our candidates love the experience of having CSG as their career partner. Just read what they have to say for yourself.

Customized Biometric Functional Services:

After 18 years in business, our expertise in the biopharma space has grown tremendously, bringing over 140 years of collective experience to the table through our leadership team. This natural evolution has equipped CSG to launch an innovative flexible functional service model that fills the service gap between traditional staffing and outsourcing models. CSG is excited to offer our clients individually crafted and carefully calibrated FSP models that strike the perfect balance between the flexibility and control customers need and the stakeholdership they should expect from a partner.

CSG can deliver the solution that you need for your trial, read more about our Customized FSP Solutions today.

Internal Team Growth:

With the move into a new, larger office, Clinical Solutions Group is committed to growing and strengthening our Talent and Sales teams. A people-first approach, combined with our high performance/ high reward environment creates an exceptional entrepreneurial-like culture. Take your first steps towards becoming a part of our team today by browsing our open positions.