All posts by Jillian Lewis

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.

Jim Balcom Joins CSG as VP of Business Development

 

Clinical Solutions Group is pleased to announce that Jim Balcom has joined the team as our new Vice President of Business Development!  Jim brings two decades of local and international experience at companies with disciplines spanning Statistical Programming, Biostatistics, Outsourcing, Consulting and Global FSP Programs.

Prior to CSG, Jim served as the VP of Business Development and Operations for a specialized Life Sciences Functional Service Provider with global service offerings. His responsibilities included heading new business development, leading sales and recruiting team operations, and maintaining strong partnerships with software companies.

Jim has a wealth of experience in the Life Sciences Data Analysis Industry, and we couldn’t be more excited to combine Jim’s veteran leadership with the talent and opportunity we have here at CSG.