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Part 2 | ICH E6 (R3) Quality by Design: Transforming Clinical Trial Standards
The recent ICH E6 (R3) update is more than just another revision to Good Clinical Practice, it’s an invitation for the industry to rethink how trials are designed and managed. At the center of this shift is Quality by Design (QbD) and risk-proportionality, two powerful ideas that encourage us to build trials that are smarter,…
Read MoreFSP vs. CRO vs. Direct Hire: Which Clinical Research Model Works Best?
The clinical research landscape offers multiple pathways for building and managing your trial teams. Each approach brings distinct advantages and challenges that can significantly impact your study outcomes, timelines, and budget. Understanding these differences isn’t just about choosing a vendor, it’s about aligning your resourcing strategy with your organizational goals, project complexity, and long-term vision.…
Read MoreICH E6 (R3) Guidelines: What These Updates Mean for Clinical Research
On January 6, 2025, the International Council for Harmonisation (ICH) endorsed the ICH E6 (R3) guidelines under Step 4. This marks a significant evolution in Good Clinical Practice (GCP), building on earlier versions while addressing the realities of today’s research environment. The revision emphasizes data integrity, proportionate risk management, and clearer stakeholder responsibilities, all of…
Read MoreRapid Staffing Solution for Oncology Clinical Trial
Background Vita Global Sciences (VGS) specializes in providing tailored professional services for life sciences companies. Our client, a leading pharmaceutical company, had an urgent need for a Clinical Research Associate (CRA) with specific oncology experience in a particular region. Given the complexity and specificity of the role, the client required a quick turnaround to avoid…
Read MoreGlobal Clinical Supply Resources
Background A leading pharmaceutical company sought to diversify its supplier base by identifying a strategic resourcing partner capable of sourcing Global Clinical Supply (GCS) resources for its New Jersey and Pennsylvania operations. To achieve this, the company decided to optimize its operations through a Functional Services Provider (FSP) solution, with the specific goals of attracting…
Read MoreFSP Solutions: The Future Industry Standard in Life Sciences Outsourcing
As the life sciences industry rapidly evolves to meet increasing demands for speed, innovation, and cost efficiency, outsourcing models are transforming accordingly. Functional Service Provider (FSP) solutions are emerging as the new industry standard, bridging the gap between traditional Staffing and Full-Service Outsourcing (FSO). For clinical research organizations, adapting to the growth of the FSP…
Read MoreEffective Leadership In Statistical Programming: Building Resilient And Client-Centric Teams
At Vita Global Sciences, we are committed to driving innovation and excellence in Biometrics. Our Executive Director, Sivakumar Ramakrishnan, shares key insights in his latest Forbes Technology Council article on how leaders can build resilient and client-focused teams in the evolving data-driven landscape. Key takeaways: – Fostering innovation and enhancing efficiency in statistical programming –…
Read MoreWhy life sciences clients want more than staffing: The rise of FSP
Congratulations to Benjamin P Stephenson, SVP of Operations and Strategy at Vita Global Sciences, for having his article, “Why Life Sciences Clients Want More Than Staffing: The Rise of FSP,” recently published on the Staffing Industry Analysts website. Ben’s article dives into the key factors driving the demand for Functional Service Providers (FSPs) in the…
Read MoreBreaking Into Statistical Programming: The Evolving Role Of SAS, R, Python, AI And ML
We are thrilled to share that our talented colleague Kishore Pothuri has been featured on Forbes.com! In this insightful article, Kishore explores how the world of statistical programming is evolving—and what that means for the next generation of professionals in data science and biostatistics. Whether you’re just starting out or navigating your career in this…
Read MoreControlling Costs While Maintaining Quality in Biostatistics and Statistical Programming
VGS’s latest white paper, Controlling Costs While Maintaining Quality in Biostatistics and Statistical Programming. From hybrid models to AI integration and automation, this paper explores actionable strategies for smarter, more efficient operations. Download White Paper
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